FDA lifts partial clinical hold on CheckMate-602 trial in MM

The US Food and Drug Administration has lifted a partial clinical hold placed on CA209-602 (CheckMate-602), a randomized, open-label Phase III study evaluating the addition of Opdivo (nivolumab) to pomalidomide and dexamethasone in patients with relapsed or refractory multiple myeloma (MM), being conducted by US pharma major Bristol-Myers Squibb (NYSE: BMY).

The decision follows consultation with the FDA and agreement on amendments to the study protocol, stated the company, whose shares rose nearly 1% to $53.40 on the news Friday.

Three trials evaluating Opdivo-based combinationsin relapsed or refractory multiple myeloma were placed on partial clinical hold in September 2017 as an FDA precaution following risks identified in trials studying another anti–PD-1 agent, pembrolizumab (Merck & Co Keytruda), in patients with multiple myeloma.