Sunday Hot Topic Symposium
Anti-CTLA-4:
Issues in Development and Regulatory Approval
November 2, 2008
Westin Gaslamp Quarter Hotel
San Diego, CA
Following the conclusion of the iSBTc Annual Meeting, iSBTc hosted a hot topic symposium entitled, "Anti-CTLA-4: Issues in Development and Regulatory Approval." The 1.5 hour program featured invited speakers focusing on panel discussion and audience question and debate.
Program Goals
- Describe and discuss the development strategies for two antibodies aiming at the same immune checkpoint molecule CTLA4 and the current status of these agents in comparison to the experience interleukin-2.
- Create a forum to discuss complex clinical outcome issues such as tumor response after initial progression, durable response ("tail of the curve") in small subsets of patients without other treatment options, selection of responding patients that are commonly seen with active immunotherapies.
- Discuss regulatory issues including the definition of patient benefit, optimal endpoints for single agent trials, design and conduct of enrichment studies and steps to combination therapy that are critical to the development of active immunotherapies.
- Educate those new to the ISBTC community- students, faculty and industry representatives- regarding clinical development issues and strategies for immunologic agents.
Expected Learner Outcomes
After attending the symposium, participants will be able to:
- Summarize the current results of clinical developments of anti-CTLA4 antibodies.
- Understand the complexity of regulatory issues and definition of outcome measures in cancer clinical trials utilizing biologicals.
- Improve the design and implementation of their own research-aimed preclinical or clinical development of immunological agents and biomarkers.
Organizers
Michael B. Atkins, MD
Beth Israel Deaconess Medical Center
Bernard A. Fox, PhD
Earle A. Chiles Research Institute
Ulrich Keilholz, MD
Charité CBF
Mario Sznol, MD
Yale University School of Medicine
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Co-Chairs
Michael B. Atkins, MD
Beth Israel Deaconess Medical Center
Ulrich Keilholz, MD
Charité CBF
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