Clinical Investigator Perspectives on the Most Relevant New Datasets and Advances in Non-Muscle-Invasive and Muscle-Invasive Urothelial Bladder Cancer — Faculty Presentation — Ashish M Kamat, MD, MBBS

Faculty

TARGET AUDIENCE
This activity is intended for medical oncologists, radiation oncologists, urologists, surgeons, hematology-oncology fellows and other healthcare professionals 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 nonmetastatic bladder cancer, and optimally incorporate these approaches into the care of appropriately selected patients with NMIBC.
• Analyze the biological basis for the use of perioperative immune checkpoint inhibitor therapy for muscle-invasive bladder cancer (MIBC), and evaluate available data documenting the efficacy and safety of this therapeutic strategy.
• Appraise recently presented clinical research findings with perioperative anti-PD-1 antibody therapy in combination with antibody-drug conjugate therapy for patients with MIBC, and consider the current and potential role of this novel approach.
• Develop an understanding of the clinical relevance of circulating tumor DNA (ctDNA) as a prognostic and predictive biomarker in MIBC, and evaluate available research documenting the benefit of adjuvant anti-PD-1/PD-L1 antibody therapy for patients with detectable ctDNA after cystectomy.
• Assess the biological rationale for, available research findings with and potential role of promising investigational agents and strategies for patients with 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 1 AMA PRA Category 1 Credit™. 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 Medical Knowledge MOC point 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 — The following faculty reported relevant financial relationships with ineligible entities:

Dr Kamat — Advisory Committees and Consulting Agreements: Astellas, Atonco, Biological Dynamics, Bristol Myers Squibb, Carisma Therapeutics, CG Oncology, Cystotech, Eisai Inc, enGene, Ferring Pharmaceuticals, Genentech, a member of the Roche Group, Imagin Medical, ImmunityBio, Imvax Inc, Incyte Corporation, Janssen Biotech Inc, Medac, Merck, Nonagen Bioscience, Pfizer Inc, Photocure, Protara Therapeutics, Roche Laboratories Inc, Seagen Inc, Theralase, Urogen Pharma, US Biotest Inc, Valar Labs, Vivet Therapeutics; Patents: CyPRIT (Cytokine Predictors of Response to Intravesical Therapy) — Joint patent with MD Anderson Cancer Center # 00043705; Research Funding: Arquer Diagnostics, enGene, Ferring Pharmaceuticals Photocure, Seagen Inc; Nonrelevant Financial Relationships: American Urological Association (AUA), European Urology Oncology, International Bladder Cancer Group (IBCG), Journal of Urology, Patient-Centered Outcomes Research Institute (PCORI), SWOG, UroToday, World Bladder Cancer Patient Coalition. Prof Powles — Advisory Committees: 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; Consulting Agreements: Astellas, AstraZeneca Pharmaceuticals LP, Bristol Myers Squibb, Eisai Inc, Exelixis Inc, Ipsen Biopharmaceuticals Inc, Johnson & Johnson, Merck Serono, MSD, Novartis, Pfizer Inc, Roche Laboratories Inc, Seagen Inc; Nonrelevant Financial Relationships: Mashup Media LLC.

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 Genentech, a member of the Roche Group, and Natera Inc.

Release date: June 2026
Expiration date: June 2027

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

Chang SS et al. Prolonged progression-free survival, disease-free survival, and cystectomy avoidance with IL-15 receptor lymphocyte-stimulating agent NAI plus bacillus Calmette-Guerin in bacillus Calmette-Guerin-unresponsive papillary-only nonmuscle-invasive bladder cancer. J Urol 2026;215(1):44-56. Abstract

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

Daneshmand S et al. TAR-200 for bacillus Calmette-Guerin-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 in combination with BCG for BCG-naive, high-risk, non-muscle-invasive bladder cancer (POTOMAC): Final analysis of a randomised, open-label, phase 3 trial. Lancet 2025;406(10516):2221-34. 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

Galsky MD et al. Neoadjuvant and adjuvant enfortumab vedotin (EV) plus pembrolizumab (pembro) for participants with muscle-invasive bladder cancer (MIBC) who are eligible for cisplatin: Randomized, open-label, phase 3 KEYNOTE-B15 study. Genitourinary Cancers Symposium 2026;Abstract LBA630. Abstract

Ghatalia P et al. Circulating tumor DNA (ctDNA) to guide response-adapted bladder preservation in muscle invasive bladder cancer (MIBC): Integrated analysis of the RETAIN trials. Genitourinary Cancers Symposium 2026;Abstract LBA632.

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.

Hayne D et al. Mitomycin plus BCG as adjuvant intravesical therapy for high-risk, non–muscle-invasive bladder cancer: A randomized phase 3 trial (ANZUP 1301). ASCO 2025;Abstract LBA4504.

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.

Meeks JJ et al. The first report of disease-free survival analyses from the NIAGARA trial of perioperative durvalumab plus neoadjuvant chemotherapy in muscle-invasive bladder cancer. AUA 2025;Abstract PD37-09.

Mellema J-JJ et al. Ipilimumab and nivolumab followed by chemoradiotherapy as bladder-sparing treatment in muscle-invasive bladder cancer: A phase 2 trial. Nat Med 2026;32(4):1241-8. Abstract

Powles T et al. Circulating tumor (ct)DNA-guided adjuvant atezolizumab (atezo) in muscle-invasive bladder cancer (MIBC): Exploratory analysis of ctDNA dynamics in the IMvigor011 trial. Genitourinary Cancers Symposium 2026;Abstract 633.

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

Roupret M et al. ALBAN (GETUG-AFU 37): A phase III, randomized, open-label international trial of intravenous atezolizumab and intravesical bacillus Calmette-Guérin (BCG) versus BCG alone in BCG-naive high-risk, non-muscle-invasive bladder cancer (NMIBC). Ann Oncol 2026;37(1):44-52. Abstract

Shore ND et al. Sasanlimab plus BCG in BCG-naive, high-risk non-muscle invasive bladder cancer: The randomized phase 3 CREST trial. Nat Med 2025;31(8):2806-14. Abstract

Van Der Heijden MS et al. Urinary tumor DNA (utDNA) and circulating tumor DNA (ctDNA) in patients (pts) with muscle-invasive bladder cancer (MIBC) who received perioperative durvalumab (D) in NIAGARA. Genitourinary Cancers Symposium 2026;Abstract 636.

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

Wang B et al. Real-world experience with a commercial circulating tumor DNA assay in non-muscle-invasive bladder cancer. Eur Urol Oncol 2025;8(4):883-7. Abstract