ODAC calls for major change to perioperative checkpoint inhibitor studies

Companies devising clinical development strategies for checkpoint inhibitors in the highly competitive perioperative treatment setting will need to reconsider their late-stage trial designs, according to FDA’s Oncologic Drugs Advisory committee.

Last week, the committee agreed that the traditional two-arm randomized trial design isn’t sufficient to support future perioperative applications of checkpoint inhibitor therapies in non-small cell lung cancer (NSCLC). It urged companies to get creative with trial designs, or take on the larger, more lengthy multi-arm trials that can fill holes in the data...