Friday, January 26, 2024, San Francisco, California, 7:00 PM – 9:00 PM Pacific Time (10:00 PM – 12:00 AM Eastern Time)

Consensus or Controversy? Clinical Investigators Provide Perspectives on the Current and Future Management of Urothelial Bladder Cancer

Part 2 of a 2-Part CME Symposium Series Held in Conjunction with the 2024 ASCO Genitourinary Cancers Symposium

Location
San Francisco Marriott Marquis
780 Mission Street
San Francisco, California
Hotel Phone: (415) 896-1600

Program Schedule — Pacific Time
6:45 PM – 7:00 PM — Registration
7:00 PM – 9:00 PM — Educational Dinner Meeting

Meeting Room
Golden Gate Ballroom — Salon A (B2 Level)


This event will also be webcast live.
Please see Registration tab for details.
There is no registration fee for this event. For the in-person symposium in San Francisco, preregistration is required as seating is limited.  
 
Faculty
Matthew Milowsky, MD, FASCO
George Gabriel and Frances Gable Villere Distinguished Professor
Vice Chief for Research and Education
Section Chief, Genitourinary Oncology
UNC Division of Oncology
Co-Lead, Clinical and Translational Research
Co-Director, Urologic Oncology Program
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina

Peter H O'Donnell, MD
Associate Professor of Medicine
Department of Medicine
The University of Chicago
Chicago, Illinois

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

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
Evan Y Yu, MD
Section Head, Medical Oncology, Clinical Research Division
Fred Hutchinson Cancer Center
Medical Director, Clinical Research Support
Fred Hutchinson Cancer Research Consortium
Professor of Medicine
Division of Hematology and Oncology, Department of Medicine
University of Washington School of Medicine
Seattle, Washington



This activity is supported by educational grants from AstraZeneca Pharmaceuticals LP, Bristol Myers Squibb, Daiichi Sankyo Inc, and Janssen Biotech Inc, administered by Janssen Scientific Affairs LLC.
Program Schedule — Pacific Time
6:45 PM – 7:00 PM — Registration
7:00 PM – 9:00 PM — Educational Dinner Meeting

MODULE 1: Role of Anti-PD-1/PD-L1 Antibodies in Therapy for Nonmetastatic Urothelial Bladder Cancer (UBC) — Dr Milowsky

  • Key findings from the KEYNOTE-057 trial informing the selection of patients with high-risk BCG-unresponsive non-muscle-invasive bladder cancer (NMIBC) for pembrolizumab therapy
  • Ongoing Phase III trials investigating the combination of BCG and anti-PD-1/PD-L1 antibodies for BCG-naïve and BCG-unresponsive NMIBC
  • Clinically relevant outcomes achieved in early trials evaluating neoadjuvant immune checkpoint inhibitor therapy for resectable muscle-invasive bladder cancer (MIBC)
  • Extended follow-up from the Phase III CheckMate 274 trial comparing adjuvant nivolumab to placebo after radical surgery for high-risk MIBC
  • Emerging findings from the Phase III AMBASSADOR/KEYNOTE-123 study of adjuvant pembrolizumab for patients with MIBC
  • Ongoing Phase III studies evaluating anti-PD-1/PD-L1 antibodies combined with chemotherapy, chemoradiation therapy, other immune checkpoint inhibitors or targeted therapies for patients with MIBC

MODULE 2: Other Novel Strategies Under Investigation for Nonmetastatic UBC — Dr O’Donnell

  • Mechanism of antitumor activity and early data with the novel intravesical drug delivery system TAR-200
  • Design, eligibility criteria and key efficacy and safety endpoints of the Phase II SunRISe-1 study evaluating TAR-200 and cetrelimab, TAR-200 alone or cetrelimab alone for patients with BCG-unresponsive high-risk NMIBC who are ineligible for or decline radical cystectomy
  • Initial results from SunRISe-1; complete response rates with TAR-200 monotherapy and cetrelimab monotherapy
  • Ongoing studies of TAR-200 with and without cetrelimab for NMIBC, such as SunRISe-3, and MIBC, such as SunRISe-2 and SunRISe-4
  • Preliminary safety and efficacy results with the TAR-210 erdafitinib intravesical delivery system for patients with NMIBC and select FGFR alterations
  • Early results with other novel agents for patients with nonmetastatic UBC

MODULE 3: Front-Line Treatment for Metastatic UBC (mUBC) — Dr Rosenberg

  • Long-term follow-up with maintenance avelumab after front-line chemotherapy for mUBC
  • Efficacy and safety results from key studies of enfortumab vedotin in combination with pembrolizumab for previously untreated mUBC, such as cohort K of EV-103/KEYNOTE-869 and EV-302/KEYNOTE-A39
  • Recent FDA approval of enfortumab vedotin/pembrolizumab as front-line therapy regardless of cisplatin eligibility; optimal integration into routine clinical practice
  • Recently presented findings from the Phase III CheckMate 901 substudy of nivolumab in combination with chemotherapy and continued as monotherapy compared to chemotherapy alone as first-line treatment for cisplatin-eligible patients with mUBC
  • FDA priority review status and potential clinical role of up-front nivolumab/chemotherapy
  • Preliminary data with and ongoing trials of other novel combination strategies for treatment-naïve mUBC (eg, erdafitinib and cetrelimab, anti-PD-1/PD-L1 antibodies and anti-CTLA-4 antibodies with or without chemotherapy)

MODULE 4: Emerging Role of HER2-Targeted Therapy for mUBC — Dr Yu

  • Frequency of HER2 expression among patients with mUBC; optimal timing of and approach to testing
  • Proportion of patients with mUBC in the Phase II DESTINY-PanTumor02 trial of trastuzumab deruxtecan (T-DXd) for pretreated HER2-expressing solid tumors
  • Outcomes observed with T-DXd in the UBC cohort of DESTINY-PanTumor02 and clinical implications
  • Mechanism of action and structural components of the HER2-targeted antibody-drug conjugate disitamab vedotin
  • Available efficacy and safety data with disitamab vedotin for patients with previously treated HER2-positive and HER2-low or HER2-negative mUBC
  • Preliminary efficacy and safety data with regimens combining HER2-targeted antibody-drug conjugates and immunotherapy for mUBC, such as T-DXd/nivolumab, disitamab vedotin/toripalimab and disitamab vedotin/pembrolizumab; ongoing Phase III studies

MODULE 5: Selection and Sequencing of Therapy for Relapsed/Refractory mUBC — Dr Siefker-Radtke

  • Key factors affecting the selection and sequencing of available therapies for patients with progressive mUBC
  • Long-term findings with enfortumab vedotin for patients with progressive mUBC; optimal integration into current treatment paradigms
  • Key efficacy and safety data, including recently presented findings from the Phase III THOR trial, with erdafitinib for patients with relapsed mUBC and susceptible FGFR3 or FGFR2 genetic alterations; current clinical role
  • Principal efficacy and safety findings with sacituzumab govitecan for patients with progressive mUBC; optimal use and ongoing evaluation
  • Spectrum, frequency and severity of adverse events reported with enfortumab vedotin, erdafitinib and sacituzumab govitecan for mUBC; approaches to monitoring and management

Target Audience
This activity is intended for medical and radiation oncologists, urologists and other healthcare providers involved in the treatment of urothelial bladder cancer.

Learning Objectives
At the conclusion of this activity, participants should be able to

  • Consider available data supporting anti-PD-1 antibody therapy for high-risk non-muscle-invasive bladder cancer (NMIBC) that is unresponsive to BCG, and determine how this strategy can be appropriately integrated into current care.
  • Evaluate the efficacy of adjuvant anti-PD-1 antibody therapy for patients with high-risk muscle-invasive bladder cancer (MIBC), and consider the current role of this treatment strategy.
  • Recognize how biological and patient-specific factors influence the selection and sequencing of treatment for metastatic UBC.
  • Review available clinical trial evidence with immune checkpoint inhibitors as monotherapy or as maintenance after platinum-based chemotherapy in the treatment of newly diagnosed metastatic UBC, and determine the current utility of these agents in practice.
  • Appreciate the biological rationale for combining anti-PD-1/PD-L1 antibodies with chemotherapy or antibody-drug conjugates, and assess the current and future role of these regimens in the care of patients with previously untreated metastatic UBC.
  • Recall pivotal clinical trial findings leading to the FDA approval of novel compounds, such as antibody-drug conjugates and tyrosine kinase inhibitors, for previously treated locally advanced or metastatic UBC, and identify patients for whom treatment with these approaches would be appropriate.
  • Interrogate clinical trial findings with HER2-directed therapies for advanced UBC, and evaluate the future utility of these agents in the care of appropriately selected patients.
  • Implement a plan of care to recognize and manage side effects and toxicities associated with approved and emerging systemic therapies for metastatic UBC.
  • Develop an understanding of the biological rationale for, available research findings with and ongoing studies evaluating promising investigational agents and strategies for patients with NMIBC, MIBC and metastatic UBC.

CME Credit Form
A CME credit link will be given to each participant at the conclusion 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 2 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 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 conflicts of interest will 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. Financial disclosures will be provided prior to the program.

FACULTY — The following faculty reported relevant financial relationships with ineligible entities:

Dr MilowskyContracted Research: Accuray, Acrivon Therapeutics, ALX Oncology,Amgen Inc, Arvinas, Astellas, AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, Boehringer Ingelheim Pharmaceuticals Inc, Bristol Myers Squibb, Clovis Oncology, G1 Therapeutics Inc, Genentech, a member of the Roche Group, Incyte Corporation, Loxo Oncology Inc, a wholly owned subsidiary of Eli Lilly & Company, Merck, Mirati Therapeutics Inc, MorphoSys, Novartis, Seagen Inc; Nonrelevant Financial Relationship: Alliance for Clinical Trials in Oncology, Alliance Foundation Trials LLC, Elsevier (Co-Editor-in-Chief, Clinical Genitourinary Cancer), Hoosier Cancer Research Network Inc, Medscape, The Prostate Cancer Clinical Trials Consortium. Dr O'DonnellAdvisory Committee: Merck, Seagen Inc; Consulting Agreements: Adept Field Solutions, AmerisourceBergen, Astellas, Axiom Healthcare Strategies, Curio Science, Custom Learning Designs (CLD), EMD Serono Inc, Health Advances, Merck, Pfizer Inc, Seagen Inc, Vaniam Group, Vida Ventures LLC; Contracted Research (to Institution): Acerta Pharma — A member of the AstraZeneca Group, Astellas, AstraZeneca Pharmaceuticals LP, Boehringer Ingelheim Pharmaceuticals Inc, Bristol Myers Squibb, Genentech, a member of the Roche Group, Janssen Biotech Inc, Merck, Seagen Inc; Data and Safety Monitoring Board/Committee: Dragonfly Therapeutics, G1 Therapeutics Inc, Janssen Biotech Inc, Nektar; Sponsored Travel: Astellas, Curio Science, Seagen Inc; Nonrelevant Financial Relationship: Advarra, FirstWord Pharma, Great Debates & Updates, Hart Wagner LLP, IntrinsiQ Specialty Solutions, ISMIE, Med Learning Group, MJH Life Sciences, NAMCP, O’Brien & Ryan LLP, Parexel, PeerView, PharmaVision UK, PRIME Education LLC, The Institute for Enquiring Minds. Dr RosenbergAdvisory Committee: Astellas, Seagen Inc, Tyra Biosciences; Consulting Agreements: Aadi Bioscience, Alligator Bioscience, Astellas, AstraZeneca Pharmaceuticals LP, Boehringer Ingelheim Pharmaceuticals Inc, Bristol Myers Squibb, EMD Serono Inc, Emergence Therapeutics, Genentech, a member of the Roche Group, Gilead Sciences Inc, Imvax Inc, Infinity Pharmaceuticals Inc, Jiangsu Hengrui Medicine Co Ltd, Lilly, Merck, Mirati Therapeutics Inc, Pfizer Inc, QED Therapeutics, Seagen Inc, Tyra Biosciences; Contracted Research: Astellas, AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, Seagen Inc; Speakers Bureau: EMD Serono Inc, Pfizer Inc; Nonrelevant Financial Relationship: Clinical Care Options, Medscape, MJH Life Sciences. Dr Siefker-Radtke — No relevant conflicts of interest to disclose.

MODERATORDr YuConsulting Agreements: Aadi Bioscience, Advanced Accelerator Applications, Bayer HealthCare Pharmaceuticals, Janssen Biotech Inc, Merck, Oncternal Therapeutics; Contracted Research: Bayer HealthCare Pharmaceuticals, Blue Earth Diagnostics, Daiichi Sankyo Inc, Dendreon Pharmaceuticals Inc, Lantheus, Merck, Seagen Inc, Surface Oncology, Taiho Oncology Inc, Tyra Biosciences.

SURVEY PARTICIPANTS
Terence Friedlander, MDAdvisory Committees: Aadi Bioscience, Astellas, Seagen Inc; Consulting Agreement: Merck; Contracted Research: Bristol Myers Squibb, Roche Laboratories Inc, Seagen Inc, Trishula Therapeutics Inc; Data and Safety Monitoring Board/Committee: AstraZeneca Pharmaceuticals LP. Elizabeth R Plimack, MD, MSAdvisory Committees and Consulting Agreements: Astellas, AstraZeneca Pharmaceuticals LP, Eisai Inc, EMD Serono Inc, IMV Inc, Merck, Pfizer Inc, Seagen Inc, Synthekine; Contracted Research: Merck.

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 AstraZeneca Pharmaceuticals LP, Bristol Myers Squibb, Daiichi Sankyo Inc, and Janssen Biotech Inc, administered by Janssen Scientific Affairs LLC.

San Francisco Marriott Marquis
780 Mission Street
San Francisco, CA 94103
Hotel Phone: (415) 896-1600

Meeting Room
Golden Gate Ballroom — Salon A (B2 Level)

Directions
The San Francisco Marriott Marquis is located just 2 blocks (less than 0.2 miles) from the Moscone Center, where the 2024 ASCO Genitourinary Cancers Symposium is taking place.

 
This activity is intended for medical and radiation oncologists, urologists and other healthcare providers involved in the treatment of urothelial bladder cancer.

There is no registration fee for this event. For the in-person symposium in San Francisco, preregistration is required as seating is limited.

NOTICE:
Registration for this event is independent of registration for the 2024 ASCO Genitourinary Symposium.

IN-PERSON Registration for clinicians in practice/healthcare professionals

Thank you for your interest in our CME program. At this time online preregistration is closed for this eventSEATS ARE STILL AVAILABLE FOR THIS SESSIONOur onsite registration deskwill be open at 6:30 PM PT on Friday, January 26thsup>. If you are interested in attending, please visit our registration desk outside the Golden Gate Ballroom — Salon A (B2 Level) at the San Francisco Marriott Marquis hotel (780 Mission Street), within walking distance of the Moscone Convention Center (2 blocks). Please note: Seats will be offered on a first come, first served basis, and onsite registration does not guarantee participation in the meal service. Clinicians in practice will be prioritized for seating first.

If you have any questions, please feel free to contact us via email at Meetings@ResearchToPractice.com, or call (800) 233-6153. 

LIVE WEBCAST Registration for all professionals

Please note, we will stream this event over Zoom. After registering you will receive a separate confirmation from Zoom with the viewing instructions.

REGISTRATION FOR WEBCAST »
Registration for groups
If you are registering a group (more than 1 person) for this event, please contact us at Meetings@ResearchToPractice.com or (800) 233-6153.
To ensure seating and meal service, please check in at our onsite registration desk 15 minutes before the start of the meeting. We cannot guarantee seating after the start of the program.

Photography and/or video recording may be taken during the educational program by Research To Practice and used in future educational offerings.

Research To Practice fully complies with the legal requirements of the ADA. If you are in need of assistance (ie, physical, dietary, et cetera), please contact us prior to the event at (800) 233-6153.

Not an official event of the 2024 ASCO Genitourinary Cancers Symposium. Not sponsored, endorsed, or accredited by ASCO®, Association for Clinical Oncology, CancerLinQ®, or Conquer Cancer®, the ASCO Foundation.