Second Opinion: Integrating Novel Approaches into the Management of Non-Muscle-Invasive and Muscle-Invasive Bladder Cancer — Microlearning Activities — Microlearning Activity 1

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