For more information, contact:
Angela Kilbert, Associate Director of Education and Meetings
International Society for Biological Therapy of Cancer
555 E Wells St, Suite 1100, Milwaukee, WI 53202
Phone: 414-271-2456 • Fax: 414-276-3349
Email: akilbert@sitc.org
Website: www.sitcancer.org
For Immediate Release
THE FUTURE/FATE OF AGENTS TARGETING CTLA4: A "HOT TOPIC" AT THE SITC ANNUAL MEETING
SAN DIEGO---The International Society for Biological Therapy of Cancer (SITC) symposium entitled the "Anti-CTLA-4: Issues in Development and Regulatory Approval," was held on November 2, 2008 as part of the society's 23rd Annual Meeting. The symposium featured discussions of the efficacy results and development strategies for two antibodies targeting the immune checkpoint molecule CTLA4 relative to other agents, especially interleukin 2, and the pathways and potential for their achieving regulatory approval.
This SITC-initiated forum provided a venue for prominent cancer investigators from around the world to discuss complex clinical outcome issues surrounding tumor response after initial progression, durable response ("tail of the curve") in small subsets of patients without other treatment options, the possibility of "clinical benefit" without classical objective tumor response and the potential for identification and selection of patients most likely to experience benefit from this treatment.
The session co-chairs and former SITC presidents, Michael B. Atkins, MD, of Beth Israel Deaconess Medical Center (Boston, MA) and Ulrich Keilholz, MD, of Charité (Berlin, Germany), were encouraged by the dialogue that occurred as a result of this program regarding the possibility of establishing the merits of these agents and potentially other novel immunotherapeutic agents using existing definitions of efficacy.
"CTLA4 blockade is a promising approach for the treatment of advanced melanoma," stated Michael Atkins, MD, session co-chair. "Data presented at the Hot Topic Symposium at the SITC Annual Meeting suggests that this approach produces sustained tumor shrinkage in between 5 and 10% of patients and may very well improve median overall survival. The aggregate of data was felt by the experts on the panel to define potential paths to FDA approval for this new class of immunotherapies. The availability of these agents not only provides hope for our patients, but also will likely be the cornerstone of combination immunotherapy strategies."
Ultimately, the fate of these agents will depend on the long-term outcome data from ongoing pivotal trials with these agents.
Cancer investigators attending the symposium engaged in the lively discussions and received information that should influence the design and implementation of their own research including preclinical and clinical development of immunological agents and biomarkers. This extends into patient benefit, optimal endpoints for single agent trials, design and conduct of enrichment studies and steps to combination therapy that are all deemed to be critical to the development of active immunotherapies.
Faculty members and panel discussion participants included:
More information on this and other SITC programs can be found on the society website, www.sitcancer.org.
Founded in 1984, the International Society for Biological Therapy of Cancer (SITC) is a non-profit organization of clinicians, researchers, students, post-doctoral fellows, and allied health professionals dedicated to improving cancer patient outcomes by advancing the development and application of biological therapy. Scientists from academia, industry and the regulatory arena come together under the umbrella of SITC in order to facilitate the rapid dissemination of information on clinical and translational aspects of biologic approaches to cancer treatment to expedite the safe transfer of both basic and applied research to the clinical setting.
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