Consensus or Controversy? Clinical Investigators Provide Perspectives on the Current and Future Clinical Care of Patients with Urothelial Bladder Cancer — Symposium Video Proceedings

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
Video Program: Research To Practice designates this enduring material for a maximum of 1.25 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 component and a post-test, enables the participant to earn up to 1.25 (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) — 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
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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

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

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