CIC proposes criteria to improve endpoints for cancer immunotherapy trials

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The Cancer Research Institute (CRI) Cancer Immunotherapy Consortium (CIC), the leading global initiative in advancing the emerging field of immuno-oncology, has proposed criteria for improved endpoints for cancer immunotherapy trials, which were published online on September 8 in the Journal of the National Cancer Institute.

These improved clinical trial endpoints help to distinguish between the effects of chemotherapy and immunotherapy and address long-needed adjustments of standard endpoints such as survival and anti-tumor response. In addition, they introduce harmonization criteria for immune response assays to help establish immune response as a biomarker in clinical trials.

Over the last six years, the CIC has worked across the community of scientists involved with cancer immunotherapy within academia, industry, and regulatory agencies, and has developed these trial endpoint recommendations based on consensus workshops and clinical and laboratory data. Through these ongoing initiatives, the CIC facilitates progress in the field of immuno-oncology and gets closer to fulfilling its mission of making cancer immunotherapies part of the standard of care in oncology.

Axel Hoos, M.D., Ph.D., co-chairman of the CRI Cancer Immunotherapy Consortium Executive Committee and the primary author of the article, says that the adjusted clinical trial endpoints as proposed in the article better account for the clinical kinetics of cancer immunotherapies and could help investigators better evaluate their clinical effectiveness.

"A series of broad initiatives undertaken by the CRI Cancer Immunotherapy Consortium and partnering organizations between 2004 and 2009 have resulted in a new development paradigm encompassing improved clinical trial endpoints," Hoos says. "These recommendations included new immune-related response criteria (irRC), which we put forth in an article published in the journal Clinical Cancer Research in 2009 and which may lead to broader recognition of immunotherapeutic activity in early clinical studies.

Unlike chemotherapies, which act directly and rapidly on tumors, many cancer immunotherapies in development today aim to activate patients' immune systems, with the goal of mobilizing the body's natural defenses to search for, recognize, and eliminate target cancer cells. Considering the time it takes for treatment-induced immunologic responses to translate into clinical activity, the survival of patients may not be affected until some months after treatment started, says Hoos, adding that the kinetics observed for survival may require new statistical approaches for planning randomized trials.

"Overall survival rather than progression-free survival and radiographic response rate is becoming the 'gold standard' of clinical efficacy in cancer immunotherapy trials," says Cancer Research Institute clinical investigator and Scientific Advisory Council member Jedd D. Wolchok, M.D., Ph.D., associate director of the Ludwig Center for Cancer Immunotherapy and director of immunotherapy clinical trials at Memorial Sloan-Kettering Cancer Center in New York and a coauthor on the JNCI review article.

With the JNCI article, the CRI Cancer Immunotherapy Consortium continues to provide high-quality practical recommendations for the growing immuno-oncology community, and offers long-needed new tools to help chart a path for the successful development of cancer immunotherapies.

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