Faculty

TARGET AUDIENCE
This activity is intended for medical and radiation oncologists, urologists and other healthcare providers involved in the treatment of urothelial bladder cancer.

LEARNING OBJECTIVES

• Analyze the biological basis for the use of perioperative immune checkpoint inhibitor therapy or perioperative immune checkpoint inhibitor therapy in combination with antibody-drug conjugate therapy for patients with muscle-invasive bladder cancer (MIBC), and evaluate available and emerging data documenting the efficacy and safety of these strategies.
• Develop an understanding of the clinical relevance of circulating tumor DNA (ctDNA) as a prognostic and predictive biomarker in MIBC, and evaluate available data documenting the benefit of adjuvant anti-PD-1/PD-L1 antibody therapy for patients with positive ctDNA test results after cystectomy.
• Assess the biological rationale for, available research findings with and potential role of promising investigational strategies for non-muscle-invasive bladder cancer and MIBC.

ACCREDITATION STATEMENT
Research To Practice is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

CREDIT DESIGNATION STATEMENT
Research To Practice designates this enduring material for a maximum of 0.25 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

PRIVACY POLICY
Personal information and data sharing: Research To Practice aggregates deidentified user data for program-use analysis, program development, activity planning and site improvement. We may provide aggregate and deidentified data to third parties, including commercial supporters. We do not share or sell personally identifiable information to any unaffiliated third parties or commercial supporters. Please see our privacy policy at ResearchToPractice.com/Privacy-Policy for more information.

HOW TO USE THIS CME ACTIVITY
To receive credit for this activity, the participant should review the CME information, watch the video and fill out the evaluation.

CONTENT VALIDATION AND DISCLOSURES
Research To Practice (RTP) is committed to providing its participants with high-quality, unbiased and state-of-the-art education and adheres to the ACCME’s Standards for Integrity and Independence in Accredited Continuing Education. Any individuals in a position to control the content of an accredited continuing education activity, including faculty, planners, reviewers and others, are required to disclose all relevant financial relationships with ineligible entities (commercial interests). All relevant financial relationships have been mitigated prior to the commencement of this activity. In addition, all activity content is reviewed by RTP scientific staff and an external, independent physician reviewer for fair balance, scientific objectivity of studies referenced and patient care recommendations.

FACULTY — The following faculty reported relevant financial relationships with ineligible entities:

Dr Galsky — Contracted Research: Astellas, Merck, Seagen Inc; Travel Support: Pfizer Inc. Dr Gupta — Advisory Committees: Bristol Myers Squibb, Merck, Novartis, Pfizer Inc, Tyra Biosciences Inc; Consulting Agreements: Astellas, AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, Bristol Myers Squibb, Convergent Therapeutics Inc, Foundation Medicine, Johnson & Johnson, Merck, Pfizer Inc; Contracted Research: Amgen Inc, Bristol Myers Squibb, Convergent Therapeutics Inc, Flare Therapeutics, Merck, Novartis, Pfizer Inc, Roche Laboratories Inc, Tyra Biosciences Inc; Data and Safety Monitoring Boards/Committees: Protara Therapeutics. Prof Necchi — Advisory Committees: Bristol Myers Squibb, CatalYm, Daiichi Sankyo Inc, Genenta Science, Johnson & Johnson, Merck; Consulting Agreements: AstraZeneca Pharmaceuticals LP, Gilead Sciences Inc, Johnson & Johnson, Merck, Pfizer Inc, Samsung Bioepis; Contracted Research: AstraZeneca Pharmaceuticals LP, Bristol Myers Squibb, Merck.

MODERATOR
Dr Friedlander — Advisory Committees: Aadi Bioscience, AbbVie Inc, Adaptimmune, Aktis Oncology, Astellas, Bicycle Therapeutics, Bristol Myers Squibb, Gilead Sciences Inc, Merck, Pfizer Inc, Samsung Bioepis; Consulting Agreements: Astellas, EMD Serono Inc, Genentech, a member of the Roche Group; Contracted Research: AbbVie Inc, Bicycle Therapeutics, Flare Therapeutics, Genentech, a member of the Roche Group, Johnson & Johnson, Pfizer Inc.

EDITOR — Dr Love is president and CEO of Research To Practice. Research To Practice receives funds in the form of educational grants to develop CME activities from the following companies: Aadi Bioscience, AbbVie Inc, ADC Therapeutics, Agendia Inc, Alexion Pharmaceuticals, Amgen Inc, Array BioPharma Inc, a subsidiary of Pfizer Inc, Arvinas, Astellas, AstraZeneca Pharmaceuticals LP, Aveo Pharmaceuticals, Bayer HealthCare Pharmaceuticals, BeOne, Biotheranostics Inc, A Hologic Company, Black Diamond Therapeutics Inc, Blueprint Medicines, Boehringer Ingelheim Pharmaceuticals Inc, Bristol Myers Squibb, Catalyst Pharmaceuticals Inc, Celcuity, Clovis Oncology, Coherus BioSciences, Corcept Therapeutics Inc, CTI BioPharma, a Sobi Company, Daiichi Sankyo Inc, Eisai Inc, Elevation Oncology Inc, Exact Sciences Corporation, Exelixis Inc, Genentech, a member of the Roche Group, Genmab US Inc, Geron Corporation, Gilead Sciences Inc, GSK, Helsinn Therapeutics (US) Inc, ImmunoGen Inc, Incyte Corporation, Ipsen Biopharmaceuticals Inc, Jazz Pharmaceuticals Inc, Johnson & Johnson, Karyopharm Therapeutics, Kite, A Gilead Company, Kura Oncology, Legend Biotech, Lilly, MEI Pharma Inc, Merck, Mersana Therapeutics Inc, Mirati Therapeutics Inc, Mural Oncology Inc, Natera Inc, Novartis, Novartis Pharmaceuticals Corporation on behalf of Advanced Accelerator Applications, Novocure Inc, Nuvalent, Nuvation Bio Inc, Pfizer Inc, Pharmacyclics LLC, an AbbVie Company, Puma Biotechnology Inc, Regeneron Pharmaceuticals Inc, Revolution Medicines Inc, Rigel Pharmaceuticals Inc, R-Pharm US, Sanofi, Seagen Inc, Servier Pharmaceuticals LLC, SpringWorks Therapeutics Inc, Stemline Therapeutics Inc, Sumitomo Pharma America, Summit Therapeutics, Syndax Pharmaceuticals, Taiho Oncology Inc, Takeda Pharmaceuticals USA Inc, TerSera Therapeutics LLC, Tesaro, A GSK Company, and Verastem Inc.

RESEARCH TO PRACTICE CME PLANNING COMMITTEE MEMBERS, STAFF AND REVIEWERS — Planners, scientific staff and independent reviewers for Research To Practice have no relevant financial relationships to disclose.

This educational activity contains discussion of published and/or investigational uses of agents that are not indicated by the Food and Drug Administration. Research To Practice does not recommend the use of any agent outside of the labeled indications. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications and warnings. The opinions expressed are those of the presenters and are not to be construed as those of the publisher or grantors.

This activity is supported by educational grants from Genentech, a member of the Roche Group, Johnson & Johnson, and Natera Inc.

Release date: August 2026
Expiration date: August 2027

Daneshmand S et al. Erdafitinib in patients with high- and intermediate-risk non–muscle-invasive bladder cancer: Final analysis of THOR-2 study. Eur Urol 2026;89(2):165-73. Abstract

De Santis M et al. Durvalumab (D) in combination with Bacillus Calmette-Guérin (BCG) for BCG-naïve, high-risk non-muscle-invasive bladder cancer (NMIBC): Final analysis of the phase III, open-label, randomised POTOMAC trial. ESMO 2025;Abstract LBA108.

Galsky M et al. Adjuvant nivolumab vs placebo for high-risk muscle-invasive urothelial carcinoma: 5-year efficacy and ctDNA results from CheckMate 274. ESMO 2025;Abstract 3068O.

Galsky MD et al. Adjuvant nivolumab in high-risk muscle-invasive urothelial carcinoma: Expanded efficacy from CheckMate 274. J Clin Oncol 2025;43(1):15-21. Abstract

Galsky MD et al. Adjuvant nivolumab versus placebo for high-risk muscle-invasive urothelial carcinoma: 5-year efficacy and ctDNA results from CheckMate 274. Ann Oncol 2026;37(1):69-78. Abstract

Guerrero-Ramos F et al. Association of molecular markers with clinical response to TAR-200 in the phase IIb SunRISe-1 trial in patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary disease. ESMO 2025;Abstract 3088P.

Guerrero-Ramos F et al. TAR-200 monotherapy in patients with Bacillus Calmette-Guérin–unresponsive papillary disease–only high-risk non–muscle-invasive bladder cancer: First results from cohort 4 of SunRISe-1. AUA 2025;Abstract.

Jacob JM et al. TAR-200 monotherapy in patients with Bacillus Calmette-Guérin–unresponsive high-risk non–muscle-invasive bladder cancer carcinoma in situ: 1-year durability and patient-reported outcomes from SunRISe-1. AUA 2025;Abstract.

Kamat AM et al. Definitions, end points, and clinical trial designs for non-muscle-invasive bladder cancer: Recommendations from the International Bladder Cancer Group. J Clin Oncol 2016;34(16):1935-44. Abstract

Knowles MA, Hurst CD. Molecular biology of bladder cancer: New insights into pathogenesis and clinical diversity. Nat Rev Cancer 2015;15:25-41. Abstract

Li R et al. Bladder-sparing therapy for Bacillus Calmette-Guérin-unresponsive non-muscle-invasive bladder cancer: International Bladder Cancer Group recommendations for optimal sequencing and patient selection. Eur Urol 2024 Dec;86(6):516-27. Abstract

Necchi A et al. Gemcitabine intravesical system (Gem-iDRS) in combination with cetrelimab (CET) versus chemoradiotherapy (CRT) in muscle-invasive bladder cancer (MIBC): SunRISe-2 final results. Genitourinary Cancers Symposium 2026;Abstract 635.

Necchi A et al. Gemcitabine intravesical system plus cetrelimab or cetrelimab alone as neoadjuvant therapy in muscle-invasive bladder cancer: SunRISe-4 primary analysis and biomarker results. J Clin Oncol 2026;44(7):586-97. Abstract

Powles T et al. Circulating tumor DNA (ctDNA) in patients with muscle-invasive bladder cancer (MIBC) who received perioperative durvalumab (D) in NIAGARA. ASCO 2025;Abstract 4503.

Powles T et al. ctDNA-guided adjuvant atezolizumab in muscle-invasive bladder cancer. N Engl J Med 2025;393(24):2395-408. Abstract

Powles T et al. Sasanlimab in combination with bacillus Calmette-Guérin (BCG) in BCG-naive, high-risk non–muscle-invasive bladder cancer (NMIBC): Event-free survival (EFS) subgroup analyses based on disease stage from the CREST study. ASCO 2025;Abstract 4517.

Powles T et al. Enfortumab vedotin and pembrolizumab in untreated advanced urothelial cancer. N Engl J Med 2024;390(10):875-88. Abstract

Powles J et al. Perioperative durvalumab with neoadjuvant chemotherapy in operable bladder cancer. N Engl J Med 2024;391(19):1773-86. Abstract

Powles T et al. A randomized phase III trial of neoadjuvant durvalumab plus chemotherapy followed by radical cystectomy and adjuvant durvalumab in muscle-invasive bladder cancer (NIAGARA). ESMO 2024;Abstract LBA5.

Powles T et al. ctDNA guiding adjuvant immunotherapy in urothelial carcinoma. Nature 2021;595(7867):432-7. Abstract

Roupret M et al. ALBAN: A phase III, randomized, open-label, international study of intravenous (iv) atezolizumab and intravesical Bacillus Calmette-Guérin (BCG) vs BCG alone in BCG-naïve high-risk, non-muscle-invasive bladder cancer (NMIBC). ESMO 2025;Abstract LBA107.

Shore ND et al. Sasanlimab in combination with Bacillus Calmette-Guérin improves event-free survival versus Bacillus Calmette-Guérin as standard of care in high-risk non- muscle-invasive bladder cancer: Phase 3 CREST study results. AUA 2025;Abstract.

Steinberg GD et al. CREST: Phase III study of sasanlimab and Bacillus Calmette-Guérin for patients with Bacillus Calmette-Guérin-naïve high-risk non-muscle-invasive bladder cancer. Future Oncol 2024;20(14):891-901. Abstract

Tyson MD, et al. Pivotal results from BOND-003: A phase 3, single-arm study of intravesical cretostimogene grenadenorepvec for the treatment of high risk, BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ. AUA 2024;Abstract P2-02.

Vilaseca A et al. First safety and efficacy results of the TAR-210 erdafitinib intravesical delivery system in patients with non–muscle-invasive bladder cancer with select FGFR alterations. AUA 2024;Abstract PD48-02.

Vulsteke C et al. Perioperative (periop) enfortumab vedotin (EV) plus pembrolizumab (pembro) in participants (pts) with muscle-invasive bladder cancer (MIBC) who are cisplatin-ineligible: The phase III KEYNOTE-905 study. ESMO 2025;Abstract LBA2.

Vulsteke C et al. Perioperative enfortumab vedotin and pembrolizumab in bladder cancer. N Engl J Med 2026;394:1257-69. Abstract

Wiesen B et al. Updated review on novel therapies and ongoing clinical trials for high-risk non-muscle invasive bladder cancer. Front Oncol 2025;15:1519428. Abstract

Faculty

TARGET AUDIENCE
This activity is intended for medical and radiation oncologists, urologists and other healthcare providers involved in the treatment of urothelial bladder cancer.

LEARNING OBJECTIVES

• Optimize the management of high-risk non-muscle-invasive bladder cancer (NMIBC) that is unresponsive to bacillus Calmette-Guérin, considering the efficacy and tolerability of FDA-endorsed therapies.
• Review available clinical trial evidence with novel intravesical therapies for NMIBC, and optimally incorporate these approaches into the care of appropriately selected patients.
• Analyze the biological basis for the use of perioperative immune checkpoint inhibitor therapy or perioperative immune checkpoint inhibitor therapy in combination with antibody-drug conjugate therapy for patients with muscle-invasive bladder cancer, and evaluate available and emerging data documenting the efficacy and safety of these strategies.

ACCREDITATION STATEMENT
Research To Practice is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

CREDIT DESIGNATION STATEMENT
Research To Practice designates this enduring material for a maximum of 0.25 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

PRIVACY POLICY
Personal information and data sharing: Research To Practice aggregates deidentified user data for program-use analysis, program development, activity planning and site improvement. We may provide aggregate and deidentified data to third parties, including commercial supporters. We do not share or sell personally identifiable information to any unaffiliated third parties or commercial supporters. Please see our privacy policy at ResearchToPractice.com/Privacy-Policy for more information.

HOW TO USE THIS CME ACTIVITY
To receive credit for this activity, the participant should review the CME information, watch the video and fill out the evaluation.

CONTENT VALIDATION AND DISCLOSURES
Research To Practice (RTP) is committed to providing its participants with high-quality, unbiased and state-of-the-art education and adheres to the ACCME’s Standards for Integrity and Independence in Accredited Continuing Education. Any individuals in a position to control the content of an accredited continuing education activity, including faculty, planners, reviewers and others, are required to disclose all relevant financial relationships with ineligible entities (commercial interests). All relevant financial relationships have been mitigated prior to the commencement of this activity. In addition, all activity content is reviewed by RTP scientific staff and an external, independent physician reviewer for fair balance, scientific objectivity of studies referenced and patient care recommendations.

FACULTY — The following faculty reported relevant financial relationships with ineligible entities:

Dr Galsky — Contracted Research: Astellas, Merck, Seagen Inc; Travel Support: Pfizer Inc. Dr Gupta — Advisory Committees: Bristol Myers Squibb, Merck, Novartis, Pfizer Inc, Tyra Biosciences Inc; Consulting Agreements: Astellas, AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, Bristol Myers Squibb, Convergent Therapeutics Inc, Foundation Medicine, Johnson & Johnson, Merck, Pfizer Inc; Contracted Research: Amgen Inc, Bristol Myers Squibb, Convergent Therapeutics Inc, Flare Therapeutics, Merck, Novartis, Pfizer Inc, Roche Laboratories Inc, Tyra Biosciences Inc; Data and Safety Monitoring Boards/Committees: Protara Therapeutics. Prof Necchi — Advisory Committees: Bristol Myers Squibb, CatalYm, Daiichi Sankyo Inc, Genenta Science, Johnson & Johnson, Merck; Consulting Agreements: AstraZeneca Pharmaceuticals LP, Gilead Sciences Inc, Johnson & Johnson, Merck, Pfizer Inc, Samsung Bioepis; Contracted Research: AstraZeneca Pharmaceuticals LP, Bristol Myers Squibb, Merck.

MODERATOR
Dr Friedlander — Advisory Committees: Aadi Bioscience, AbbVie Inc, Adaptimmune, Aktis Oncology, Astellas, Bicycle Therapeutics, Bristol Myers Squibb, Gilead Sciences Inc, Merck, Pfizer Inc, Samsung Bioepis; Consulting Agreements: Astellas, EMD Serono Inc, Genentech, a member of the Roche Group; Contracted Research: AbbVie Inc, Bicycle Therapeutics, Flare Therapeutics, Genentech, a member of the Roche Group, Johnson & Johnson, Pfizer Inc.

EDITOR — Dr Love is president and CEO of Research To Practice. Research To Practice receives funds in the form of educational grants to develop CME activities from the following companies: Aadi Bioscience, AbbVie Inc, ADC Therapeutics, Agendia Inc, Alexion Pharmaceuticals, Amgen Inc, Array BioPharma Inc, a subsidiary of Pfizer Inc, Arvinas, Astellas, AstraZeneca Pharmaceuticals LP, Aveo Pharmaceuticals, Bayer HealthCare Pharmaceuticals, BeOne, Biotheranostics Inc, A Hologic Company, Black Diamond Therapeutics Inc, Blueprint Medicines, Boehringer Ingelheim Pharmaceuticals Inc, Bristol Myers Squibb, Catalyst Pharmaceuticals Inc, Celcuity, Clovis Oncology, Coherus BioSciences, Corcept Therapeutics Inc, CTI BioPharma, a Sobi Company, Daiichi Sankyo Inc, Eisai Inc, Elevation Oncology Inc, Exact Sciences Corporation, Exelixis Inc, Genentech, a member of the Roche Group, Genmab US Inc, Geron Corporation, Gilead Sciences Inc, GSK, Helsinn Therapeutics (US) Inc, ImmunoGen Inc, Incyte Corporation, Ipsen Biopharmaceuticals Inc, Jazz Pharmaceuticals Inc, Johnson & Johnson, Karyopharm Therapeutics, Kite, A Gilead Company, Kura Oncology, Legend Biotech, Lilly, MEI Pharma Inc, Merck, Mersana Therapeutics Inc, Mirati Therapeutics Inc, Mural Oncology Inc, Natera Inc, Novartis, Novartis Pharmaceuticals Corporation on behalf of Advanced Accelerator Applications, Novocure Inc, Nuvalent, Nuvation Bio Inc, Pfizer Inc, Pharmacyclics LLC, an AbbVie Company, Puma Biotechnology Inc, Regeneron Pharmaceuticals Inc, Revolution Medicines Inc, Rigel Pharmaceuticals Inc, R-Pharm US, Sanofi, Seagen Inc, Servier Pharmaceuticals LLC, SpringWorks Therapeutics Inc, Stemline Therapeutics Inc, Sumitomo Pharma America, Summit Therapeutics, Syndax Pharmaceuticals, Taiho Oncology Inc, Takeda Pharmaceuticals USA Inc, TerSera Therapeutics LLC, Tesaro, A GSK Company, and Verastem Inc.

RESEARCH TO PRACTICE CME PLANNING COMMITTEE MEMBERS, STAFF AND REVIEWERS — Planners, scientific staff and independent reviewers for Research To Practice have no relevant financial relationships to disclose.

This educational activity contains discussion of published and/or investigational uses of agents that are not indicated by the Food and Drug Administration. Research To Practice does not recommend the use of any agent outside of the labeled indications. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications and warnings. The opinions expressed are those of the presenters and are not to be construed as those of the publisher or grantors.

This activity is supported by educational grants from Genentech, a member of the Roche Group, Johnson & Johnson, and Natera Inc.

Release date: August 2026
Expiration date: August 2027

Daneshmand S et al. Erdafitinib in patients with high- and intermediate-risk non–muscle-invasive bladder cancer: Final analysis of THOR-2 study. Eur Urol 2026;89(2):165-73. Abstract

De Santis M et al. Durvalumab (D) in combination with Bacillus Calmette-Guérin (BCG) for BCG-naïve, high-risk non-muscle-invasive bladder cancer (NMIBC): Final analysis of the phase III, open-label, randomised POTOMAC trial. ESMO 2025;Abstract LBA108.

Galsky M et al. Adjuvant nivolumab vs placebo for high-risk muscle-invasive urothelial carcinoma: 5-year efficacy and ctDNA results from CheckMate 274. ESMO 2025;Abstract 3068O.

Galsky MD et al. Adjuvant nivolumab in high-risk muscle-invasive urothelial carcinoma: Expanded efficacy from CheckMate 274. J Clin Oncol 2025;43(1):15-21. Abstract

Galsky MD et al. Adjuvant nivolumab versus placebo for high-risk muscle-invasive urothelial carcinoma: 5-year efficacy and ctDNA results from CheckMate 274. Ann Oncol 2026;37(1):69-78. Abstract

Guerrero-Ramos F et al. Association of molecular markers with clinical response to TAR-200 in the phase IIb SunRISe-1 trial in patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary disease. ESMO 2025;Abstract 3088P.

Guerrero-Ramos F et al. TAR-200 monotherapy in patients with Bacillus Calmette-Guérin–unresponsive papillary disease–only high-risk non–muscle-invasive bladder cancer: First results from cohort 4 of SunRISe-1. AUA 2025;Abstract.

Jacob JM et al. TAR-200 monotherapy in patients with Bacillus Calmette-Guérin–unresponsive high-risk non–muscle-invasive bladder cancer carcinoma in situ: 1-year durability and patient-reported outcomes from SunRISe-1. AUA 2025;Abstract.

Kamat AM et al. Definitions, end points, and clinical trial designs for non-muscle-invasive bladder cancer: Recommendations from the International Bladder Cancer Group. J Clin Oncol 2016;34(16):1935-44. Abstract

Knowles MA, Hurst CD. Molecular biology of bladder cancer: New insights into pathogenesis and clinical diversity. Nat Rev Cancer 2015;15:25-41. Abstract

Li R et al. Bladder-sparing therapy for Bacillus Calmette-Guérin-unresponsive non-muscle-invasive bladder cancer: International Bladder Cancer Group recommendations for optimal sequencing and patient selection. Eur Urol 2024 Dec;86(6):516-27. Abstract

Necchi A et al. Gemcitabine intravesical system (Gem-iDRS) in combination with cetrelimab (CET) versus chemoradiotherapy (CRT) in muscle-invasive bladder cancer (MIBC): SunRISe-2 final results. Genitourinary Cancers Symposium 2026;Abstract 635.

Necchi A et al. Gemcitabine intravesical system plus cetrelimab or cetrelimab alone as neoadjuvant therapy in muscle-invasive bladder cancer: SunRISe-4 primary analysis and biomarker results. J Clin Oncol 2026;44(7):586-97. Abstract

Powles T et al. Circulating tumor DNA (ctDNA) in patients with muscle-invasive bladder cancer (MIBC) who received perioperative durvalumab (D) in NIAGARA. ASCO 2025;Abstract 4503.

Powles T et al. ctDNA-guided adjuvant atezolizumab in muscle-invasive bladder cancer. N Engl J Med 2025;393(24):2395-408. Abstract

Powles T et al. Sasanlimab in combination with bacillus Calmette-Guérin (BCG) in BCG-naive, high-risk non–muscle-invasive bladder cancer (NMIBC): Event-free survival (EFS) subgroup analyses based on disease stage from the CREST study. ASCO 2025;Abstract 4517.

Powles T et al. Enfortumab vedotin and pembrolizumab in untreated advanced urothelial cancer. N Engl J Med 2024;390(10):875-88. Abstract

Powles J et al. Perioperative durvalumab with neoadjuvant chemotherapy in operable bladder cancer. N Engl J Med 2024;391(19):1773-86. Abstract

Powles T et al. A randomized phase III trial of neoadjuvant durvalumab plus chemotherapy followed by radical cystectomy and adjuvant durvalumab in muscle-invasive bladder cancer (NIAGARA). ESMO 2024;Abstract LBA5.

Powles T et al. ctDNA guiding adjuvant immunotherapy in urothelial carcinoma. Nature 2021;595(7867):432-7. Abstract

Roupret M et al. ALBAN: A phase III, randomized, open-label, international study of intravenous (iv) atezolizumab and intravesical Bacillus Calmette-Guérin (BCG) vs BCG alone in BCG-naïve high-risk, non-muscle-invasive bladder cancer (NMIBC). ESMO 2025;Abstract LBA107.

Shore ND et al. Sasanlimab in combination with Bacillus Calmette-Guérin improves event-free survival versus Bacillus Calmette-Guérin as standard of care in high-risk non- muscle-invasive bladder cancer: Phase 3 CREST study results. AUA 2025;Abstract.

Steinberg GD et al. CREST: Phase III study of sasanlimab and Bacillus Calmette-Guérin for patients with Bacillus Calmette-Guérin-naïve high-risk non-muscle-invasive bladder cancer. Future Oncol 2024;20(14):891-901. Abstract

Tyson MD, et al. Pivotal results from BOND-003: A phase 3, single-arm study of intravesical cretostimogene grenadenorepvec for the treatment of high risk, BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ. AUA 2024;Abstract P2-02.

Vilaseca A et al. First safety and efficacy results of the TAR-210 erdafitinib intravesical delivery system in patients with non–muscle-invasive bladder cancer with select FGFR alterations. AUA 2024;Abstract PD48-02.

Vulsteke C et al. Perioperative (periop) enfortumab vedotin (EV) plus pembrolizumab (pembro) in participants (pts) with muscle-invasive bladder cancer (MIBC) who are cisplatin-ineligible: The phase III KEYNOTE-905 study. ESMO 2025;Abstract LBA2.

Vulsteke C et al. Perioperative enfortumab vedotin and pembrolizumab in bladder cancer. N Engl J Med 2026;394:1257-69. Abstract

Wiesen B et al. Updated review on novel therapies and ongoing clinical trials for high-risk non-muscle invasive bladder cancer. Front Oncol 2025;15:1519428. Abstract

Faculty

TARGET AUDIENCE
This activity is intended for medical and radiation oncologists, urologists and other healthcare providers involved in the treatment of genitourinary cancers.

LEARNING OBJECTIVES

• Evaluate recently presented clinical research findings to determine their effect on the current management of localized or metastatic prostate cancer.
• Explore available data with treatment intensification for hormone-sensitive localized or metastatic prostate cancer, and effectively integrate FDA-approved strategies into current clinical management algorithms.
• Assess the available research database supporting PARP inhibitors in combination with androgen receptor pathway inhibitors for patients with metastatic prostate cancer harboring a homologous recombination repair gene alteration, and discern how to optimally incorporate these agents into current clinical management algorithms.
• Appreciate the biological rationale for targeting the PI3K/AKT/mTOR pathway for prostate cancer, and evaluate available data with novel AKT inhibitors in combination with hormonal therapy for patients with PTEN deficiency.
• Review available Phase III data documenting the efficacy of various forms of radioligand therapy for metastatic prostate cancer, and consider the current and potential future clinical role of these strategies.
• Optimize the management of non-muscle-invasive bladder cancer (NMIBC), considering the efficacy and tolerability of FDA-endorsed and other emerging novel therapeutic strategies.
• Appraise clinical research findings with perioperative anti-PD-1/PD-L1 antibody therapy alone and in combination with antibody-drug conjugate therapy for muscle-invasive bladder cancer (MIBC).
• Develop an understanding of the clinical relevance of circulating tumor DNA (ctDNA) as a prognostic and predictive biomarker for MIBC, and evaluate available research data documenting the benefit of adjuvant anti-PD-1/PD-L1 antibody therapy for patients who are ctDNA positive following cystectomy.
• Appreciate how various clinical and biological factors, including prior therapeutic exposure, affect the selection and sequencing of therapy for patients with metastatic urothelial bladder cancer (UBC).
• Develop a rational approach to the sequencing of systemic therapies for patients with advanced renal cell carcinoma (RCC), incorporating immunotherapeutic agents, multikinase inhibitors, HIF-2α inhibitors or combinations of these approaches.
• Appreciate published clinical research findings evaluating available and investigational agents for non-clear cell RCC, and consider the applicability of these strategies in current clinical care.
• Recall available and emerging data with other novel and investigational agents and strategies currently in testing for prostate cancer, UBC and RCC, and refer eligible patients for clinical trial participation.

ACCREDITATION STATEMENT
Research To Practice is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

CREDIT DESIGNATION STATEMENT
Research To Practice designates this enduring material for a maximum of 1.75 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

AMERICAN BOARD OF INTERNAL MEDICINE (ABIM) — MAINTENANCE OF CERTIFICATION (MOC)
Successful completion of this CME activity, which includes participation in the evaluation component and a post-test, enables the participant to earn up to 1.75 Medical Knowledge MOC points in the American Board of Internal Medicine’s (ABIM) Maintenance of Certification (MOC) program. Participants will earn MOC points equivalent to the amount of CME credits claimed for the activity. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit.

Please note, this program has been specifically designed for the following ABIM specialty: medical oncology.

AMERICAN BOARD OF SURGERY (ABS) — CONTINUOUS CERTIFICATION (CC)
Successful completion of this CME activity, which includes participation in the evaluation component and a post-test, enables the learner to earn credit toward the CME and Self-Assessment requirement(s) of the American Board of Surgery’s Continuous Certification program. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABS credit.

Please note, this program has been specifically designed for the following ABS practice area: complex general surgical oncology.

PRIVACY POLICY
Personal information and data sharing: Research To Practice aggregates deidentified user data for program-use analysis, program development, activity planning and site improvement. We may provide aggregate and deidentified data to third parties, including commercial supporters. We do not share or sell personally identifiable information to any unaffiliated third parties or commercial supporters. Please see our privacy policy at ResearchToPractice.com/Privacy-Policy for more information.

HOW TO USE THIS CME ACTIVITY
To receive credit for this activity, the participant should review the CME information, watch the video, complete the post-test with a score of 80% or better, and fill out the evaluation.

CONTENT VALIDATION AND DISCLOSURES
Research To Practice (RTP) is committed to providing its participants with high-quality, unbiased and state-of-the-art education and adheres to the ACCME’s Standards for Integrity and Independence in Accredited Continuing Education. Any individuals in a position to control the content of an accredited continuing education activity, including faculty, planners, reviewers and others, are required to disclose all relevant financial relationships with ineligible entities (commercial interests). All relevant financial relationships have been mitigated prior to the commencement of this activity. In addition, all activity content is reviewed by RTP scientific staff and an external, independent physician reviewer for fair balance, scientific objectivity of studies referenced and patient care recommendations.

FACULTY — Dr Brody has no relevant financial relationships to disclose. The following faculty reported relevant financial relationships with ineligible entities:

Dr Aggarwal — Advisory Committees: AbbVie Inc, Amgen Inc, Bayer HealthCare Pharmaceuticals, Daiichi Sankyo Inc, Merck, Pfizer Inc; Consulting Agreements: Boxer Capital Management, EcoR1 Capital, Genentech, a member of the Roche Group; Contracted Research: Amgen Inc, AstraZeneca Pharmaceuticals LP, Johnson & Johnson, Merck, Novartis, Zenith Epigenetics; Nonrelevant Financial Relationships: Prostate Cancer Clinical Trials Consortium. Dr Galsky — Contracted Research: Astellas, Merck, Seagen Inc; Travel Support: Pfizer Inc. Dr Zhang — Advisory Committees: Amgen Inc, Arcus Biosciences, AstraZeneca Pharmaceuticals LP, Aveo Pharmaceuticals, Bayer HealthCare Pharmaceuticals, Bristol Myers Squibb, Dendreon Pharmaceuticals Inc, Eisai Inc, EMD Serono Inc, Exelixis Inc, Gilead Sciences Inc, Janssen Biotech Inc, Lilly, Merck, Novartis, Pfizer Inc, Sanofi, Summit Therapeutics, Xencor; Consulting Agreements: Aptitude Health, DAVA Oncology, eChinaHealth, Pfizer Inc, Vaniam Group; Contracted Research: ALX Oncology, Arcus Biosciences, Astellas, AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, Daiichi Sankyo Inc, Exelixis Inc, Janssen Biotech Inc, Janux Therapeutics, Kura Oncology, Lilly, Merck, OncoC4, Pfizer Inc, Tempus; Data and Safety Monitoring Boards/Committees: Novartis; Nonrelevant Financial Relationships: MJH Life Sciences, PeerView.

MODERATOR — Dr Love  is president and CEO of Research To Practice. Research To Practice receives funds in the form of educational grants to develop CME activities from the following companies: Aadi Bioscience, AbbVie Inc, ADC Therapeutics, Agendia Inc, Alexion Pharmaceuticals, Amgen Inc, Array BioPharma Inc, a subsidiary of Pfizer Inc, Arvinas, Astellas, AstraZeneca Pharmaceuticals LP, Aveo Pharmaceuticals, Bayer HealthCare Pharmaceuticals, BeOne, Biotheranostics Inc, A Hologic Company, Black Diamond Therapeutics Inc, Blueprint Medicines, Boehringer Ingelheim Pharmaceuticals Inc, Bristol Myers Squibb, Catalyst Pharmaceuticals Inc, Celcuity, Clovis Oncology, Coherus BioSciences, Corcept Therapeutics Inc, CTI BioPharma, a Sobi Company, Daiichi Sankyo Inc, Eisai Inc, Elevation Oncology Inc, Exact Sciences Corporation, Exelixis Inc, Genentech, a member of the Roche Group, Genmab US Inc, Geron Corporation, Gilead Sciences Inc, GSK, Helsinn Therapeutics (US) Inc, ImmunoGen Inc, Incyte Corporation, Ipsen Biopharmaceuticals Inc, Jazz Pharmaceuticals Inc, Johnson & Johnson, Karyopharm Therapeutics, Kite, A Gilead Company, Kura Oncology, Legend Biotech, Lilly, MEI Pharma Inc, Merck, Mersana Therapeutics Inc, Mirati Therapeutics Inc, Mural Oncology Inc, Natera Inc, Novartis, Novartis Pharmaceuticals Corporation on behalf of Advanced Accelerator Applications, Novocure Inc, Nuvalent, Nuvation Bio Inc, Pfizer Inc, Pharmacyclics LLC, an AbbVie Company, Puma Biotechnology Inc, Regeneron Pharmaceuticals Inc, Revolution Medicines Inc, Rigel Pharmaceuticals Inc, R-Pharm US, Sanofi, Seagen Inc, Servier Pharmaceuticals LLC, SpringWorks Therapeutics Inc, Stemline Therapeutics Inc, Sumitomo Pharma America, Summit Therapeutics, Syndax Pharmaceuticals, Taiho Oncology Inc, Takeda Pharmaceuticals USA Inc, TerSera Therapeutics LLC, Tesaro, A GSK Company, and Verastem Inc.

RESEARCH TO PRACTICE CME PLANNING COMMITTEE MEMBERS, STAFF AND REVIEWERS — Planners, scientific staff and independent reviewers for Research To Practice have no relevant financial relationships to disclose.

This educational activity contains discussion of published and/or investigational uses of agents that are not indicated by the Food and Drug Administration. Research To Practice does not recommend the use of any agent outside of the labeled indications. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications and warnings. The opinions expressed are those of the presenters and are not to be construed as those of the publisher or grantors.

This activity is supported by educational grants from AstraZeneca Pharmaceuticals LP, Exelixis Inc, Johnson & Johnson, and Novartis.

Release date: August 2026
Expiration date: August 2027

Dr Aggarwal
Agarwal N et al. PARP and androgen-signaling inhibition plus ADT in metastatic prostate cancer. N Engl J Med 2026;395(5):427-39. Abstract

Choudhury A et al. A phase 2 trial of androgen deprivation therapy interruption in patients responding exceptionally to androgen receptor pathway inhibitor in metastatic hormone-sensitive prostate cancer (A-DREAM / Alliance A032101). ASCO 2026;Abstract 5004.

Emmett L et al. AcTION: Phase 1 study of [225Ac]Ac-PSMA-617 (225Ac-PSMA-617) in men with metastatic castration-resistant prostate cancer (mCRPC) with or without prior [177Lu]Lu-PSMA (177Lu-PSMA) radioligand therapy (RLT). ASCO 2026;Abstract 5010.

Freedland S et al. EMBARK: Testosterone recovery to >250 ng/dL following treatment suspension. ASCO 2026;Abstract 5088.

Saad F et al. Subgroup analyses by disease volume and de novo/recurrent mHSPC in the PSMAddition study of [177Lu]Lu-PSMA-617. ASCO 2026;Abstract 5020.

Taplin ME et al. Perioperative (neoadjuvant and adjuvant) apalutamide (APA) + androgen deprivation therapy (ADT) vs placebo (PBO) + ADT with radical prostatectomy (RP) in high-risk localized or locally advanced prostate cancer (HR LPC/LAPC): Final analysis of the PROTEUS phase 3 study. ASCO 2026;Abstract LBA1.

Dr Galsky
Bellmunt J et al. Patient-reported outcomes from IMvigor011: A phase 3 study of circulating tumor (ct)DNA–guided adjuvant atezolizumab vs placebo in muscle-invasive bladder cancer (MIBC). ASCO 2026;Abstract 4627.

Daneshmand S et al. TAR-200 for Bacillus Calmette-Guérin-unresponsive high-risk non-muscle-invasive bladder cancer: Results from the phase IIb SunRISe-1 study. J Clin Oncol 2025;43(33):3578-88. Abstract

De Santis M et al. Durvalumab (D) in combination with BCG induction and maintenance (I + M) therapy for BCG-naive, high-risk non-muscle-invasive bladder cancer (NMIBC): 5-year overall survival (OS) analysis and patient-reported outcomes (PROs) from POTOMAC. ASCO 2026;Abstract 4624.

Powles T et al. Enfortumab vedotin plus pembrolizumab vs chemotherapy for previously untreated locally advanced or metastatic urothelial carcinoma: 3.5-year follow-up and response analyses from the phase 3 EV-302 study. ASCO 2026;Abstract 4507.

Powles T et al. ctDNA-guided adjuvant atezolizumab in muscle-invasive bladder cancer. N Engl J Med 2025;393(24):2395-408. Abstract

Vulsteke C et al. Perioperative enfortumab vedotin and pembrolizumab in bladder cancer. N Engl J Med 2026;394(13):1257-69. Abstract

Dr Zhang
Apolo AB et al. Cabozantinib plus nivolumab (C+N) versus sunitinib (S) in patients with advanced renal cell carcinoma (aRCC) and bone metastasis: Updated subgroup analysis of the phase 3 CheckMate-9ER trial. ASCO 2026;Abstract 4528.

Choueiri TK et al. Adjuvant pembrolizumab plus belzutifan versus pembrolizumab for clear cell renal cell carcinoma (ccRCC): The randomized phase 3 LITESPARK-022 study. Genitourinary Cancers Symposium 2026;Abstract LBA418.

Feldman DR et al. Final results of a phase 2 trial of cabozantinib plus nivolumab (CaboNivo) in patients with non–clear cell renal cell carcinoma (nccRCC). ASCO 2026;Abstract 4521.

Larkin J et al. Durvalumab monotherapy versus active monitoring for resected primary renal cell carcinoma in RAMPART: An international, phase 3, randomized controlled trial. ASCO 2026;Abstract LBA4511.

Motzer RJ et al. Belzutifan (bel) plus lenvatinib (lenva) versus cabozantinib (cabo) for advanced renal cell carcinoma (RCC) after anti–PD-(L)1 therapy: Open-label phase 3 LITESPARK-011 study. Genitourinary Cancers Symposium 2026;Abstract LBA417.

Motzer RJ et al. Efficacy outcomes by patterns of progression in patients with advanced renal cell carcinoma from the phase 3 CLEAR trial. ASCO 2026;Abstract 4527.

Faculty

TARGET AUDIENCE
This activity is intended for medical and radiation oncologists, urologists and other healthcare providers involved in the treatment of urothelial bladder cancer.

LEARNING OBJECTIVES

• Analyze the biological basis for the use of perioperative immune checkpoint inhibitor therapy or perioperative immune checkpoint inhibitor therapy in combination with antibody-drug conjugate therapy for patients with muscle-invasive bladder cancer (MIBC), and evaluate available and emerging data documenting the efficacy and safety of these strategies.
• Develop an understanding of the clinical relevance of circulating tumor DNA (ctDNA) as a prognostic and predictive biomarker in MIBC, and evaluate available data documenting the benefit of adjuvant anti-PD-1/PD-L1 antibody therapy for patients with positive ctDNA test results after cystectomy.
• Assess the biological rationale for, available research findings with and potential role of promising investigational agents for NMIBC and MIBC.

ACCREDITATION STATEMENT
Research To Practice is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

CREDIT DESIGNATION STATEMENT
Research To Practice designates this enduring material for a maximum of 0.5 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

PRIVACY POLICY
Personal information and data sharing: Research To Practice aggregates deidentified user data for program-use analysis, program development, activity planning and site improvement. We may provide aggregate and deidentified data to third parties, including commercial supporters. We do not share or sell personally identifiable information to any unaffiliated third parties or commercial supporters. Please see our privacy policy at ResearchToPractice.com/Privacy-Policy for more information.

HOW TO USE THIS CME ACTIVITY
To receive credit for this activity, the participant should review the CME information, watch the video, complete the post-test with a score of 80% or better, and fill out the evaluation.

CONTENT VALIDATION AND DISCLOSURES
Research To Practice (RTP) is committed to providing its participants with high-quality, unbiased and state-of-the-art education and adheres to the ACCME’s Standards for Integrity and Independence in Accredited Continuing Education. Any individuals in a position to control the content of an accredited continuing education activity, including faculty, planners, reviewers and others, are required to disclose all relevant financial relationships with ineligible entities (commercial interests). All relevant financial relationships have been mitigated prior to the commencement of this activity. In addition, all activity content is reviewed by RTP scientific staff and an external, independent physician reviewer for fair balance, scientific objectivity of studies referenced and patient care recommendations.

FACULTY — The following faculty reported relevant financial relationships with ineligible entities:

Dr Galsky — Contracted Research: Astellas, Merck, Seagen Inc; Travel Support: Pfizer Inc. Dr Gupta — Advisory Committees: Bristol Myers Squibb, Merck, Novartis, Pfizer Inc, Tyra Biosciences Inc; Consulting Agreements: Astellas, AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, Bristol Myers Squibb, Convergent Therapeutics Inc, Foundation Medicine, Johnson & Johnson, Merck, Pfizer Inc; Contracted Research: Amgen Inc, Bristol Myers Squibb, Convergent Therapeutics Inc, Flare Therapeutics, Merck, Novartis, Pfizer Inc, Roche Laboratories Inc, Tyra Biosciences Inc; Data and Safety Monitoring Boards/Committees: Protara Therapeutics. Prof Necchi — Advisory Committees: Bristol Myers Squibb, CatalYm, Daiichi Sankyo Inc, Genenta Science, Johnson & Johnson, Merck; Consulting Agreements: AstraZeneca Pharmaceuticals LP, Gilead Sciences Inc, Johnson & Johnson, Merck, Pfizer Inc, Samsung Bioepis; Contracted Research: AstraZeneca Pharmaceuticals LP, Bristol Myers Squibb, Merck.

MODERATOR
Dr Friedlander — Advisory Committees: Aadi Bioscience, AbbVie Inc, Adaptimmune, Aktis Oncology, Astellas, Bicycle Therapeutics, Bristol Myers Squibb, Gilead Sciences Inc, Merck, Pfizer Inc, Samsung Bioepis; Consulting Agreements: Astellas, EMD Serono Inc, Genentech, a member of the Roche Group; Contracted Research: AbbVie Inc, Bicycle Therapeutics, Flare Therapeutics, Genentech, a member of the Roche Group, Johnson & Johnson, Pfizer Inc.

EDITOR — Dr Love is president and CEO of Research To Practice. Research To Practice receives funds in the form of educational grants to develop CME activities from the following companies: Aadi Bioscience, AbbVie Inc, ADC Therapeutics, Agendia Inc, Alexion Pharmaceuticals, Amgen Inc, Array BioPharma Inc, a subsidiary of Pfizer Inc, Arvinas, Astellas, AstraZeneca Pharmaceuticals LP, Aveo Pharmaceuticals, Bayer HealthCare Pharmaceuticals, BeOne, Biotheranostics Inc, A Hologic Company, Black Diamond Therapeutics Inc, Blueprint Medicines, Boehringer Ingelheim Pharmaceuticals Inc, Bristol Myers Squibb, Catalyst Pharmaceuticals Inc, Celcuity, Clovis Oncology, Coherus BioSciences, Corcept Therapeutics Inc, CTI BioPharma, a Sobi Company, Daiichi Sankyo Inc, Eisai Inc, Elevation Oncology Inc, Exact Sciences Corporation, Exelixis Inc, Genentech, a member of the Roche Group, Genmab US Inc, Geron Corporation, Gilead Sciences Inc, GSK, Helsinn Therapeutics (US) Inc, ImmunoGen Inc, Incyte Corporation, Ipsen Biopharmaceuticals Inc, Jazz Pharmaceuticals Inc, Johnson & Johnson, Karyopharm Therapeutics, Kite, A Gilead Company, Kura Oncology, Legend Biotech, Lilly, MEI Pharma Inc, Merck, Mersana Therapeutics Inc, Mirati Therapeutics Inc, Mural Oncology Inc, Natera Inc, Novartis, Novartis Pharmaceuticals Corporation on behalf of Advanced Accelerator Applications, Novocure Inc, Nuvalent, Nuvation Bio Inc, Pfizer Inc, Pharmacyclics LLC, an AbbVie Company, Puma Biotechnology Inc, Regeneron Pharmaceuticals Inc, Revolution Medicines Inc, Rigel Pharmaceuticals Inc, R-Pharm US, Sanofi, Seagen Inc, Servier Pharmaceuticals LLC, SpringWorks Therapeutics Inc, Stemline Therapeutics Inc, Sumitomo Pharma America, Summit Therapeutics, Syndax Pharmaceuticals, Taiho Oncology Inc, Takeda Pharmaceuticals USA Inc, TerSera Therapeutics LLC, Tesaro, A GSK Company, and Verastem Inc.

RESEARCH TO PRACTICE CME PLANNING COMMITTEE MEMBERS, STAFF AND REVIEWERS — Planners, scientific staff and independent reviewers for Research To Practice have no relevant financial relationships to disclose.

This educational activity contains discussion of published and/or investigational uses of agents that are not indicated by the Food and Drug Administration. Research To Practice does not recommend the use of any agent outside of the labeled indications. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications and warnings. The opinions expressed are those of the presenters and are not to be construed as those of the publisher or grantors.

This activity is supported by educational grants from Genentech, a member of the Roche Group, Johnson & Johnson, and Natera Inc.

Release date: August 2026
Expiration date: August 2027

Daneshmand S et al. Erdafitinib in patients with high- and intermediate-risk non–muscle-invasive bladder cancer: Final analysis of THOR-2 study. Eur Urol 2026;89(2):165-73. Abstract

De Santis M et al. Durvalumab (D) in combination with Bacillus Calmette-Guérin (BCG) for BCG-naïve, high-risk non-muscle-invasive bladder cancer (NMIBC): Final analysis of the phase III, open-label, randomised POTOMAC trial. ESMO 2025;Abstract LBA108.

Galsky M et al. Adjuvant nivolumab vs placebo for high-risk muscle-invasive urothelial carcinoma: 5-year efficacy and ctDNA results from CheckMate 274. ESMO 2025;Abstract 3068O.

Galsky MD et al. Adjuvant nivolumab in high-risk muscle-invasive urothelial carcinoma: Expanded efficacy from CheckMate 274. J Clin Oncol 2025;43(1):15-21. Abstract

Galsky MD et al. Adjuvant nivolumab versus placebo for high-risk muscle-invasive urothelial carcinoma: 5-year efficacy and ctDNA results from CheckMate 274. Ann Oncol 2026;37(1):69-78. Abstract

Guerrero-Ramos F et al. Association of molecular markers with clinical response to TAR-200 in the phase IIb SunRISe-1 trial in patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary disease. ESMO 2025;Abstract 3088P.

Guerrero-Ramos F et al. TAR-200 monotherapy in patients with Bacillus Calmette-Guérin–unresponsive papillary disease–only high-risk non–muscle-invasive bladder cancer: First results from cohort 4 of SunRISe-1. AUA 2025;Abstract.

Jacob JM et al. TAR-200 monotherapy in patients with Bacillus Calmette-Guérin–unresponsive high-risk non–muscle-invasive bladder cancer carcinoma in situ: 1-year durability and patient-reported outcomes from SunRISe-1. AUA 2025;Abstract.

Kamat AM et al. Definitions, end points, and clinical trial designs for non-muscle-invasive bladder cancer: Recommendations from the International Bladder Cancer Group. J Clin Oncol 2016;34(16):1935-44. Abstract

Knowles MA, Hurst CD. Molecular biology of bladder cancer: New insights into pathogenesis and clinical diversity. Nat Rev Cancer 2015;15:25-41. Abstract

Li R et al. Bladder-sparing therapy for Bacillus Calmette-Guérin-unresponsive non-muscle-invasive bladder cancer: International Bladder Cancer Group recommendations for optimal sequencing and patient selection. Eur Urol 2024 Dec;86(6):516-27. Abstract

Necchi A et al. Gemcitabine intravesical system (Gem-iDRS) in combination with cetrelimab (CET) versus chemoradiotherapy (CRT) in muscle-invasive bladder cancer (MIBC): SunRISe-2 final results. Genitourinary Cancers Symposium 2026;Abstract 635.

Necchi A et al. Gemcitabine intravesical system plus cetrelimab or cetrelimab alone as neoadjuvant therapy in muscle-invasive bladder cancer: SunRISe-4 primary analysis and biomarker results. J Clin Oncol 2026;44(7):586-97. Abstract

Powles T et al. Circulating tumor DNA (ctDNA) in patients with muscle-invasive bladder cancer (MIBC) who received perioperative durvalumab (D) in NIAGARA. ASCO 2025;Abstract 4503.

Powles T et al. ctDNA-guided adjuvant atezolizumab in muscle-invasive bladder cancer. N Engl J Med 2025;393(24):2395-408. Abstract

Powles T et al. Sasanlimab in combination with bacillus Calmette-Guérin (BCG) in BCG-naive, high-risk non–muscle-invasive bladder cancer (NMIBC): Event-free survival (EFS) subgroup analyses based on disease stage from the CREST study. ASCO 2025;Abstract 4517.

Powles T et al. Enfortumab vedotin and pembrolizumab in untreated advanced urothelial cancer. N Engl J Med 2024;390(10):875-88. Abstract

Powles J et al. Perioperative durvalumab with neoadjuvant chemotherapy in operable bladder cancer. N Engl J Med 2024;391(19):1773-86. Abstract

Powles T et al. A randomized phase III trial of neoadjuvant durvalumab plus chemotherapy followed by radical cystectomy and adjuvant durvalumab in muscle-invasive bladder cancer (NIAGARA). ESMO 2024;Abstract LBA5.

Powles T et al. ctDNA guiding adjuvant immunotherapy in urothelial carcinoma. Nature 2021;595(7867):432-7. Abstract

Roupret M et al. ALBAN: A phase III, randomized, open-label, international study of intravenous (iv) atezolizumab and intravesical Bacillus Calmette-Guérin (BCG) vs BCG alone in BCG-naïve high-risk, non-muscle-invasive bladder cancer (NMIBC). ESMO 2025;Abstract LBA107.

Shore ND et al. Sasanlimab in combination with Bacillus Calmette-Guérin improves event-free survival versus Bacillus Calmette-Guérin as standard of care in high-risk non- muscle-invasive bladder cancer: Phase 3 CREST study results. AUA 2025;Abstract.

Steinberg GD et al. CREST: Phase III study of sasanlimab and Bacillus Calmette-Guérin for patients with Bacillus Calmette-Guérin-naïve high-risk non-muscle-invasive bladder cancer. Future Oncol 2024;20(14):891-901. Abstract

Tyson MD, et al. Pivotal results from BOND-003: A phase 3, single-arm study of intravesical cretostimogene grenadenorepvec for the treatment of high risk, BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ. AUA 2024;Abstract P2-02.

Vilaseca A et al. First safety and efficacy results of the TAR-210 erdafitinib intravesical delivery system in patients with non–muscle-invasive bladder cancer with select FGFR alterations. AUA 2024;Abstract PD48-02.

Vulsteke C et al. Perioperative (periop) enfortumab vedotin (EV) plus pembrolizumab (pembro) in participants (pts) with muscle-invasive bladder cancer (MIBC) who are cisplatin-ineligible: The phase III KEYNOTE-905 study. ESMO 2025;Abstract LBA2.

Vulsteke C et al. Perioperative enfortumab vedotin and pembrolizumab in bladder cancer. N Engl J Med 2026;394:1257-69. Abstract

Wiesen B et al. Updated review on novel therapies and ongoing clinical trials for high-risk non-muscle invasive bladder cancer. Front Oncol 2025;15:1519428. Abstract

Faculty

TARGET AUDIENCE
This activity is intended for medical and radiation oncologists, urologists and other healthcare providers involved in the treatment of urothelial bladder cancer.

LEARNING OBJECTIVES

• Appreciate the biological rationale for combining anti-PD-1/PD-L1 antibodies with bacillus Calmette-Guérin (BCG) for patients with non-muscle-invasive bladder cancer (NMIBC), and discuss available data with and the potential role of this novel approach.
• Optimize the management of high-risk NMIBC that is unresponsive to BCG, considering the efficacy and tolerability of FDA-endorsed therapies.
• Review available clinical trial evidence with novel intravesical therapies for NMIBC, and optimally incorporate these approaches into the care of appropriately selected patients.
• Assess the biological rationale for, available research findings with and potential role of promising investigational agents for NMIBC and MIBC.

ACCREDITATION STATEMENT
Research To Practice is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

CREDIT DESIGNATION STATEMENT
Research To Practice designates this enduring material for a maximum of 0.75 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

PRIVACY POLICY
Personal information and data sharing: Research To Practice aggregates deidentified user data for program-use analysis, program development, activity planning and site improvement. We may provide aggregate and deidentified data to third parties, including commercial supporters. We do not share or sell personally identifiable information to any unaffiliated third parties or commercial supporters. Please see our privacy policy at ResearchToPractice.com/Privacy-Policy for more information.

HOW TO USE THIS CME ACTIVITY
To receive credit for this activity, the participant should review the CME information, watch the video, complete the post-test with a score of 80% or better, and fill out the evaluation.

CONTENT VALIDATION AND DISCLOSURES
Research To Practice (RTP) is committed to providing its participants with high-quality, unbiased and state-of-the-art education and adheres to the ACCME’s Standards for Integrity and Independence in Accredited Continuing Education. Any individuals in a position to control the content of an accredited continuing education activity, including faculty, planners, reviewers and others, are required to disclose all relevant financial relationships with ineligible entities (commercial interests). All relevant financial relationships have been mitigated prior to the commencement of this activity. In addition, all activity content is reviewed by RTP scientific staff and an external, independent physician reviewer for fair balance, scientific objectivity of studies referenced and patient care recommendations.

FACULTY — The following faculty reported relevant financial relationships with ineligible entities:

Dr Galsky — Contracted Research: Astellas, Merck, Seagen Inc; Travel Support: Pfizer Inc. Dr Gupta — Advisory Committees: Bristol Myers Squibb, Merck, Novartis, Pfizer Inc, Tyra Biosciences Inc; Consulting Agreements: Astellas, AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, Bristol Myers Squibb, Convergent Therapeutics Inc, Foundation Medicine, Johnson & Johnson, Merck, Pfizer Inc; Contracted Research: Amgen Inc, Bristol Myers Squibb, Convergent Therapeutics Inc, Flare Therapeutics, Merck, Novartis, Pfizer Inc, Roche Laboratories Inc, Tyra Biosciences Inc; Data and Safety Monitoring Boards/Committees: Protara Therapeutics. Prof Necchi — Advisory Committees: Bristol Myers Squibb, CatalYm, Daiichi Sankyo Inc, Genenta Science, Johnson & Johnson, Merck; Consulting Agreements: AstraZeneca Pharmaceuticals LP, Gilead Sciences Inc, Johnson & Johnson, Merck, Pfizer Inc, Samsung Bioepis; Contracted Research: AstraZeneca Pharmaceuticals LP, Bristol Myers Squibb, Merck.

MODERATOR
Dr Friedlander — Advisory Committees: Aadi Bioscience, AbbVie Inc, Adaptimmune, Aktis Oncology, Astellas, Bicycle Therapeutics, Bristol Myers Squibb, Gilead Sciences Inc, Merck, Pfizer Inc, Samsung Bioepis; Consulting Agreements: Astellas, EMD Serono Inc, Genentech, a member of the Roche Group; Contracted Research: AbbVie Inc, Bicycle Therapeutics, Flare Therapeutics, Genentech, a member of the Roche Group, Johnson & Johnson, Pfizer Inc.

EDITOR — Dr Love is president and CEO of Research To Practice. Research To Practice receives funds in the form of educational grants to develop CME activities from the following companies: Aadi Bioscience, AbbVie Inc, ADC Therapeutics, Agendia Inc, Alexion Pharmaceuticals, Amgen Inc, Array BioPharma Inc, a subsidiary of Pfizer Inc, Arvinas, Astellas, AstraZeneca Pharmaceuticals LP, Aveo Pharmaceuticals, Bayer HealthCare Pharmaceuticals, BeOne, Biotheranostics Inc, A Hologic Company, Black Diamond Therapeutics Inc, Blueprint Medicines, Boehringer Ingelheim Pharmaceuticals Inc, Bristol Myers Squibb, Catalyst Pharmaceuticals Inc, Celcuity, Clovis Oncology, Coherus BioSciences, Corcept Therapeutics Inc, CTI BioPharma, a Sobi Company, Daiichi Sankyo Inc, Eisai Inc, Elevation Oncology Inc, Exact Sciences Corporation, Exelixis Inc, Genentech, a member of the Roche Group, Genmab US Inc, Geron Corporation, Gilead Sciences Inc, GSK, Helsinn Therapeutics (US) Inc, ImmunoGen Inc, Incyte Corporation, Ipsen Biopharmaceuticals Inc, Jazz Pharmaceuticals Inc, Johnson & Johnson, Karyopharm Therapeutics, Kite, A Gilead Company, Kura Oncology, Legend Biotech, Lilly, MEI Pharma Inc, Merck, Mersana Therapeutics Inc, Mirati Therapeutics Inc, Mural Oncology Inc, Natera Inc, Novartis, Novartis Pharmaceuticals Corporation on behalf of Advanced Accelerator Applications, Novocure Inc, Nuvalent, Nuvation Bio Inc, Pfizer Inc, Pharmacyclics LLC, an AbbVie Company, Puma Biotechnology Inc, Regeneron Pharmaceuticals Inc, Revolution Medicines Inc, Rigel Pharmaceuticals Inc, R-Pharm US, Sanofi, Seagen Inc, Servier Pharmaceuticals LLC, SpringWorks Therapeutics Inc, Stemline Therapeutics Inc, Sumitomo Pharma America, Summit Therapeutics, Syndax Pharmaceuticals, Taiho Oncology Inc, Takeda Pharmaceuticals USA Inc, TerSera Therapeutics LLC, Tesaro, A GSK Company, and Verastem Inc.

RESEARCH TO PRACTICE CME PLANNING COMMITTEE MEMBERS, STAFF AND REVIEWERS — Planners, scientific staff and independent reviewers for Research To Practice have no relevant financial relationships to disclose.

This educational activity contains discussion of published and/or investigational uses of agents that are not indicated by the Food and Drug Administration. Research To Practice does not recommend the use of any agent outside of the labeled indications. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications and warnings. The opinions expressed are those of the presenters and are not to be construed as those of the publisher or grantors.

This activity is supported by educational grants from Genentech, a member of the Roche Group, Johnson & Johnson, and Natera Inc.

Release date: August 2026
Expiration date: August 2027

After completing the post-test, learners may download and review the answers here in order to identify further areas of study.

Daneshmand S et al. Erdafitinib in patients with high- and intermediate-risk non–muscle-invasive bladder cancer: Final analysis of THOR-2 study. Eur Urol 2026;89(2):165-73. Abstract

De Santis M et al. Durvalumab (D) in combination with Bacillus Calmette-Guérin (BCG) for BCG-naïve, high-risk non-muscle-invasive bladder cancer (NMIBC): Final analysis of the phase III, open-label, randomised POTOMAC trial. ESMO 2025;Abstract LBA108.

Galsky M et al. Adjuvant nivolumab vs placebo for high-risk muscle-invasive urothelial carcinoma: 5-year efficacy and ctDNA results from CheckMate 274. ESMO 2025;Abstract 3068O.

Galsky MD et al. Adjuvant nivolumab in high-risk muscle-invasive urothelial carcinoma: Expanded efficacy from CheckMate 274. J Clin Oncol 2025;43(1):15-21. Abstract

Galsky MD et al. Adjuvant nivolumab versus placebo for high-risk muscle-invasive urothelial carcinoma: 5-year efficacy and ctDNA results from CheckMate 274. Ann Oncol 2026;37(1):69-78. Abstract

Guerrero-Ramos F et al. Association of molecular markers with clinical response to TAR-200 in the phase IIb SunRISe-1 trial in patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary disease. ESMO 2025;Abstract 3088P.

Guerrero-Ramos F et al. TAR-200 monotherapy in patients with Bacillus Calmette-Guérin–unresponsive papillary disease–only high-risk non–muscle-invasive bladder cancer: First results from cohort 4 of SunRISe-1. AUA 2025;Abstract.

Jacob JM et al. TAR-200 monotherapy in patients with Bacillus Calmette-Guérin–unresponsive high-risk non–muscle-invasive bladder cancer carcinoma in situ: 1-year durability and patient-reported outcomes from SunRISe-1. AUA 2025;Abstract.

Kamat AM et al. Definitions, end points, and clinical trial designs for non-muscle-invasive bladder cancer: Recommendations from the International Bladder Cancer Group. J Clin Oncol 2016;34(16):1935-44. Abstract

Knowles MA, Hurst CD. Molecular biology of bladder cancer: New insights into pathogenesis and clinical diversity. Nat Rev Cancer 2015;15:25-41. Abstract

Li R et al. Bladder-sparing therapy for Bacillus Calmette-Guérin-unresponsive non-muscle-invasive bladder cancer: International Bladder Cancer Group recommendations for optimal sequencing and patient selection. Eur Urol 2024 Dec;86(6):516-27. Abstract

Necchi A et al. Gemcitabine intravesical system (Gem-iDRS) in combination with cetrelimab (CET) versus chemoradiotherapy (CRT) in muscle-invasive bladder cancer (MIBC): SunRISe-2 final results. Genitourinary Cancers Symposium 2026;Abstract 635.

Necchi A et al. Gemcitabine intravesical system plus cetrelimab or cetrelimab alone as neoadjuvant therapy in muscle-invasive bladder cancer: SunRISe-4 primary analysis and biomarker results. J Clin Oncol 2026;44(7):586-97. Abstract

Powles T et al. Circulating tumor DNA (ctDNA) in patients with muscle-invasive bladder cancer (MIBC) who received perioperative durvalumab (D) in NIAGARA. ASCO 2025;Abstract 4503.

Powles T et al. ctDNA-guided adjuvant atezolizumab in muscle-invasive bladder cancer. N Engl J Med 2025;393(24):2395-408. Abstract

Powles T et al. Sasanlimab in combination with bacillus Calmette-Guérin (BCG) in BCG-naive, high-risk non–muscle-invasive bladder cancer (NMIBC): Event-free survival (EFS) subgroup analyses based on disease stage from the CREST study. ASCO 2025;Abstract 4517.

Powles T et al. Enfortumab vedotin and pembrolizumab in untreated advanced urothelial cancer. N Engl J Med 2024;390(10):875-88. Abstract

Powles J et al. Perioperative durvalumab with neoadjuvant chemotherapy in operable bladder cancer. N Engl J Med 2024;391(19):1773-86. Abstract

Powles T et al. A randomized phase III trial of neoadjuvant durvalumab plus chemotherapy followed by radical cystectomy and adjuvant durvalumab in muscle-invasive bladder cancer (NIAGARA). ESMO 2024;Abstract LBA5.

Powles T et al. ctDNA guiding adjuvant immunotherapy in urothelial carcinoma. Nature 2021;595(7867):432-7. Abstract

Roupret M et al. ALBAN: A phase III, randomized, open-label, international study of intravenous (iv) atezolizumab and intravesical Bacillus Calmette-Guérin (BCG) vs BCG alone in BCG-naïve high-risk, non-muscle-invasive bladder cancer (NMIBC). ESMO 2025;Abstract LBA107.

Shore ND et al. Sasanlimab in combination with Bacillus Calmette-Guérin improves event-free survival versus Bacillus Calmette-Guérin as standard of care in high-risk non- muscle-invasive bladder cancer: Phase 3 CREST study results. AUA 2025;Abstract.

Steinberg GD et al. CREST: Phase III study of sasanlimab and Bacillus Calmette-Guérin for patients with Bacillus Calmette-Guérin-naïve high-risk non-muscle-invasive bladder cancer. Future Oncol 2024;20(14):891-901. Abstract

Tyson MD, et al. Pivotal results from BOND-003: A phase 3, single-arm study of intravesical cretostimogene grenadenorepvec for the treatment of high risk, BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ. AUA 2024;Abstract P2-02.

Vilaseca A et al. First safety and efficacy results of the TAR-210 erdafitinib intravesical delivery system in patients with non–muscle-invasive bladder cancer with select FGFR alterations. AUA 2024;Abstract PD48-02.

Vulsteke C et al. Perioperative (periop) enfortumab vedotin (EV) plus pembrolizumab (pembro) in participants (pts) with muscle-invasive bladder cancer (MIBC) who are cisplatin-ineligible: The phase III KEYNOTE-905 study. ESMO 2025;Abstract LBA2.

Vulsteke C et al. Perioperative enfortumab vedotin and pembrolizumab in bladder cancer. N Engl J Med 2026;394:1257-69. Abstract

Wiesen B et al. Updated review on novel therapies and ongoing clinical trials for high-risk non-muscle invasive bladder cancer. Front Oncol 2025;15:1519428. Abstract

Faculty

TARGET AUDIENCE
This program is intended for medical and radiation oncologists, urologists and other healthcare providers involved in the treatment of urothelial bladder cancer.

LEARNING OBJECTIVES

• Appreciate the biological rationale for combining anti-PD-1/PD-L1 antibodies with bacillus Calmette-Guérin (BCG) for patients with non-muscle-invasive bladder cancer (NMIBC), and discuss available data with and the potential role of this novel approach.
• Optimize the management of high-risk NMIBC that is unresponsive to BCG, considering the efficacy and tolerability of FDA-endorsed therapies.
• Review available clinical trial evidence with novel intravesical therapies for NMIBC, and optimally incorporate these approaches into the care of appropriately selected patients.
• Analyze the biological basis for the use of perioperative immune checkpoint inhibitor therapy or perioperative immune checkpoint inhibitor therapy in combination with antibody-drug conjugate therapy for patients with muscle-invasive bladder cancer (MIBC), and evaluate available and emerging data documenting the efficacy and safety of these strategies.
• Develop an understanding of the clinical relevance of circulating tumor DNA (ctDNA) as a prognostic and predictive biomarker in MIBC, and evaluate available data documenting the benefit of adjuvant anti-PD-1/PD-L1 antibody therapy for patients with positive ctDNA test results after cystectomy.
• Assess the biological rationale for, available research findings with and potential role of promising investigational agents for NMIBC and MIBC.

ACCREDITATION STATEMENT
Research To Practice is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

CREDIT DESIGNATION STATEMENT

Video Interview: Research To Practice designates this enduring material for a maximum of 2.25 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

AMERICAN BOARD OF INTERNAL MEDICINE (ABIM) — MAINTENANCE OF CERTIFICATION (MOC)
Successful completion of these CME activities, which includes participation in the evaluation components and post-tests, enables the participant to earn up to 2.25 (video) Medical Knowledge MOC points in the American Board of Internal Medicine’s (ABIM) Maintenance of Certification (MOC) program. Participants will earn MOC points equivalent to the amount of CME credits claimed for each activity. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit.

Please note, these programs have been specifically designed for the following ABIM specialty: medical oncology.

AMERICAN BOARD OF SURGERY (ABS) — CONTINUOUS CERTIFICATION (CC)
Successful completion of these CME activities, which includes participation in the evaluation components and post-tests, enables the learner to earn credit toward the CME and Self-Assessment requirement(s) of the American Board of Surgery’s Continuous Certification program. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABS credit.

Please note, these programs have been specifically designed for the following ABS practice area: complex general surgical oncology.

PRIVACY POLICY
Personal information and data sharing: Research To Practice aggregates deidentified user data for program-use analysis, program development, activity planning and site improvement. We may provide aggregate and deidentified data to third parties, including commercial supporters. We do not share or sell personally identifiable information to any unaffiliated third parties or commercial supporters. Please see our privacy policy at ResearchToPractice.com/Privacy-Policy for more information.

HOW TO USE THIS CME ACTIVITY
Video Program: This CME activity consists of a video component. To receive credit, the participant should review the CME information, watch the video, complete the post-test with a score of 80% or better and fill out the evaluation located at ResearchToPractice.com/ASCOGU2026/nmBladder/Video/CME.

CONTENT VALIDATION AND DISCLOSURES
Research To Practice (RTP) is committed to providing its participants with high-quality, unbiased and state-of-the-art education and adheres to the ACCME’s Standards for Integrity and Independence in Accredited Continuing Education. Any individuals in a position to control the content of an accredited continuing education activity, including faculty, planners, reviewers and others, are required to disclose all relevant financial relationships with ineligible entities (commercial interests). All relevant financial relationships have been mitigated prior to the commencement of this activity. In addition, all activity content is reviewed by RTP scientific staff and an external, independent physician reviewer for fair balance, scientific objectivity of studies referenced and patient care recommendations.

FACULTY — The following faculty reported relevant financial relationships with ineligible entities:

Matthew D Galsky, MD
Lillian and Howard Stratton Professor of Medicine
Icahn School of Medicine at Mount Sinai
Co-Leader, Bladder Cancer Center of Excellence
Associate Director, Translational Research
The Tisch Cancer Institute
New York, New York

Consulting Agreements: AbbVie Inc, AstraZeneca Pharmaceuticals LP, EMD Serono Inc, Gilead Sciences Inc, Janssen Biotech Inc, Merck, Pfizer Inc, Seagen Inc.

Shilpa Gupta, MD
Professor of Medicine
Cleveland Clinic Lerner College of Medicine at Case Western Reserve University
Director, Genitourinary Oncology Program
Taussig Cancer Institute, Cleveland Clinic
Cleveland, Ohio

Advisory Committees: Bristol Myers Squibb, Merck, Novartis, Pfizer Inc, Tyra Biosciences Inc; Consulting Agreements: Astellas, AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, Bristol Myers Squibb, Convergent Therapeutics Inc, Foundation Medicine, Johnson & Johnson, Merck, Pfizer Inc; Contracted Research: Amgen Inc, Bristol Myers Squibb, Convergent Therapeutics Inc, Flare Therapeutics, Merck, Novartis, Pfizer Inc, Roche Laboratories Inc, Tyra Biosciences Inc; Data and Safety Monitoring Boards/Committees: Protara Therapeutics.

Andrea Necchi, MD
Associate Professor
Vita-Salute San Raffaele University
Head of Genitourinary Medical Oncology
IRCCS San Raffaele Hospital
Milan, Italy

Advisory Committees: Bristol Myers Squibb, CatalYm, Daiichi Sankyo Inc, Genenta Science, Johnson & Johnson, Merck; Consulting Agreements: AstraZeneca Pharmaceuticals LP, Gilead Sciences Inc, Johnson & Johnson, Merck, Pfizer Inc, Samsung Bioepis; Contracted Research: AstraZeneca Pharmaceuticals LP, Bristol Myers Squibb, Merck.

CONSULTING CLINICAL INVESTIGATORS — Elizabeth R Plimack, MD, MS — Advisory Committees: 23andMe, Adaptimmune, Astellas, Bristol Myers Squibb, Cyana Therapeutics, Daiichi Sankyo Inc, Domain Therapeutics, Eisai Inc, enGene, Flatiron Health, Johnson & Johnson, Merck, Natera Inc, Ottimo Pharma, Pfizer Inc, UroGen Pharma; Contracted Research: Bristol Myers Squibb, Merck. Thomas Powles, MBBS, MRCP, MD — Advisory Committees and Consulting Agreements: Astellas, AstraZeneca Pharmaceuticals LP, Bristol Myers Squibb, Eisai Inc, Exelixis Inc, Incyte Corporation, Ipsen Biopharmaceuticals Inc, Johnson & Johnson, Merck Serono, MSD, Novartis, Pfizer Inc, Roche Laboratories inc, Seagen Inc; Nonrelevant Financial Relationships: Mashup Media LLC.

MODERATOR
Terence Friedlander, MD
Professor of Medicine and Robert and Virginia O’Reilly Family Endowed Chair
Chief, Division of Hematology/Oncology
Zuckerberg San Francisco General Hospital
Helen Diller Family Comprehensive Cancer Center
University of California, San Francisco
San Francisco, California

Advisory Committees: Aadi Bioscience, AbbVie Inc, Adaptimmune, Aktis Oncology, Astellas, Bicycle Therapeutics, Bristol Myers Squibb, Gilead Sciences Inc, Merck, Pfizer Inc, Samsung Bioepis; Consulting Agreements: Astellas, EMD Serono Inc, Genentech, a member of the Roche Group; Contracted Research: AbbVie Inc, Bicycle Therapeutics, Flare Therapeutics, Genentech, a member of the Roche Group, Johnson & Johnson, Pfizer Inc.

RESEARCH TO PRACTICE CME PLANNING COMMITTEE MEMBERS, STAFF AND REVIEWERS — Planners, scientific staff and independent reviewers for Research To Practice have no relevant financial relationships to disclose.

These educational activities contain discussion of published and/or investigational uses of agents that are not indicated by the Food and Drug Administration. Research To Practice does not recommend the use of any agent outside of the labeled indications. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications and warnings. The opinions expressed are those of the presenters and are not to be construed as those of the publisher or grantors.

These activities are supported by educational grants from Genentech, a member of the Roche Group, Johnson & Johnson, and Natera Inc.

Release date: March 2026
Expiration date: March 2027

After completing the post-test, learners may download and review the answers here in order to identify further areas of study.

Dr Friedlander

De Santis M et al. Durvalumab (D) in combination with bacillus Calmette-Guérin (BCG) for BCG-naïve, high-risk non-muscle-invasive bladder cancer (NMIBC): Final analysis of the phase III, open-label, randomised POTOMAC trial. ESMO 2025;Abstract LBA108.

Li R et al. Bladder-sparing therapy for bacillus Calmette-Guérin-unresponsive non-muscle-invasive bladder cancer: International Bladder Cancer Group recommendations for optimal sequencing and patient selection. Eur Urol 2024;86(6):516-27. Abstract

Powles T et al. Sasanlimab in combination with bacillus Calmette-Guérin (BCG) in BCG-naive, high-risk non–muscle-invasive bladder cancer (NMIBC): Event-free survival (EFS) subgroup analyses based on disease stage from the CREST study. ASCO 2025;Abstract 4517.

Roupret M et al. ALBAN: A phase III, randomized, open-label, international study of intravenous (iv) atezolizumab and intravesical bacillus Calmette-Guérin (BCG) vs BCG alone in BCG-naïve high-risk, non-muscle-invasive bladder cancer (NMIBC). ESMO 2025;Abstract LBA107.

Shore ND et al. Sasanlimab in combination with bacillus Calmette-Guérin improves event-free survival versus bacillus Calmette-Guérin as standard of care in high-risk non-muscle-invasive bladder cancer: Phase 3 CREST study results. J Urol 2025;213(5S2):e1. Abstract

Steinberg GD et al. CREST: Phase III study of sasanlimab and bacillus Calmette-Guérin for patients with bacillus Calmette-Guérin-naïve high-risk non-muscle-invasive bladder cancer. Future Oncol 2024;20(14):891-901. Abstract

Wiesen B et al. Updated review on novel therapies and ongoing clinical trials for high-risk non-muscle invasive bladder cancer. Front Oncol 2025:15:1519428. Abstract

Dr Gupta

Galsky MD et al. Adjuvant nivolumab vs placebo for high-risk muscle-invasive urothelial carcinoma: 5-year efficacy and ctDNA results from CheckMate 274. ESMO 2025;Abstract 3068O.

Powles TB et al. A randomized phase III trial of neoadjuvant durvalumab plus chemotherapy followed by radical cystectomy and adjuvant durvalumab in muscle-invasive bladder cancer (NIAGARA). ESMO 2024;Abstract LBA5.

Powles T et al. Enfortumab vedotin and pembrolizumab in untreated advanced urothelial cancer. N Engl J Med 2024;390(10):875-88. Abstract

Vulsteke C et al. Perioperative enfortumab vedotin and pembrolizumab in bladder cancer. N Engl J Med 2026;[Online ahead of print]. Abstract

Vulsteke C et al. Perioperative (periop) enfortumab vedotin (EV) plus pembrolizumab (pembro) in participants (pts) with muscle-invasive bladder cancer (MIBC) who are cisplatin-ineligible: The phase III KEYNOTE-905 study. ESMO 2025;Abstract LBA2.

Prof Necchi

Daneshmand S et al. Erdafitinib in patients with high- and intermediate-risk non–muscle-invasive bladder cancer: Final analysis of THOR-2 study. Eur Urol 2026;89(2):165-73. Abstract

Guerrero-Ramos F et al. Association of molecular markers with clinical response to TAR-200 in the phase IIb SunRISe-1 trial in patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary disease. ESMO 2025;Abstract 3088P.

Guerrero-Ramos F et al. TAR-200 monotherapy in patients with bacillus Calmette-Guérin–unresponsive papillary disease–only high-risk non–muscle-invasive bladder cancer: First results from cohort 4 of SunRISe-1. J Urol 2025;213(5S2):e2. Abstract

Jacob JM et al. TAR-200 monotherapy in patients with bacillus Calmette-Guérin–unresponsive high-risk non–muscle-invasive bladder cancer carcinoma in situ: 1-year durability and patient-reported outcomes from SunRISe-1. 2025;213(5S2):e2. Abstract

Kamat AM et al. Definitions, end points, and clinical trial designs for non-muscle-invasive bladder cancer: Recommendations from the International Bladder Cancer Group. J Clin Oncol 2016;34(16):1935-44. Abstract

Knowles MA, Hurst CD. Molecular biology of bladder cancer: New insights into pathogenesis and clinical diversity. Nat Rev Cancer 2015;15:25-41. Abstract

Necchi A et al. Gemcitabine intravesical system (Gem-iDRS) in combination with cetrelimab (CET) versus chemoradiotherapy (CRT) in muscle-invasive bladder cancer (MIBC): SunRISe-2 final results. Genitourinary Cancers Symposium 2026;Abstract 635.

Necchi A et al. Gemcitabine intravesical system plus cetrelimab or cetrelimab alone as neoadjuvant therapy in muscle-invasive bladder cancer: SunRISe-4 primary analysis and biomarker results. J Clin Oncol 2026;44(7):586-97. Abstract

Tyson MD et al. Pivotal results from BOND-003: A phase 3, single-arm study of intravesical cretostimogene grenadenorepvec for the treatment of high risk, BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ. J Urol 2024;211(5S2):e1. Abstract

Vilaseca A et al. First safety and efficacy results of the TAR-210 erdafitinib intravesical delivery system in patients with non–muscle-invasive bladder cancer with select FGFR alterations. J Urol 2024;211(5S):e987. Abstract

Dr Galsky

Galsky MD et al. Adjuvant nivolumab versus placebo for high-risk muscle-invasive urothelial carcinoma: 5-year efficacy and ctDNA results from CheckMate 274. Ann Oncol 2026;37(1):69-78. Abstract

Galsky MD et al. Adjuvant nivolumab in high-risk muscle-invasive urothelial carcinoma: Expanded efficacy from CheckMate 274. J Clin Oncol 2025;43(1):15-21. Abstract

Powles T et al. Circulating tumor DNA (ctDNA) in patients with muscle-invasive bladder cancer (MIBC) who received perioperative durvalumab (D) in NIAGARA. ASCO 2025;Abstract 4503.

Powles T et al. ctDNA-guided adjuvant atezolizumab in muscle-invasive bladder cancer. N Engl J Med 2025;393(24):2395-408. Abstract

Powles T et al. Perioperative durvalumab with neoadjuvant chemotherapy in operable bladder cancer. N Engl J Med 2024;391(19):1773-86. Abstract

Powles T et al. ctDNA guiding adjuvant immunotherapy in urothelial carcinoma. Nature 2021;595(7867):432-7. Abstract

Faculty

TARGET AUDIENCE
This activity is intended for medical oncologists, hematology-oncology fellows and other healthcare providers involved in the treatment of metastatic urothelial bladder cancer.

LEARNING OBJECTIVES

• Review how biological factors and patient characteristics such as age, performance status, prior treatment, comorbidities and preexisting conditions influence the selection and sequencing of treatment for metastatic urothelial bladder cancer (mUBC).
• Recognize the incidence of nectin-4 expression in patients with UBC, and appreciate the scientific justification for the development of antibody-drug conjugates (ADCs) targeting this novel biomarker.
• Interrogate published efficacy and safety findings with anti-PD-1/PD-L1 antibodies in combination with ADC therapy as first-line treatment for mUBC, and consider the current role of this strategy in patient care.
• Recall pivotal clinical trial findings leading to the FDA approval of novel compounds with unique mechanisms of action for previously treated locally advanced or metastatic UBC, such as ADCs and tyrosine kinase inhibitors, and identify patients for whom these approaches would be appropriate.
• Appreciate the frequency and severity of therapy-related adverse events commonly encountered by patients receiving guideline-endorsed agents and regimens for mUBC, and enact effective monitoring and management procedures.
• Describe the scientific justification for and published research data with novel strategies under investigation in UBC, and effectively prioritize clinical trial opportunities for eligible patients.

ACCREDITATION STATEMENT
Research To Practice is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

CREDIT DESIGNATION STATEMENT
Video Program: Research To Practice designates this enduring material for a maximum of 0.75 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

AMERICAN BOARD OF INTERNAL MEDICINE (ABIM) — MAINTENANCE OF CERTIFICATION (MOC)
Successful completion of these CME activities, which includes participation in the evaluation components and post-tests, enables the participant to earn up to 0.75 (video) Medical Knowledge MOC points in the American Board of Internal Medicine’s (ABIM) Maintenance of Certification (MOC) program. Participants will earn MOC points equivalent to the amount of CME credits claimed for each activity. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit.

Please note, these programs have been specifically designed for the following ABIM specialty: medical oncology.

AMERICAN BOARD OF SURGERY (ABS) — CONTINUOUS CERTIFICATION (CC)
Successful completion of these CME activities, which includes participation in the evaluation components and post-tests, enables the learner to earn credit toward the CME and Self-Assessment requirement(s) of the American Board of Surgery’s Continuous Certification program. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABS credit.

Please note, these programs have been specifically designed for the following ABS practice area: complex general surgical oncology.

PRIVACY POLICY
Personal information and data sharing: Research To Practice aggregates deidentified user data for program-use analysis, program development, activity planning and site improvement. We may provide aggregate and deidentified data to third parties, including commercial supporters. We do not share or sell personally identifiable information to any unaffiliated third parties or commercial supporters. Please see our privacy policy at ResearchToPractice.com/Privacy-Policy for more information.

HOW TO USE THIS CME ACTIVITY
Video Program: This CME activity consists of a video component. To receive credit, the participant should review the CME information, watch the video, complete the post-test with a score of 80% or better and fill out the evaluation located at ResearchToPractice.com/RapidCaseReview2026/Bladder/2/Video/CME.

CONTENT VALIDATION AND DISCLOSURES
Research To Practice (RTP) is committed to providing its participants with high-quality, unbiased and state-of-the-art education and adheres to the ACCME’s Standards for Integrity and Independence in Accredited Continuing Education. Any individuals in a position to control the content of an accredited continuing education activity, including faculty, planners, reviewers and others, are required to disclose all relevant financial relationships with ineligible entities (commercial interests). All relevant financial relationships have been mitigated prior to the commencement of these activities. In addition, all activity content is reviewed by RTP scientific staff and an external, independent physician reviewer for fair balance, scientific objectivity of studies referenced and patient care recommendations.

FACULTY

Fern Anari, MD
Assistant Professor of Genitourinary Medical Oncology
Fox Chase Cancer Center
Philadelphia, Pennsylvania

Catherine Fahey, MD, PhD
Assistant Professor, Division of Oncology
Department of Medicine
Lineberger Comprehensive Cancer Center
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina

The following faculty reported relevant financial relationships with ineligible entities:

Matthew D Galsky, MD
Lillian and Howard Stratton Professor of Medicine
Icahn School of Medicine at Mount Sinai
Co-Leader, Bladder Cancer Center of Excellence
Associate Director, Translational Research
The Tisch Cancer Institute
New York, New York

Consulting Agreements: AbbVie Inc, AstraZeneca Pharmaceuticals LP, EMD Serono Inc, Gilead Sciences Inc, Janssen Biotech Inc, Merck, Pfizer Inc, Seagen Inc.

EDITOR — Dr Love is president and CEO of Research To Practice. Research To Practice receives funds in the form of educational grants to develop CME activities from the following companies: Aadi Bioscience, AbbVie Inc, ADC Therapeutics, Agendia Inc, Alexion Pharmaceuticals, Amgen Inc, Array BioPharma Inc, a subsidiary of Pfizer Inc, Arvinas, Astellas, AstraZeneca Pharmaceuticals LP, Aveo Pharmaceuticals, Bayer HealthCare Pharmaceuticals, BeOne, Biotheranostics Inc, A Hologic Company, Black Diamond Therapeutics Inc, Blueprint Medicines, Boehringer Ingelheim Pharmaceuticals Inc, Bristol Myers Squibb, Celcuity, Clovis Oncology, Coherus BioSciences, Corcept Therapeutics Inc, CTI BioPharma, a Sobi Company, Daiichi Sankyo Inc, Eisai Inc, Elevation Oncology Inc, Exact Sciences Corporation, Exelixis Inc, Genentech, a member of the Roche Group, Genmab US Inc, Geron Corporation, Gilead Sciences Inc, GSK, Helsinn Therapeutics (US) Inc, ImmunoGen Inc, Incyte Corporation, Ipsen Biopharmaceuticals Inc, Jazz Pharmaceuticals Inc, Johnson & Johnson, Karyopharm Therapeutics, Kite, A Gilead Company, Kura Oncology, Legend Biotech, Lilly, MEI Pharma Inc, Merck, Mersana Therapeutics Inc, Mirati Therapeutics Inc, Mural Oncology Inc, Natera Inc, Novartis, Novartis Pharmaceuticals Corporation on behalf of Advanced Accelerator Applications, Novocure Inc, Nuvalent, Nuvation Bio Inc, Pfizer Inc, Pharmacyclics LLC, an AbbVie Company, Puma Biotechnology Inc, Regeneron Pharmaceuticals Inc, Revolution Medicines Inc, Rigel Pharmaceuticals Inc, R-Pharm US, Sanofi, Seagen Inc, Servier Pharmaceuticals LLC, SpringWorks Therapeutics Inc, Stemline Therapeutics Inc, Sumitomo Pharma America, Syndax Pharmaceuticals, Taiho Oncology Inc, Takeda Pharmaceuticals USA Inc, TerSera Therapeutics LLC, and Tesaro, A GSK Company.

RESEARCH TO PRACTICE CME PLANNING COMMITTEE MEMBERS, STAFF AND REVIEWERS — Planners, scientific staff and independent reviewers for Research To Practice have no relevant financial relationships to disclose.

These educational activities contain discussion of published and/or investigational uses of agents that are not indicated by the Food and Drug Administration. Research To Practice does not recommend the use of any agent outside of the labeled indications. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications and warnings. The opinions expressed are those of the presenters and are not to be construed as those of the publisher or grantor.

These activities are supported by an educational grant from Astellas and Pfizer Inc.

Release date: February 2026
Expiration date: February 2027

After completing the post-test, learners may download and review the answers here in order to identify further areas of study.

De Santis M et al. Durvalumab (D) in combination with bacillus Calmette-Guérin (BCG) for BCG-naïve, high-risk non-muscle-invasive bladder cancer (NMIBC): Final analysis of the phase III, open-label, randomised POTOMAC trial. ESMO 2025;Abstract LBA108.

Galsky MD et al. Adjuvant nivolumab vs placebo for high-risk muscle-invasive urothelial carcinoma: 5-year efficacy and ctDNA results from CheckMate 274. ESMO 2025;Abstract 3068O. 

Makker V et al. Trastuzumab deruxtecan (T-DXd) for pretreated patients (pts) with HER2-expressing solid tumors: DESTINY-PanTumor02 (DP-02) part 1 final analysis. ESMO 2025;Abstract 957P.

Necchi A et al. Neoadjuvant gemcitabine intravesical system (TAR-200) + cetrelimab (CET) or CET alone in patients (pts) with muscle-invasive bladder cancer (MIBC): SunRISe-4 (SR-4) primary analysis and biomarker results. ESMO 2025;Abstract LBA112.

Powles TB et al. IMvigor011: A phase III trial of circulating tumour (ct)DNA-guided adjuvant atezolizumab vs placebo in muscle-invasive bladder cancer. ESMO 2025;Abstract LBA8.

Rha SY et al. Datopotamab deruxtecan (Dato-DXd) + rilvegostomig (rilve) in patients (pts) with locally advanced or metastatic urothelial cancer (a/mUC): Results from the phase II TROPION-PanTumor03 study. ESMO 2025;Abstract 3072MO.

Sheng X et al. Disitamab vedotin (DV) plus toripalimab (T) versus chemotherapy (C) in first-line (1L) locally advanced or metastatic urothelial carcinoma (la/mUC) with HER2-expression. ESMO 2025;Abstract LBA7.

van der Heijden MS et al. Health-related quality of life (HRQoL) outcomes from the NIAGARA trial of perioperative durvalumab (D) plus neoadjuvant chemotherapy (NAC) in muscle-invasive bladder cancer (MIBC). ESMO 2025;Abstract 3069MO.

Vulsteke C et al. Perioperative (periop) enfortumab vedotin (EV) plus pembrolizumab (pembro) in participants (pts) with muscle-invasive bladder cancer (MIBC) who are cisplatin-ineligible: The phase III KEYNOTE-905 study. ESMO 2025;Abstract LBA2.

Faculty

TARGET AUDIENCE
This activity is intended for medical oncologists, hematology-oncology fellows and other healthcare providers involved in the treatment of metastatic bladder cancer.

LEARNING OBJECTIVES

• Review how biological and patient-specific factors (eg, age, performance status, prior treatment, comorbidities and preexisting conditions) influence the selection and sequencing of treatment for metastatic urothelial bladder cancer (mUBC).
• Recognize the incidence of nectin-4 expression in patients with UBC, and appreciate the scientific justification for the development of antibody-drug conjugates (ADCs) targeting this novel biomarker.
• Interrogate published efficacy and safety findings with anti-PD-1/PD-L1 antibodies in combination with ADC therapy as first-line treatment for mUBC, and consider the current role of this strategy for patients with the disease.
• Recall pivotal clinical trial findings leading to the FDA approval of novel compounds (eg, ADCs, tyrosine kinase inhibitors) with unique mechanisms of action for previously treated locally advanced or mUBC, and identify patients for whom these approaches would be appropriate.
• Appreciate the frequency and severity of therapy-related adverse events commonly encountered by patients receiving guideline-endorsed agents and regimens for mUBC, and enact effective monitoring and management procedures for appropriate individuals.
• Describe the scientific justification for and published research data with novel strategies under investigation in UBC, and effectively prioritize clinical trial opportunities for eligible patients.

ACCREDITATION STATEMENT
Research To Practice is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

CREDIT DESIGNATION STATEMENT
Video Program: Research To Practice designates this enduring material for a maximum of 0.75 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

AMERICAN BOARD OF INTERNAL MEDICINE (ABIM) — MAINTENANCE OF CERTIFICATION (MOC)
Successful completion of these CME activities, which includes participation in the evaluation components and post-tests, enables the participant to earn up to 0.75 (video) Medical Knowledge MOC points in the American Board of Internal Medicine’s (ABIM) Maintenance of Certification (MOC) program. Participants will earn MOC points equivalent to the amount of CME credits claimed for each activity. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit.

Please note, these programs have been specifically designed for the following ABIM specialty: medical oncology.

AMERICAN BOARD OF SURGERY (ABS) — CONTINUOUS CERTIFICATION (CC)
Successful completion of these CME activities, which includes participation in the evaluation components and post-tests, enables the learner to earn credit toward the CME and Self-Assessment requirement(s) of the American Board of Surgery’s Continuous Certification program. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABS credit.

Please note, these programs have been specifically designed for the following ABS practice area: complex general surgical oncology.

PRIVACY POLICY
Personal information and data sharing: Research To Practice aggregates deidentified user data for program-use analysis, program development, activity planning and site improvement. We may provide aggregate and deidentified data to third parties, including commercial supporters. We do not share or sell personally identifiable information to any unaffiliated third parties or commercial supporters. Please see our privacy policy at ResearchToPractice.com/Privacy-Policy for more information.

HOW TO USE THIS CME ACTIVITY
To receive credit for an activity in this series, the participant should review the CME information, listen to or view the MP3s, complete the post-test with a score of 80% or better and fill out the evaluation. Program location URLs are noted below:

Video Interview: ResearchToPractice.com/RapidCaseReview2026/Bladder/1/Video and evaluation ResearchToPractice.com/RapidCaseReview2026/Bladder/1/Video/CME.

CONTENT VALIDATION AND DISCLOSURES
Research To Practice (RTP) is committed to providing its participants with high-quality, unbiased and state-of-the-art education and adheres to the ACCME’s Standards for Integrity and Independence in Accredited Continuing Education. Any individuals in a position to control the content of an accredited continuing education activity, including faculty, planners, reviewers and others, are required to disclose all relevant financial relationships with ineligible entities (commercial interests). All relevant financial relationships have been mitigated prior to the commencement of these activities. In addition, all activity content is reviewed by RTP scientific staff and an external, independent physician reviewer for fair balance, scientific objectivity of studies referenced and patient care recommendations.

FACULTY

Fern Anari, MD
Assistant Professor of Genitourinary Medical Oncology
Fox Chase Cancer Center
Philadelphia, Pennsylvania

Catherine Fahey, MD, PhD
Assistant Professor, Division of Oncology
Department of Medicine
Lineberger Comprehensive Cancer Center
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina

The following faculty reported relevant financial relationships with ineligible entities:

Matthew D Galsky, MD
Lillian and Howard Stratton Professor of Medicine
Icahn School of Medicine at Mount Sinai
Co-Leader, Bladder Cancer Center of Excellence
Associate Director, Translational Research
The Tisch Cancer Institute
New York, New York

Consulting Agreements: AbbVie Inc, AstraZeneca Pharmaceuticals LP, EMD Serono Inc, Gilead Sciences Inc, Janssen Biotech Inc, Merck, Pfizer Inc, Seagen Inc.

EDITOR — Dr Love is president and CEO of Research To Practice. Research To Practice receives funds in the form of educational grants to develop CME activities from the following companies: Aadi Bioscience, AbbVie Inc, ADC Therapeutics, Agendia Inc, Alexion Pharmaceuticals, Amgen Inc, Array BioPharma Inc, a subsidiary of Pfizer Inc, Arvinas, Astellas, AstraZeneca Pharmaceuticals LP, Aveo Pharmaceuticals, Bayer HealthCare Pharmaceuticals, BeOne, Biotheranostics Inc, A Hologic Company, Black Diamond Therapeutics Inc, Blueprint Medicines, Boehringer Ingelheim Pharmaceuticals Inc, Bristol Myers Squibb, Celcuity, Clovis Oncology, Coherus BioSciences, Corcept Therapeutics Inc, CTI BioPharma, a Sobi Company, Daiichi Sankyo Inc, Eisai Inc, Elevation Oncology Inc, Exact Sciences Corporation, Exelixis Inc, Genentech, a member of the Roche Group, Genmab US Inc, Geron Corporation, Gilead Sciences Inc, GSK, Helsinn Therapeutics (US) Inc, ImmunoGen Inc, Incyte Corporation, Ipsen Biopharmaceuticals Inc, Jazz Pharmaceuticals Inc, Johnson & Johnson, Karyopharm Therapeutics, Kite, A Gilead Company, Kura Oncology, Legend Biotech, Lilly, MEI Pharma Inc, Merck, Mersana Therapeutics Inc, Mirati Therapeutics Inc, Mural Oncology Inc, Natera Inc, Novartis, Novartis Pharmaceuticals Corporation on behalf of Advanced Accelerator Applications, Novocure Inc, Nuvalent, Nuvation Bio Inc, Pfizer Inc, Pharmacyclics LLC, an AbbVie Company, Puma Biotechnology Inc, Regeneron Pharmaceuticals Inc, Rigel Pharmaceuticals Inc, R-Pharm US, Sanofi, Seagen Inc, Servier Pharmaceuticals LLC, SpringWorks Therapeutics Inc, Stemline Therapeutics Inc, Sumitomo Pharma America, Syndax Pharmaceuticals, Taiho Oncology Inc, Takeda Pharmaceuticals USA Inc, TerSera Therapeutics LLC, and Tesaro, A GSK Company.

RESEARCH TO PRACTICE CME PLANNING COMMITTEE MEMBERS, STAFF AND REVIEWERS — Planners, scientific staff and independent reviewers for Research To Practice have no relevant financial relationships to disclose.

These educational activities contain discussion of published and/or investigational uses of agents that are not indicated by the Food and Drug Administration. Research To Practice does not recommend the use of any agent outside of the labeled indications. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications and warnings. The opinions expressed are those of the presenters and are not to be construed as those of the publisher or grantor.

These activities are supported by an educational grant from Pfizer Inc and Astellas.

Release date: January 2026
Expiration date: January 2027

After completing the post-test, learners may download and review the answers here in order to identify further areas of study.

Aggarwal R et al. Final results from PRESTO: A phase III open-label study of combined androgen blockade in patients (pts) with high-risk biochemically relapsed prostate cancer (BRPC) (AFT-19). ESMO 2025;Abstract LBA88.

Azad AA et al. First interim efficacy analysis of the phase I/II PETRANHA trial of saruparib + androgen receptor pathway inhibitors (ARPI) in patients (pts) with metastatic prostate cancer (mPC). ESMO 2025;Abstract 2384MO.

Carles Galceran J et al. Time to response with talazoparib (TALA) + enzalutamide (ENZA) in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) in TALAPRO-2. ESMO 2025;Abstract 2428P.

Cho KS et al. Lymphovascular invasion of transurethral resection specimens as predictor as progression and metastasis in patients with newly diagnosed T1 bladder urothelial cancer. J Urol 2009;182(6):2625-30. Abstract

De Santis M et al. Durvalumab (D) in combination with bacillus Calmette-Guérin (BCG) for BCG-naïve, high-risk non-muscle-invasive bladder cancer (NMIBC): Final analysis of the phase III, open-label, randomised POTOMAC trial. ESMO 2025;Abstract LBA108.

Fizazi K et al. A phase III study of capivasertib (capi) + abiraterone (abi) vs placebo (pbo) + abi in patients (pts) with PTEN deficient de novo metastatic hormone-sensitive prostate cancer (mHSPC): CAPItello-281. ESMO 2025;Abstract 2383O.

Fizazi K et al. Capivasertib plus abiraterone in PTEN-deficient metastatic hormone-sensitive prostate cancer: CAPItello-281 phase III study. Ann Oncol 2025;[Online ahead of print]. Abstract

Galsky MD et al. Adjuvant nivolumab vs placebo for high-risk muscle-invasive urothelial carcinoma: 5-year efficacy and ctDNA results from CheckMate 274. ESMO 2025;Abstract 3068O.

Makker V et al. Trastuzumab deruxtecan (T-DXd) for pretreated patients (pts) with HER2-expressing solid tumors: DESTINY-PanTumor02 (DP-02) part 1 final analysis. ESMO 2025;Abstract 957P.

Necchi A et al. Neoadjuvant gemcitabine intravesical system (TAR-200) + cetrelimab (CET) or CET alone in patients (pts) with muscle-invasive bladder cancer (MIBC): SunRISe-4 (SR-4) primary analysis and biomarker results. ESMO 2025;Abstract LBA112.

Nguyen PL et al. Randomised phase III trial of androgen deprivation therapy (ADT) with radiation therapy with or without enzalutamide for high risk, clinically localised prostate cancer: ENZARAD (ANZUP 1303). ESMO 2025;Abstract LBA86.

Powles TB et al. IMvigor011: A phase III trial of circulating tumour (ct)DNA-guided adjuvant atezolizumab vs placebo in muscle-invasive bladder cancer. ESMO 2025;Abstract LBA8.

Powles TB et al. A randomised phase III trial of neoadjuvant durvalumab plus chemotherapy followed by radical cystectomy and adjuvant durvalumab in muscle-invasive bladder cancer (NIAGARA). ESMO 2024;Abstract LBA5.

Powles T et al. Perioperative durvalumab with neoadjuvant chemotherapy in operable bladder cancer. N Engl J Med 2024;391(19):1773-86. Abstract

Rha SY et al. Datopotamab deruxtecan (Dato-DXd) + rilvegostomig (rilve) in patients (pts) with locally advanced or metastatic urothelial cancer (a/mUC): Results from the phase II TROPION-PanTumor03 study. ESMO 2025;Abstract 3072MO.

Sheng X et al. Disitamab vedotin (DV) plus toripalimab (T) versus chemotherapy (C) in first-line (1L) locally advanced or metastatic urothelial carcinoma (la/mUC) with HER2-expression. ESMO 2025;Abstract LBA7.

Shore ND et al. EMBARK: Overall survival with enzalutamide in biochemically recurrent prostate cancer. ESMO 2025;Abstract LBA87.

Tagawa ST et al. Phase III trial of [177Lu]Lu-PSMA-617 combined with ADT + ARPI in patients with PSMA-positive metastatic hormone-sensitive prostate cancer (PSMAddition). ESMO 2025;Abstract LBA6.

van der Heijden MS et al. Health-related quality of life (HRQoL) outcomes from the NIAGARA trial of perioperative durvalumab (D) plus neoadjuvant chemotherapy (NAC) in muscle-invasive bladder cancer (MIBC). ESMO 2025;Abstract 3069MO.

Vulsteke C et al. Perioperative (periop) enfortumab vedotin (EV) plus pembrolizumab (pembro) in participants (pts) with muscle-invasive bladder cancer (MIBC) who are cisplatin-ineligible: The phase III KEYNOTE-905 study. ESMO 2025;Abstract LBA2.

Faculty

TARGET AUDIENCE
This program is intended for medical and radiation oncologists, urologists and other healthcare providers involved in the treatment of urothelial bladder cancer.

LEARNING OBJECTIVES

• Evaluate the efficacy of anti-PD-1/PD-L1 antibody therapy for muscle-invasive bladder cancer, and counsel patients about the current role of this treatment strategy.
• Consider the potential clinical role of circulating tumor DNA assessment to guide treatment decision-making and monitor for recurrence in nonmetastatic UBC.
• Review available clinical trial evidence with novel intravesical therapies under evaluation for nonmetastatic UBC, and determine the potential utility of these approaches for appropriately selected patients.
• Appreciate the biological rationale for combining anti-PD-1/PD-L1 antibodies with chemotherapy or other systemic agents with established efficacy in UBC, such as antibody-drug conjugates (ADCs), and discuss the current role of these regimens with patients about to begin first-line therapy.
• Recall pivotal clinical trial findings with novel compounds with unique mechanisms of action for previously treated locally advanced or metastatic UBC, such as ADCs and tyrosine kinase inhibitors, and identify patients for whom these approaches would be appropriate.

ACCREDITATION STATEMENT
Research To Practice is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

CREDIT DESIGNATION STATEMENT
CME credit is no longer available for this issue.

AMERICAN BOARD OF INTERNAL MEDICINE (ABIM) — MAINTENANCE OF CERTIFICATION (MOC)
CME credit is no longer available for this issue.

AMERICAN BOARD OF SURGERY (ABS) — CONTINOUS CERTIFICATION (CC)
Successful completion of these CME activities, which includes participation in the evaluation component and a post-test, enables the learner to earn credit toward the CME and Self-Assessment requirement(s) of the American Board of Surgery’s Continuous Certification program. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABS credit.

Please note, these programs have been specifically designed for the following ABS practice area: complex general surgical oncology.

PRIVACY POLICY
Personal information and data sharing: Research To Practice aggregates deidentified user data for program-use analysis, program development, activity planning and site improvement. We may provide aggregate and deidentified data to third parties, including commercial supporters. We do not share or sell personally identifiable information to any unaffiliated third parties or commercial supporters. Please see our privacy policy at ResearchToPractice.com/Privacy-Policy for more information.

HOW TO USE THIS CME ACTIVITY
Video Program: This CME activity consists of a video component. To receive credit, the participant should review the CME information, watch the video, complete the post-test with a score of 80% or better and fill out the evaluation located at ResearchToPractice.com/ASCO2025/Bladder/Video/CME.

CONTENT VALIDATION AND DISCLOSURES
Research To Practice (RTP) is committed to providing its participants with high-quality, unbiased and state-of-the-art education and adheres to the ACCME’s Standards for Integrity and Independence in Accredited Continuing Education. Any individuals in a position to control the content of an accredited continuing education activity, including faculty, planners, reviewers and others, are required to disclose all relevant financial relationships with ineligible entities (commercial interests). All relevant financial relationships have been mitigated prior to the commencement of this activity. In addition, all activity content is reviewed by RTP scientific staff and an external, independent physician reviewer for fair balance, scientific objectivity of studies referenced and patient care recommendations.

FACULTY — The following faculty reported relevant financial relationships with ineligible entities:

Andrea Necchi, MD
Associate Professor
Vita-Salute San Raffaele University
Head of Genitourinary Medical Oncology
IRCCS San Raffaele Hospital
Milan, Italy

Advisory Committees: Bristol Myers Squibb, CatalYm, Daiichi Sankyo Inc, Genenta Science, Johnson & Johnson, Merck; Consulting Agreements: AstraZeneca Pharmaceuticals LP, Gilead Sciences Inc, Johnson & Johnson, Merck, Pfizer Inc, Samsung Bioepis; Contracted Research: AstraZeneca Pharmaceuticals LP, Bristol Myers Squibb, Merck.

Thomas Powles, MBBS, MRCP, MD
Director of Barts Cancer Institute
Queen Mary University of London
London, United Kingdom

Advisory Committees and Consulting Agreements: Astellas, AstraZeneca Pharmaceuticals LP, Bristol Myers Squibb, Eisai Inc, Exelixis Inc, Incyte Corporation, Ipsen Biopharmaceuticals Inc, Johnson & Johnson, Merck Serono, MSD, Novartis, Pfizer Inc, Roche Laboratories Inc, Seagen Inc; Nonrelevant Financial Relationships: Mashup Media LLC.

SURVEY PARTICIPANTS
Terence Friedlander, MD — Advisory Committees: Aadi Bioscience, AbbVie Inc, Adaptimmune, Aktis Oncology, Astellas, Bicycle Therapeutics, Bristol Myers Squibb, Gilead Sciences Inc, Merck, Pfizer Inc, Samsung Bioepis; Consulting Agreements: Astellas, EMD Serono Inc, Pfizer Inc; Contracted Research: Bicycle Therapeutics, Genentech, a member of the Roche Group, Johnson & Johnson Pharmaceuticals, Pfizer Inc; Data and Safety Monitoring Boards/Committees: Bicycle Therapeutics. Petros Grivas, MD, PhD, FASCO — Consulting Agreements: AbbVie Inc, Astellas, AstraZeneca Pharmaceuticals LP, Bicycle Therapeutics, Bristol Myers Squibb, Daiichi Sankyo Inc, EMD Serono Inc, Foundation Medicine, Fresenius Kabi AG, Gilead Sciences Inc, Janssen Biotech Inc, Lilly, Merck, Pfizer Inc, Replimune, Roche Laboratories Inc, Strata Oncology, UroGen Pharma; Contracted Research (Paid to Institution): Acrivon Therapeutics, ALX Oncology, Bristol Myers Squibb, EMD Serono Inc, Genentech, a member of the Roche Group, Gilead Sciences Inc, Merck; Data and Safety Monitoring Boards/Committees: Bristol Myers Squibb, Strata Oncology. Jonathan E Rosenberg, MD — Advisory Committees: Astellas, Seagen Inc, Tyra Biosciences Inc; Consulting Agreements: Aadi Bioscience, Aktis Oncology, Alligator Bioscience, Astellas, AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, Boehringer Ingelheim Pharmaceuticals Inc, Bristol Myers Squibb, EMD Serono Inc, Genentech, a member of the Roche Group, Generate Biomedicines, Gilead Sciences Inc, Hengrui Therapeutics Inc, Imvax Inc, Janssen Biotech Inc, Loxo Oncology Inc, a wholly owned subsidiary of Eli Lilly & Company, Merck, Pfizer Inc, Samsung Bioepis, Seagen Inc, Tyra Biosciences Inc; Contracted Research: Astellas, AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, Seagen Inc.

MODERATOR
Matthew D Galsky, MD
Lillian and Howard Stratton Professor of Medicine
Icahn School of Medicine at Mount Sinai
Co-Leader, Bladder Cancer Center of Excellence
Associate Director, Translational Research
The Tisch Cancer Institute
New York, New York

Consulting Agreements: AbbVie Inc, AstraZeneca Pharmaceuticals LP, EMD Serono Inc, Gilead Sciences Inc, Janssen Biotech Inc, Merck, Pfizer Inc, Seagen Inc.

RESEARCH TO PRACTICE CME PLANNING COMMITTEE MEMBERS, STAFF AND REVIEWERS — Planners, scientific staff and independent reviewers for Research To Practice have no relevant financial relationships to disclose.

These educational activities contain discussion of published and/or investigational uses of agents that are not indicated by the Food and Drug Administration. Research To Practice does not recommend the use of any agent outside of the labeled indications. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications and warnings. The opinions expressed are those of the presenters and are not to be construed as those of the publisher or grantors.

These activities are supported by educational grants from Johnson & Johnson and Natera Inc.

Release date: June 2025
Expiration date: June 2026

Prof Powles

Galsky MD et al. Additional efficacy and safety outcomes and an exploratory analysis of the impact of pathological complete response (pCR) on long-term outcomes from NIAGARA. Genitourinary Cancers Symposium 2025;Abstract 659.

Milowsky M et al. Adjuvant nivolumab (NIVO) vs placebo (PBO) for high-risk muscle-invasive urothelial carcinoma (MIUC): Additional efficacy outcomes including overall survival (OS) in patients (pts) with muscle-invasive bladder cancer (MIBC) from CheckMate 274. Gastrointestinal Cancers Symposium 2025;Abstract 658.

Powles T et al. Circulating tumor DNA (ctDNA) in patients with muscle-invasive bladder cancer (MIBC) who received perioperative durvalumab (D) in NIAGARA. ASCO 2025;Abstract 4503.

Powles T et al. Perioperative durvalumab with neoadjuvant chemotherapy in operable bladder cancer. N Engl J Med 2024;391(19):1773-86. Abstract

Powles TB et al. A randomized phase III trial of neoadjuvant durvalumab plus chemotherapy followed by radical cystectomy and adjuvant durvalumab in muscle-invasive bladder cancer (NIAGARA). ESMO 2024;Abstract LBA5.

Powles TB et al. IMvigor011: A global, double-blind, randomised phase III study of atezolizumab (atezo; anti–PD-L1) vs placebo (pbo) as adjuvant therapy in patients (pts) with high-risk muscle-invasive bladder cancer (MIBC) who are circulating tumour (ct)DNA+ post cystectomy. ESMO 2021;Abstract 716TiP.

Powles TB et al. Clinical outcomes in post-operative ctDNA-positive muscle-invasive urothelial carcinoma (MIUC) patients after atezolizumab adjuvant therapy. ESMO 2020;Abstract 1O.

Sheng X et al. Neoadjuvant treatment with disitamab vedotin plus perioperative toripalimab in patients with muscle-invasive bladder cancer (MIBC) with HER2 expression: Updated efficacy and safety results from the phase II RC48-C017 trial. Genitourinary Cancers Symposium 2025;Abstract 665.

 

Prof Necchi

Bilen MA et al. Real-world (RW) treatment (Tx) patterns and clinical outcomes in patients (pts) with metastatic urothelial carcinoma (mUC) receiving first-line (1L) Tx: Results from IMPACT UC. ESMO 2021;Abstract 701P.

Catto JWF et al. Erdafitinib in BCG-treated high-risk non-muscle-invasive bladder cancer. Ann Oncol 2024;35(1):98-106. Abstract

Choi H et al. Health-related quality of life after radical cystectomy. Transl Androl Urol 2020;9(6):2997-3006. Abstract

Jeong S-H et al. Clinical determinants of recurrence in pTa bladder cancer following transurethral resection of bladder tumor. BMC Cancer 2022;22(1):631. Abstract

Kamat AM et al. Definitions, end points, and clinical trial designs for non-muscle-invasive bladder cancer: Recommendations from the International Bladder Cancer Group. J Clin Oncol 2016;34(16):1935-44. Abstract

Knowles MA, Hurst CD. Molecular biology of bladder cancer: New insights into pathogenesis and clinical diversity. Nat Rev Cancer 2015;15(1):25-41. Abstract

Li R et al. Oncolytic immunotherapy with nivolumab in muscle-invasive bladder cancer: A phase 1b trial. Nat Med 2025;31(1):176-88. Abstract

Morgans AK et al. Treatment patterns among patients with advanced urothelial carcinoma (aUC) in the USA. ESMO 2021;Abstract 704P.

Necchi A et al. TAR-200 plus cetrelimab (CET) or CET alone as neoadjuvant therapy in patients (pts) with muscle-invasive bladder cancer (MIBC) who are ineligible for or refuse neoadjuvant cisplatin-based chemotherapy (NAC): Interim analysis of SunRISe-4 (SR-4). ESMO 2024;Abstract LBA84.

Rouprêt M et al. European Association of Urology guidelines on upper urinary tract urothelial carcinoma: 2020 update. Eur Urol 2021;79(1):62-79. Abstract

Shore ND et al. Non-muscle-invasive bladder cancer: An overview of potential new treatment options. Urol Oncol 2021;39(10):642-63. Abstract

Tyson M et al. Assessment of treatment patterns of nonmuscle invasive bladder cancer patients in privately insured patients. ASCO 2019;Abstract e16012.

Vilaseca A et al. First safety and efficacy results of the TAR-210 erdafitinib (erda) intravesical delivery system in patients (pts) with non–muscle-invasive bladder cancer (NMIBC) with select FGFR alterations (alt). ESMO 2023;Abstract LBA104.

Westergren D-O et al. A nationwide, population based analysis of patients with organ confined, muscle invasive bladder cancer not receiving curative intent therapy in Sweden from 1997 to 2014. J Urol 2019;202(5):905-12. Abstract

 

Dr Galsky

Galsky MD et al. Preliminary efficacy and safety of disitamab vedotin (DV) with pembrolizumab (P) in treatment (Tx)-naive HER2-expressing, locally advanced or metastatic urothelial carcinoma (la/mUC): RC48G001 cohort C. ESMO 2024;Abstract 1967MO.

Loriot Y et al. Erdafitinib or chemotherapy in advanced or metastatic urothelial carcinoma. N Engl J Med 2023;389(21):1961-71. Abstract

Loriot Y et al. Erdafitinib in locally advanced or metastatic urothelial carcinoma. N Engl J Med 2019;381(4):338-48. Abstract

Meric-Bernstam F et al. Efficacy and safety of trastuzumab deruxtecan in patients with HER2-expressing solid tumors: Primary results from the DESTINY-PanTumor02 phase II trial. J Clin Oncol 2024;42(1):47-58. Abstract

Powles T et al. EV-302: Updated analysis from the phase 3 global study of enfortumab vedotin in combination with pembrolizumab (EV+P) vs chemotherapy (chemo) in previously untreated locally advanced or metastatic urothelial carcinoma (la/mUC). Genitourinary Cancers Symposium 2025;Abstract 664.

Powles T et al. Enfortumab vedotin and pembrolizumab in untreated advanced urothelial cancer. N Engl J Med 2024;390(10):875-88. Abstract

Siefker-Radtke AO et al. Erdafitinib versus pembrolizumab in pretreated patients with advanced or metastatic urothelial cancer with select FGFR alterations: Cohort 2 of the randomized phase III THOR trial. Ann Oncol 2024;35(1):107-17. Abstract

Siefker-Radtke AO et al. Efficacy and safety of erdafitinib in patients with locally advanced or metastatic urothelial carcinoma: Long-term follow-up of a phase 2 study. Lancet Oncol 2022;23(2):248-58. Abstract

van der Heijden MS et al. Nivolumab plus gemcitabine-cisplatin in advanced urothelial carcinoma. N Engl J Med 2023;389(19):1778-89. Abstract

Zhou L et al. Disitamab vedotin plus toripalimab in patients with locally advanced or metastatic urothelial carcinoma (RC48-C014): A phase Ib/II dose-escalation and dose-expansion study. Ann Oncol 2025;36(3):331-9. Abstract