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Comprehensive roadmap promises to improve cancer immunotherapy development

September 19, 2017

???A new paradigm for clinical development that incorporates knowledge of the unique characteristics of immunotherapies and proposes several considerations for clinical trial design that will enable better evaluation of their therapeutic efficacy.???International initiatives to harmonize immune monitoring assays to increase the quality of immunological monitoring across the field and enable meaningful aggregation and comparison of immune monitoring data, which will significantly enhance understanding of cancer immunotherapies' mechanisms of action and facilitate the identification and validation of biomarkers that may help predict clinical outcomes.???Improved study designs and clinical endpoints that better reflect the biology and time course of cancer immunotherapies and will enable a more accurate and robust analysis of therapeutic efficacy.???Immune-related response criteria (irRC) that, while based on conventional response criteria, allow for a broader spectrum of responses observed in patients treated with cancer immunotherapies, including initial tumor progression or the appearance of new lesions. These criteria provide more comprehensive guidance to demonstrate and evaluate clinical activity in cancer immunotherapy clinical trials.???A framework for reporting minimally required clinical immune monitoring data openly and uniformly in academic publications, allowing researchers to interpret and compare data across clinical trials, enhancing the reproducibility of assays and results, and further supporting ongoing efforts to identify and validate biomarkers correlating with clinical outcomes.???The development of guidance documents by regulatory authorities, such as the U.S. Food and Drug Administration and the European Medicines Agency, that can provide cancer immunotherapy developers with a clear understanding of the criteria such agencies will use to judge clinical efficacy of cancer immunotherapies, including therapeutic cancer vaccines, and trial considerations that will enable developers to best demonstrate efficacy and meet these criteria as the basis for market approval.

According to Cedrik M. Britten, M.D., CIMT executive director of translational medicine and co-author on the paper, this new framework for immune-oncology was only made possible by intensive trans-continental cooperation among networks with unique expertise in the fields of technology, immunology, oncology, industrial drug development, and regulatory aspects.

"Developing new treatments to address the huge unmet medical need in oncology is a global challenge," says Britten. "Fortunately, we have reached a deeper understanding of the peculiar features of immune therapies, and we now have the tools to make the next leap forward toward more effective immunotherapies and their broader use."

Source: Nature Biotechnology