Monday, August 3, 2020, 5:00 PM – 6:00 PM ET

Recent Advances in Medical Oncology: Urothelial Bladder Carcinoma

Join us on Monday, August 3 for the live webinar
5:00 PM – 6:00 PM ET
1 AMA PRA Category 1 CreditTM

Complimentary Registration
A link to the event will be provided after registration via an email confirmation.

A full library of presentation slides will also be made available for those who participate in this live webinar.


Faculty

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

Thomas Powles, MBBS, MRCP, MD
Professor of Genitourinary Oncology
Barts Cancer Institute
Director of Barts Cancer Centre
Queen Mary University of London
London, United Kingdom


Arlene Siefker-Radtke, MD
Professor
Department of Genitourinary Medical Oncology
Division of Cancer Medicine
The University of Texas
MD Anderson Cancer Center
Houston, Texas

Moderator
Neil Love, MD
Research To Practice
Miami, Florida


Not an official event of ASCO20 Virtual. Not sponsored, endorsed, or accredited by any of the cosponsoring organizations of ASCO20 Virtual.

Supporters
This activity is supported by educational grants from AstraZeneca Pharmaceuticals LP, Janssen Biotech Inc, administered by Janssen Scientific Affairs LLC, and Seattle Genetics.

Current Role and Ongoing Investigation of Immune Checkpoint Inhibitors in Urothelial Bladder Cancer (UBC) — Dr Balar
  • Design, entry criteria and key efficacy and safety findings from the Phase II KEYNOTE-057 trial leading to the FDA approval of pembrolizumab for patients with BCG-unresponsive, high-risk non-muscle-invasive UBC who are ineligible for or elected not to undergo cystectomy
  • Other ongoing trials of anti-PD-1/PD-L1 antibodies alone or in combination with other agents as neoadjuvant or adjuvant treatment for localized UBC (eg, KEYNOTE-676, ALBAN, POTOMAC, NIAGARA)
  • Rationale for and clinical implications of the recent revision of FDA approvals of atezolizumab and pembrolizumab limiting their use for patients with locally advanced or metastatic UBC who have not received prior therapy, are not eligible for cisplatin-containing treatment and have low expression of PD-L1
  • Available efficacy and safety results from the Phase III JAVELIN Bladder 100 trial evaluating first-line maintenance therapy with avelumab in combination with best supportive care (BSC) versus BSC alone for locally advanced or metastatic UBC not progressive following induction chemotherapy; recent FDA approval of first-line avelumab maintenance
  • Design, eligibility criteria and primary and secondary endpoints achieved in the Phase III IMvigor130 trial assessing atezolizumab alone and in combination with chemotherapy in patients with untreated locally advanced or metastatic UBC
  • Ongoing Phase III trials (eg, CheckMate 901, NILE) evaluating anti-PD-1/PD-L1 antibodies in combination with other systemic therapies
Approved and Investigational Antibody-Drug Conjugates in Advanced UBC — Prof Powles
  • Biologic rationale for targeting nectin-4 in patients with metastatic UBC; structural components and mechanism of antitumor response of enfortumab vedotin
  • Published efficacy and safety findings from the pivotal Phase II EV-201 trial leading to the FDA approval of enfortumab vedotin in patients with locally advanced or metastatic UBC; optimal integration into current management algorithms
  • Published efficacy findings with, ongoing evaluation of and FDA breakthrough therapy designation for enfortumab vedotin in combination with pembrolizumab for patients with locally advanced or metastatic UBC
  • Incidence and severity of adverse events with enfortumab vedotin; optimal monitoring and management strategies
  • Ongoing Phase III EV-301 study of enfortumab vedotin versus chemotherapy for previously treated locally advanced or metastatic UBC
  • Frequency of Trop-2 expression in UBC and mechanism of action of sacituzumab govitecan; available efficacy results and ongoing investigation in metastatic UBC
Optimal Application of FGFR-Directed Therapy in Advanced UBC — Dr Siefker-Radtke
  • Spectrum and frequency of FGFR alterations in patients with metastatic UBC
  • Mechanism of action of and available efficacy and safety data supporting the recent FDA approval of erdafitinib for patients with locally advanced or metastatic UBC with susceptible FGFR3 or FGFR2 genetic alterations who have experienced disease progression on or after chemotherapy
  • Appropriate integration of erdafitinib into current management paradigms
  • Incidence and severity of adverse events (eg, hyperphosphatemia, ocular toxicities, stomatitis) with erdafitinib; optimal monitoring and management strategies
  • Published research findings and ongoing evaluation of other FGFR-targeted agents (eg, pemigatinib, rogaratinib, vofatamab) in UBC

Program Overview
Although bladder cancer is a heterogeneous collection of diseases, more than 90% of patients are diagnosed with its most common form, urothelial carcinoma, while the remaining 10% present with less prevalent phenotypes, including squamous, small cell and adenocarcinomas. Given the somewhat limited presentation of these other manifestations, this activity will focus almost exclusively on the current and future management of urothelial carcinoma, including a number of novel agents and strategies that have yielded favorable outcomes and led to a spate of FDA approvals.

Target Audience
This program is intended for medical oncologists, hematology-oncology fellows and other allied healthcare professionals involved in the treatment of bladder cancer.

Learning Objectives
At the conclusion 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 Bacillus Calmette-Guérin, 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 available clinical trial data leading to the recent FDA approval of the anti-PD-L1 antibody avelumab as maintenance therapy following 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.
  • 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.
  • 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.

Competencies to Be Addressed
Patient Care and Procedural Skills and Medical Knowledge

CME Credit Form
CME and ABIM MOC credit form links will be emailed to each participant within 5 days of the conclusion of the activity.

Contact Information
If you have questions regarding credit, please contact cpdsupport@usf.edu, or call 813-224-7860.

Accreditation Statement
USF Health is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

USF Health designates this live activity 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 short 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.

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. For those clinicians wishing to receive ABIM MOC credit for attending, you will receive an email after the event with instructions.

Privacy Disclosure
Learners provide permission for USF Health to share their completion data with ACCME, who will transmit same on their behalf to ABIM. Within 60 days of the end of the activity, USF Health will upload to ACCME the participant data of physicians who have met the ABIM MOC Points requirements; ACCME will transmit the same to ABIM.

Completion Requirements
Physicians seeking ABIM Points will be required to take an evaluation/post-test passing with a score of 80% or higher.

Disclaimer
The information provided at this CME activity is for continuing education purposes only and is not meant to substitute for the independent medical/clinical judgment of a healthcare provider relative to diagnostic and treatment options of a specific patient’s medical condition.

Equal Opportunity Statement
USF Health is an Equal Opportunity/Affirmative Action/Equal Access Institution.

Content Validation and Disclosures
USF Health adheres to ACCME Standards regarding commercial support of continuing medical education. It is the policy of USF Health and Research To Practice that the faculty and planning committee disclose real or apparent conflicts of interest relating to the topics of this educational activity, that relevant conflict(s) of interest are resolved and also that speakers will disclose any unlabeled/unapproved use of drug(s) or device(s) during their presentation.

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, 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. Prof PowlesConsulting Agreements: Astellas, AstraZeneca Pharmaceuticals LP, Bristol-Myers Squibb Company, Eisai Inc, Exelixis Inc, Incyte Corporation, Ipsen Biopharmaceuticals Inc, Johnson & Johnson Pharmaceuticals, Merck Serono, Merck Sharp & Dohme Corp, Novartis, Pfizer Inc, Roche Laboratories Inc, Seattle Genetics; Contracted Research: Astellas, AstraZeneca Pharmaceuticals LP, Bristol-Myers Squibb Company, Eisai Inc, Exelixis Inc, Ipsen Biopharmaceuticals Inc, Johnson & Johnson Pharmaceuticals, Merck Serono, Merck Sharp & Dohme Corp, Novartis, Pfizer Inc, Roche Laboratories Inc, Seattle Genetics. Dr Siefker-RadtkeAdvisory Committee: AstraZeneca Pharmaceuticals LP, Bavarian Nordic, Genentech, a member of the Roche Group, Janssen Biotech Inc, Merck, Mirati Therapeutics, Nektar, Pfizer Inc, Seattle Genetics; Contracted Research: Janssen Biotech Inc; Speakers Bureau: Janssen Biotech 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, 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.

USF HEALTH CPD STAFF AND RESEARCH TO PRACTICE CME PLANNING COMMITTEE — No relevant conflicts to disclose.

Supporters
This activity is supported by educational grants from AstraZeneca Pharmaceuticals LP, Janssen Biotech Inc, administered by Janssen Scientific Affairs LLC, and Seattle Genetics.