FDA puts on hold three Opdivo-based combination studies in multiple myeloma

The U.S. Food and Drug Administration (FDA) has placed a partial clinical hold on three Opdivo-based combination clinical studies in multiple myeloma.

Bristol-Myers Squib said on Wednesday that this partial clinical hold is related to risks identified in trials studying another anti–PD-1 agent, pembrolizumab, in patients with multiple myeloma. The FDA determined data currently available from non-Opdivo studies indicate the risks of PD-1/PD-L1 treatment plus pomalidomide or lenalidomide and possibly PD-1/PD-L1 treatments alone or with other combinations outweigh potential benefit for patients with multiple myeloma.

As part of the terms of the partial clinical hold, patients currently enrolled in CheckMate-602, CheckMate-039 and CA204142 who are experiencing clinical benefit can continue treatment. No new patients will enroll in the studies at this time, BMS said.

“Bristol-Myers Squibb remains steadfast in our commitment to improve outcomes for patients with multiple myeloma, and will work closely with the FDA to address concerns,” the company’s press release reads.

BMS said that other studies of Opdivo outside of multiple myeloma will continue as planned.