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

LEARNING OBJECTIVES

• Identify available clinical trial data supporting the FDA approvals of various immune checkpoint inhibitors for the treatment of urothelial bladder carcinoma (UBC) to determine the current utility of these agents in clinical practice.
• Consider the recent FDA approval of pembrolizumab for high-risk, non-muscle-invasive UBC that is unresponsive to BCG, and determine how this agent can be appropriately integrated into current care.
• Evaluate available and emerging data investigating the use of anti-PD-1/PD-L1 antibodies as neoadjuvant or adjuvant therapy for muscle-invasive bladder cancer, and refer eligible patients for appropriate trial participation.
• Understand the clinical implications of the recent revision to the FDA approvals of atezolizumab and pembrolizumab in first-line therapy endorsing their use for patients with metastatic UBC who are ineligible for cisplatin and whose tumors express PD-L1 or for those who are ineligible for any platinum-based chemotherapy regardless of PD-L1 expression.
• Evaluate available clinical trial data with anti-PD-1/PD-L1 antibodies as maintenance therapy after first-line chemotherapy for patients with previously untreated metastatic UBC, and consider the potential role of this approach in routine practice.
• Appraise available research data and ongoing clinical trials evaluating anti-PD-1/PD-L1 antibodies in combination with chemotherapy or targeted agents for UBC, and counsel appropriately selected patients about participation in active research protocols.
• Recognize the FDA approval of erdafitinib for patients with advanced UBC and susceptible FGFR3 or FGFR2 genetic alterations whose disease has progressed during or after at least 1 line of platinum-containing chemotherapy, and determine how this agent may be appropriately integrated into clinical practice.
• Recall the mechanism of action and pivotal clinical trial findings with enfortumab vedotin for previously treated locally advanced or metastatic UBC, and identify patients for whom treatment with this novel compound would be appropriate.
• Educate patients about the side effects and toxicities associated with approved therapies commonly employed in the management of UBC, and provide preventive strategies to reduce or ameliorate these toxicities.

ACCREDITATION STATEMENT
Research To Practice is accredited by the Accreditation Council for Continuing Medical Education 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

HOW TO USE THESE CME ACTIVITIES
Audio Program: This CME activity consists of an audio component.
CME credit is no longer available for this issue

Video Program: This CME activity consists of a video component.
CME credit is no longer available for this issue

CONTENT VALIDATION AND DISCLOSURES
Research To Practice (RTP) is committed to providing its participants with high-quality, unbiased and state-of-the-art education. We assess conflicts of interest with faculty, planners and managers of CME activities. Conflicts of interest are identified and resolved through a conflict of interest resolution process. In addition, all activity content is reviewed by both a member of the 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 (and their spouses/partners) reported relevant conflicts of interest, which have been resolved through a conflict of interest resolution process:

Arjun Balar, MD
Associate Professor, Department of Medicine
Director, Genitourinary Medical Oncology Program
NYU Perlmutter Cancer Center
New York, New York

Consulting Agreements: AstraZeneca Pharmaceuticals LP, Genentech, a member of the Roche Group, Janssen Biotech Inc, Merck, Nektar, Pfizer Inc, Seattle Genetics; Contracted Research: AstraZeneca Pharmaceuticals LP, Genentech, a member of the Roche Group, Immunomedics Inc, Janssen Biotech Inc, Merck, Nektar, Pfizer Inc, Seattle Genetics.

Siamak Daneshmand, MD
Associate Professor of Urology (Clinical Scholar)
Director of Urologic Oncology
Director of Clinical Research
Urologic Oncology Fellowship Director
USC/Norris Comprehensive Cancer Center
Institute of Urology
Los Angeles, California

Advisory Committee: Ferring Pharmaceuticals, Janssen Biotech Inc, Photocure Inc; Consulting Agreements: AbbVie Inc, Aduro Biotech, Bristol-Myers Squibb Company, Ferring Pharmaceuticals, Janssen Biotech Inc, Johnson & Johnson Pharmaceuticals, Nucleix, Olympus, Pacific Edge Ltd, Photocure Inc, QED Therapeutics, Seattle Genetics; Contracted Research: Bristol-Myers Squibb Company, Janssen Biotech Inc, MDxHealth, Photocure Inc, QED Therapeutics, Taris Biomedical LLC; Data and Safety Monitoring Board/Committee: Spectrum Pharmaceuticals Inc; Ownership Interest: Taris Biomedical LLC.

Ashish M Kamat, MD, MBBS
Professor of Urologic Oncology (Surgery)
Wayne B Duddlesten Professor of Cancer Research
Department of Urology, Division of Surgery
The University of Texas MD Anderson Cancer Center
Houston, Texas

Advisory Committee and Consulting Agreements: Abbott Laboratories, Arquer Diagnostics, Asieris Pharmaceuticals, AstraZeneca Pharmaceuticals LP, Bristol-Myers Squibb Company, Cepheid, CG Oncology Inc, Eisai Inc, enGene Inc, Ferring Pharmaceuticals, Imagine Pharma, Janssen Biotech Inc, MDxHealth, Medexus Pharma Inc, Merck, Pfizer Inc, Photocure Inc, Protara Therapeutics Inc, Rainier Therapeutics, Roivant Sciences Ltd, Seattle Genetics, Sesen Bio, Theralase Technologies Inc, TMC Innovation, US Biotest Inc; Contracted Research: Bristol-Myers Squibb Company, Cubist Pharmaceuticals Inc, FKD Therapies Oy, Heat Biologics Inc, Merck, National Institutes of Health, Photocure Inc, SPORE (NIH Grant), SWOG Cancer Research Network, The Leo & Anne Albert Institute for Bladder Cancer Care and Research; Patent: CyPRIT-Cytokine Panel for Response to Intravesical Immunotherapy joint with UT/MDACC.

Jonathan E Rosenberg, MD
Chief, Genitourinary Medical Oncology Service
Division of Solid Tumor Oncology
Enno W Ercklentz Chair
Memorial Sloan Kettering Cancer Center
New York, New York

Consulting Agreements: Astellas, AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, Boehringer Ingelheim Pharmaceuticals Inc, Bristol-Myers Squibb Company, Genentech, a member of the Roche Group, GlaxoSmithKline, Janssen Biotech Inc, Merck, Mirati Therapeutics, Seattle Genetics; Contracted Research: Astellas, AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, Genentech, a member of the Roche Group, QED Therapeutics, Seattle Genetics; Data and Safety Monitoring Board/Committee: Rainier Therapeutics.

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 commercial interests: 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 commercial interests: AbbVie Inc, Acerta Pharma — A member of the AstraZeneca Group, Adaptive Biotechnologies Corporation, Agendia Inc, Agios Pharmaceuticals Inc, Amgen Inc, Array BioPharma Inc, a subsidiary of Pfizer Inc, Astellas, AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, Biodesix Inc, bioTheranostics Inc, Blueprint Medicines, Boehringer Ingelheim Pharmaceuticals Inc, Boston Biomedical Inc, Bristol-Myers Squibb Company, Celgene Corporation, Clovis Oncology, Daiichi Sankyo Inc, Dendreon Pharmaceuticals Inc, Eisai Inc, EMD Serono Inc, Exelixis Inc, Foundation Medicine, Genentech, a member of the Roche Group, Genmab, Genomic Health Inc, Gilead Sciences Inc, GlaxoSmithKline, Grail Inc, Guardant Health, Halozyme Inc, Helsinn Healthcare SA, ImmunoGen Inc, Incyte Corporation, Infinity Pharmaceuticals Inc, Ipsen Biopharmaceuticals Inc, Janssen Biotech Inc, administered by Janssen Scientific Affairs LLC, Jazz Pharmaceuticals Inc, Kite, A Gilead Company, Lexicon Pharmaceuticals Inc, Lilly, Loxo Oncology Inc, a wholly owned subsidiary of Eli Lilly & Company, Merck, Merrimack Pharmaceuticals Inc, Myriad Genetic Laboratories Inc, Natera Inc, Novartis, Oncopeptides, Pfizer Inc, Pharmacyclics LLC, an AbbVie Company, Prometheus Laboratories Inc, Puma Biotechnology Inc, Regeneron Pharmaceuticals Inc, Sandoz Inc, a Novartis Division, Sanofi Genzyme, Seattle Genetics, Sirtex Medical Ltd, Spectrum Pharmaceuticals Inc, Taiho Oncology Inc, Takeda Oncology, Tesaro, A GSK Company, Teva Oncology, Tokai Pharmaceuticals Inc, Tolero Pharmaceuticals 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 conflicts of interest 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 Astellas and Seattle Genetics and Merck.

Release date: August 2020
Expiration date: August 2021