LIVE WEBINAR: Thursday, March 4, 2021, 5:00 PM – 6:15 PM Eastern Time

Cases from the Community: Investigators Discuss Emerging Research and Actual Patients with Urothelial Bladder Carcinoma (Part 3 of a 3-Part Series)

A CME Webinar Series Held in Conjunction with the 2021 Genitourinary Cancers Symposium

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Register for either or both the Feb 25 and Mar 4 complimentary events with the “Register Now” button above,
which will take you to our Zoom registration page.

Join us on Thursday, March 4th for this CME-accredited webinar
5:00 PM – 6:15 PM Eastern Time

Faculty

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

Elisabeth I Heath, MD
Associate Center Director, Translational Sciences
Chair, Genitourinary Oncology Multidisciplinary Team
Professor of Oncology and Medicine
Hartmann Endowed Chair for Prostate Cancer Research
Director, Prostate Cancer Research
Karmanos Cancer Institute
Wayne State University School of Medicine
Detroit, Michigan



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

Moderator
Neil Love, MD
Research To Practice
Miami, Florida


This activity is supported by educational grants from Astellas and Seagen Inc and Merck.

Not an official event of the 2021 Genitourinary Cancers Symposium. Not sponsored, endorsed, or accredited by any of the cosponsoring organizations of the 2021 Genitourinary Cancers Symposium.

Thursday, March 4, 2021
5:00 PM – 6:15 PM Eastern Time
Live CME-accredited webinar

Agenda

MODULE 1: Evolving Management of Nonmetastatic Urothelial Bladder Cancer (UBC)

  • Efficacy and safety findings from the KEYNOTE-057 trial supporting the FDA approval of pembrolizumab monotherapy in individuals with high-risk non-muscle-invasive BC (NMIBC) whose disease is unresponsive or refractory to BCG therapy; selection of appropriate patients for pembrolizumab therapy
  • Biologic rationale for the evaluation of anti-PD-1/PD-L1 antibodies in combination with BCG in NMIBC; ongoing Phase III trials (eg, ALBAN, POTOMAC, KEYNOTE-676) evaluating this approach
  • Rates of pathologic complete response and other clinically relevant outcomes with neoadjuvant pembrolizumab and atezolizumab in patients with resectable MIBC in the Phase II PURE-01 and ABACUS trials, respectively
  • Ongoing research examining the feasibility of combining anti-PD-1/PD-L1 antibodies with other systemic options (eg, chemotherapy, other immunotherapy) in the neoadjuvant setting
  • Available data with and ongoing Phase III trials of anti-PD-1/PD-L1 antibodies as adjuvant therapy for patients with MIBC

MODULE 2: Current Approaches to the Treatment of Newly Diagnosed Metastatic UBC (mUBC)

  • FDA approvals and current clinical role of atezolizumab and pembrolizumab as first-line treatment for mUBC; importance of chemotherapy eligibility and PD-L1 status in patient selection for this strategy
  • Key efficacy and safety findings from the Phase III JAVELIN Bladder 100 trial comparing first-line maintenance therapy with avelumab to best supportive care in patients with mUBC that did not progress after front-line chemotherapy
  • FDA approval of avelumab maintenance and current clinical role in mUBC
  • Similarities and differences in the designs, eligibility criteria and primary and secondary endpoints of the Phase III IMvigor130 and KEYNOTE-361 trials evaluating the addition of atezolizumab and pembrolizumab, respectively, to platinum-based chemotherapy for patients with previously untreated mUBC
  • Clinical implications of the recently presented results from IMvigor130 and KEYNOTE-361; current role, if any, of chemoimmunotherapy in front-line mUBC

MODULE 3: Selection and Sequencing of Therapy for Relapsed UBC

  • Spectrum and frequency of FGFR alterations in patients with mUBC; indications for molecular assessment of FGFR abnormalities in UBC and optimal testing platforms
  • Efficacy and safety data supporting the FDA approval of erdafitinib for patients with mUBC with susceptible FGFR3 or FGFR2 genetic alterations who have experienced disease progression on or after chemotherapy; appropriate integration into current treatment paradigms
  • Design, eligibility criteria and key efficacy and safety endpoints of the ongoing Phase III THOR trial evaluating erdafitinib versus chemotherapy or pembrolizumab in patients with metastatic or unresectable UBC with an FGFR gene alteration whose disease has progressed on or after 1 or 2 prior lines of therapy
  • Biologic rationale for targeting nectin-4 in patients with mUBC; structural components and mechanism of antitumor response of enfortumab vedotin
  • Published efficacy and safety findings from the pivotal Phase II EV-201 study evaluating enfortumab vedotin in patients with mUBC
  • FDA approval, practical use and ongoing evaluation (Phase III EV-301 trial) of enfortumab vedotin in progressive mUBC
  • Incidence, severity and management of side effects reported with erdafitinib and enfortumab vedotin

MODULE 4: New Directions in the Management of Advanced UBC

  • Biologic rationale for and available data with anti-PD-1/PD-L1 antibodies combined with anti-CTLA-4 antibodies for mUBC
  • Ongoing Phase III trials (eg, CheckMate 901, NILE) evaluating dual checkpoint inhibitor therapy with or without chemotherapy; anticipated completion dates
  • Available efficacy and safety findings from the Phase II EV-103 study evaluating pembrolizumab in combination with enfortumab vedotin for patients with mUBC
  • FDA breakthrough therapy designation for first-line pembrolizumab/enfortumab vedotin for cisplatin-ineligible patients with mUBC; ongoing evaluation and potential clinical role
  • Other promising agents and strategies currently under investigation for patients with mUBC

Target Audience
This activity has been designed to meet the educational needs of medical and radiation oncologists, urologists and other allied healthcare professionals involved in the treatment of urothelial bladder carcinoma.

Learning Objectives
Upon completion of this activity, participants should be able to

  • Compare and contrast the available clinical trial evidence with the use of 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 data and ongoing trials 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 study participation.
  • Review published clinical trial data leading to the recent FDA approval of the anti-PD-L1 antibody avelumab as maintenance therapy after response to first-line platinum-based chemotherapy for patients with metastatic UBC, and incorporate this novel treatment strategy into current management algorithms.
  • Assess available and emerging clinical trial data evaluating the use of anti-PD-1/PD-L1 antibodies in combination with 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 targeted agents or other immunotherapeutic strategies for metastatic 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 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.
  • Develop an understanding of the mechanisms of action of, available research findings with and ongoing studies evaluating promising investigational agents with potential efficacy in patients with metastatic UBC.

CME Credit Form
A CME credit form will be emailed to participants within 3 business days of the activity.

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
Research To Practice designates this live activity 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.

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:

Dr BalarConsulting Agreements: AstraZeneca Pharmaceuticals LP, Genentech, a member of the Roche Group, Janssen Biotech Inc, Merck, Nektar, Pfizer Inc, Seagen Inc; Contracted Research: AstraZeneca Pharmaceuticals LP, Genentech, a member of the Roche Group, Immunomedics Inc, Janssen Biotech Inc, Merck, Nektar, Pfizer Inc, Seagen Inc. Dr HeathAdvisory Committee: AstraZeneca Pharmaceuticals LP, Bristol-Myers Squibb Company, Sanofi Genzyme; Consulting Agreement: Astellas; Contracted Research: Astellas, AstraZeneca Pharmaceuticals LP, Boehringer Ingelheim Pharmaceuticals Inc, Bristol-Myers Squibb Company, Caris Life Sciences, Celgene Corporation, Celldex Therapeutics, Corcept Therapeutics, CureMeta LLC, Dendreon Pharmaceuticals Inc, eFFECTOR Therapeutics Inc, Esanik Therapeutics, Fortis Therapeutics, Genentech, a member of the Roche Group, GlaxoSmithKline, Ignyta Inc, Inovio Pharmaceuticals Inc, Medivation Inc, a Pfizer Company, Merck, Merck Sharp & Dohme Corp, Oncolys BioPharma, Plexxikon Inc, Seagen Inc, Synta Pharmaceuticals Corp, Takeda Oncology, Tokai Pharmaceuticals Inc, Zenith Epigenetics; Paid Travel: Astellas, Caris Life Sciences, Seagen Inc; Speakers Bureau: Sanofi Genzyme. Dr RosenbergAdvisory Committee: Astellas, Seagen Inc; Consulting Agreements: Astellas, AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, Boehringer Ingelheim Pharmaceuticals Inc, Bristol-Myers Squibb Company, EMD Serono Inc, Genentech, a member of the Roche Group, GlaxoSmithKline, Janssen Biotech Inc, Merck, Mirati Therapeutics, Pfizer Inc, Seagen Inc; Contracted Research: Astellas, AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, Genentech, a member of the Roche Group, QED Therapeutics, Seagen Inc.

MODERATORDr 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, Aveo Pharmaceuticals, Bayer HealthCare Pharmaceuticals, BeiGene Ltd, Biodesix Inc, bioTheranostics Inc, Blueprint Medicines, Boehringer Ingelheim Pharmaceuticals Inc, Bristol-Myers Squibb Company, Celgene Corporation, Clovis Oncology, Daiichi Sankyo Inc, Dendreon Pharmaceuticals Inc, Eisai Inc, EMD Serono Inc, Epizyme Inc, Exact Sciences Inc, Exelixis Inc, Five Prime Therapeutics Inc, Foundation Medicine, Genentech, a member of the Roche Group, Genmab, 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, Karyopharm Therapeutics, 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, Novocure Inc, Oncopeptides, Pfizer Inc, Pharmacyclics LLC, an AbbVie Company, Prometheus Laboratories Inc, Puma Biotechnology Inc, Regeneron Pharmaceuticals Inc, Sandoz Inc, a Novartis Division, Sanofi Genzyme, Seagen Inc, Sirtex Medical Ltd, Spectrum Pharmaceuticals Inc, Sumitomo Dainippon Pharma Oncology Inc, Taiho Oncology Inc, Takeda Oncology, Tesaro, A GSK Company, Teva Oncology, Tokai Pharmaceuticals Inc 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.

Supporters
This activity is supported by educational grants from Astellas and Seagen Inc and Merck.