Bristol-Myers Squibb announced that the FDA has placed a clinical hold on 3 combination trials evaluating its programmed death-1 inhibitor nivolumab (Opdivo) in patients with relapsed/refractory multiple myeloma.
In a press release late Wednesday, Bristol-Myers Squibb (BMS) announced that the FDA has placed a clinical hold on 3 combination trials evaluating its programmed death-1 (PD-1) inhibitor nivolumab (Opdivo) in patients with relapsed/refractory multiple myeloma.
The hold, according to the company, is in reaction to trials evaluating another anti—PD-1 agent, pembrolizumab (Keytruda), that were placed on hold following patient deaths. In July, Merck, which has developed pembrolizumab, announced that the FDA’s decision applied to KEYNOTE-183, KEYNOTE-185, and KEYNOTE-023; the trials were evaluating the drug in combination with various other agents in either treatment-naïve or relapsed/refractory patients with multiple myeloma.
Earlier this week, the FDA followed up with a more detailed analysis of what resulted in the deaths—higher rate of grade 3 to 5 toxicities, higher rate of serious adverse events, and some non-cancer causes of death, including cardiac events and intestinal ischemia.
Nivolumab trials that have been placed on partial clinical hold include:
Other nivolumab studies for indications other than multiple myeloma will continue as planned, according to the BMS release.