After patient deaths cropped up in multiple myeloma studies featuring Merck’s Keytruda, the FDA isn’t taking any chances with the med’s rival, Bristol-Myers Squibb’s Opdivo.
On Wednesday, the agency placed a partial clinical hold on three studies testing the med alongside Celgene’s Revlimid (lenalidomide) or Pomalyst (pomalidomide)—the same meds used in the three affected Keytruda studies—for patients with relapsed or refractory forms of the disease, the New Jersey drug giant said.
“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,” it added.
The partial hold will hit the phase 3 CheckMate-602 trial, which groups Opdivo and Pomalyst with BMS and AbbVie med Empliciti and chemo dexamethasone; the phase 1 CheckMate-039 trial, which looks at both solo Opdivo and Opdivo-plus-Johnson & Johnson’s Darzalex with or without Pomalyst and dexamethasone; and the phase 2 CA204142 trial, which examines Empliciti matched up with Pomalyst and dexamethasone—and with Opdivo—in relapsed patients who haven’t received Revlimid.
For now, patients currently taking part in the trio of Bristol-Myers trials can continue with the regimens, as long as they’re experiencing clinical benefit, the FDA said. But no new patients can enroll in the studies. Other, non-myeloma Opdivo studies will continue as planned, regulators said.
The PD-1/PD-L1-Celgene marriages first prompted action in June, when Merck paused enrollment on the Keynote-183 and Keynote-185 studies to investigate trial deaths. The following month, after a data review that signaled the Keytruda regimens in question increased patients’ risk of death, the FDA discontinued the studies altogether, and it put out a public warning last week to healthcare professionals, clinical investigators and others about the risks associated with the pairings.
As analysts pointed out in June, the hurdle wouldn’t put any major dent in Keytruda’s sales potential. But the new FDA action does hurt Bristol-Myers’ ability to pick up ground on its rival, which vaulted ahead in the market race with two big first-line lung cancer approvals.