(Credit: A 4)
Bristol-Myers Squibb provides an update on three Opdivo-based combination clinical studies in multiple myeloma.
The U.S. Food and Drug Administration (FDA) has placed a partial clinical hold on CA209602 (CheckMate-602), CA209039 (CheckMate-039) and CA204142, three clinical trials investigating Opdivo (nivolumab)-based combinations in patients with relapsed or refractory multiple myeloma.
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.
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 following trials are on partial clinical hold:
- CheckMate-602: An Open-Label, Randomized Phase 3 Trial of Combinations of Nivolumab, Elotuzumab, Pomalidomide and Dexamethasone in Relapsed and Refractory Multiple Myeloma
- CheckMate-039: A Phase 1 study to establish the tolerability of nivolumab and the combination of nivolumab and daratumumab, with or without IMiD (pomalidomide and dexamethasone), in subjects with relapsed or refractory MM
- CA204142: A Phase 2, Multiple Cohort Study of Elotuzumab in Combination With Pomalidomide and Low-Dose Dexamethasone (EPd), and in Combination With Nivolumab (EN), in Patients With Multiple Myeloma Relapsed or Refractory to Prior Treatment With Lenalidomide
Other studies of Opdivo outside of multiple myeloma will continue as planned. Empliciti (elotuzumab) is approved in the U.S. in combination with lenalidomide and dexamethasone, for the treatment of patients with multiple myeloma who have received one to three prior therapies
(Source: Bristol-Myers Squibb)
