7:17 PM
Nov 16, 2018
 |  BioCentury  |  Product Development

Rethinking RECIST for immunotherapies

How companies, FNIH are working to find new IO response criteria

Momentum is growing for new tumor response criteria that better reflect the benefits of cancer immunotherapies, with FNIH, companies and FDA all pushing for validation of these criteria.

At a Nov. 9 workshop co-hosted by the Society for Immunotherapy of Cancer (SITC) and FDA, the agency highlighted its concerns over the possibility that benefits of immunotherapies aren’t fully captured by existing RECIST 1.1 criteria, and what it would like to see companies do to test new criteria.

The goal is to find readouts for cancer immunotherapies that more accurately reflect how they work than standard criteria, and avoid shelving potentially active compounds because their benefit has been missed. The need is further heightened as immunotherapies move into studies in first-line metastatic and adjuvant settings, where absent new criteria, trials could need to be much longer to measure the most obvious benefit of survival.

“We thought it was a good time, with the wide changing standard of care towards transformative immuno-oncology products across many therapeutic areas, to discuss immune-based criteria and the potential for these to serve as the primary evidence to support approval,” said Marc Theoret, associate director for immunotherapeutics in the Office of Hematology and Oncology Products at FDA.

Standard response criteria in cancer clinical trials, such as RECIST and WHO, do not take into consideration the late onset of response often seen with the checkpoint inhibitor anti-PD-1/PD-L1 or anti-CTLA-4 mAbs. The reason is that they automatically score an increase in the size...

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