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      Twitter: #OCEGynCancers18

Co-Sponsors: American Association for Cancer Research (AACR) and Society of Gynecologic Oncology (SGO)

Co-Chairs:

U.S. Food and Drug Administration

• Julia A. Beaver, MD
• Sanjeeve Balasubramaniam, MD, MPH

American Association for Cancer Research

• Deborah K. Armstrong, MD - Johns Hopkins Kimmel Comprehensive Cancer Center
• Gordon B. Mills, MD, PhD - UT MD Anderson Cancer Center

Society of Gynecologic Oncology

• Robert Coleman, MD, FACOG, FACS - UT MD Anderson Cancer Center
• Thomas Herzog, MD - University of Cincinnati Cancer Institute
• Rebecca Arend, MD - University of Alabama at Birmingham

Date:

June 14, 2018

Time:

8:00 am to 5:00 pm

Location:

FDA White Oak Campus
Building 31, Room 1503 - Great Room
10903 New Hampshire Avenue
Silver Spring, MD 20993

FDA Campus Information, (e.g., local airports, directions, and local hotels)

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Background:

Gynecologic malignancies continue to be a major cause of morbidity and mortality in the United States, resulting in an unmet medical need. In 2015, FDA held a public workshop to facilitate drug development in gynecologic malignancies, with a focus on ovarian cancer, where we covered topics including immunotherapy, novel clinical trial designs, novel endpoints, and expanded eligibility criteria. The impact of this workshop reached patients and clinicians, as well as pharmaceutical industry stakeholders who were in attendance. At this point, we can take advantage of the impact of that first workshop and continue to support the development of these treatment options.

Workshop Objectives:

• To provide a forum for open discussion between the FDA, clinicians, laboratory experts, and researchers on the way forward for diagnosis and treatment of gynecologic malignancies
• Accelerate the development of immunotherapy in gynecologic malignancies
• Facilitate open discussions in the area of gynecologic malignancies
• Obtain input from multiple stakeholders on approaches to novel study designs to leverage rare subtypes in gynecologic malignancies
• Discuss the impact of biomarkers in gynecologic malignancies

Webcast Information:

FDA will provide a free-of-charge, live webcast of this workshop.

• Session 1: https://collaboration.fda.gov/p7fmozotsb0/
• Session 2: https://collaboration.fda.gov/p7pk00hy6ar/
• Session 3: https://collaboration.fda.gov/p29vypq89te/
• Session 4: https://collaboration.fda.gov/p3nihtrkklr/

Meeting Information

Persons with disabilities having problems accessing the PDF file(s) below may call (301) 796-3634 for assistance.

SESSION I: DEVELOPMENT OF IMMUNOTHERAPY IN GYNECOLOGICAL MALIGNANCIES – PART 1
SESSION COCHAIRS: SANJEEVE BALA, MD, MPH, & THOMAS HERZOG, MD
Description: To discuss the science behind why immunotherapy would work in GYN malignancies and biomarker issues associated with immunotherapy.

Immunotherapy for Gynecologic Cancers: What is the Biological Rationale for, and Challenge of Immunotherapy for Gynecologic Cancer? (PDF - 10 MB)
Dmitriy Zamarin, MD, PhD
Memorial Sloan Kettering Cancer Center

Efficacy/Safety of Single Agent Immunotherapy/Immune Checkpoint Inhibitors in Gynecologic Cancer (PDF -  2 MB)
Deborah K. Armstrong, MD
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

Strategy, Efficacy, and Safety of Combination Regimens Using Immunotherapy (PDF - 739 KB)
Rebecca Arend, MD
University of Alabama at Birmingham

SESSION II: DEVELOPMENT OF IMMUNOTHERAPY IN GYNECOLOGICAL MALIGNANCIES – PART 2
SESSION COCHAIRS: JULIA A. BEAVER, MD, & REBECCA AREND, MD
Description: To discuss innovative study design ideas to examine contribution of effect of novel immunotherapy combinations in GYN malignancies.

Novel Immunotherapy Approaches and Cellular-based Therapy for Gynecologic Oncology Patients (PDF - 2 MB)
Amir A. Jazaeri, MD
UT MD Anderson Cancer Center

Innovations in Immuno-oncology Clinical Trial Designs (PDF - 2.5 MB)
Robert L. Coleman, MD, FACOG, FACS
UT MD Anderson Cancer Center

Statistical Considerations for Immuno-oncology Trials (PDF - 325 KB)
Rajeshwari Sridhara, PhD
U.S. Food and Drug Administration

SESSION III: BIOMARKER DEVELOPMENT AND PARP INHIBITORS
SESSION COCHAIRS: DEBORAH K. ARMSTRONG, MD, & ROBERT L. COLEMAN, MD, FACOG, FACS
Description: Given the recent approvals of PARP inhibitors in the BRCA unselected patients, how can we better predict who will respond to these drugs since only a small percentage of BRCA negative group will do so? How can we identify that group?

FDA Perspective
Gwynn Ison, MD
U.S Food and Drug Administration

PARP Resistance Mechanisms (Presentation not available)
Alan D’Andrea, MD
Dana-Farber Cancer Institute

Rational Drug Combinations with PARP Inhibitors (PDF - 2 MB)
Gordon B. Mills, MD, PhD
UT MD Anderson Cancer Center

SESSION IV: DEVELOPMENT OF DRUGS FOR RARE GYNECOLOGICAL MALIGNANCIES
SESSION COCHAIR: GORDON B. MILLS, MD, PHD
Description: Development of drugs for rare GYN malignancy subset (e.g. clear cell ovarian cancer); this session will explore trouble with control arms, small sample sizes, need for more real world historic controls and single arm studies, vs. small cohorts within randomized trials.

Emerging Opportunities in Rare Gynecologic Cancers (PDF - 2 MB)
Anil K. Sood, MD
UT MD Anderson Cancer Center

The Challenge of Rare Subsets of Rare Cancers: A focus on ESR1 mutations in gynecologic malignancies (PDF - 2 MB)
Stephanie L. Gaillard, MD, PhD
Johns Hopkins School of Medicine

Progress in Drug Development for Rare Epithelial Ovarian Cancers: The NRG Oncology (GOG) Experience PDF - 625)
David M. Gershenson, MD
UT MD Anderson Cancer Center

Contact:

Sherwin Sapasap, MS, MBA, MHA
Center for Drug Evaluation and Research
Office of New Drugs
Office of Hematology and Oncology Products
[email protected]