FDA halts recruitment to three BMS Opdivo trials

The FDA has halted recruitment to three blood cancer trials involving Bristol-Myers Squibb’s Opdivo because of risks identified in similar trials of Merck & Co’s rival drug, Keytruda.

BMS said the regulator placed a partial clinical hold on the CheckMate-602, CheckMate-039 and CA204142 trials investigating combinations of Opdivo in patients with relapsed or refractory multiple myeloma.

While recruitment has stopped, patients currently being dosed can continue with their therapy.

The FDA took action after it put two trials of Merck & Co’s Keytruda PD-1 rival on hold in June because of excess deaths.

Other trials could also be affected too – the FDA said at the beginning of the month that it will investigate safety of trials involving other PD-1 and PD-L1 inhibitors, in combination with other drugs, in blood cancer.

In the KEYNOTE-183 and KEYNOTE-185 trials, Keytruda was used in combination with an immunomodulatory agent such as Celgene’s Revlimid (lenalidomide) and Imnovid (pomalidomide) for multiple myeloma.

Data from other studies indicate risks of treatment with PD-1/PD-L1 plus pomalidomide or lenalidomide could outweigh any benefits for patients with this disease, the FDA said.

The affected trials are:

CheckMate-602, which is an open-label, randomised phase 3 trial of combinations of Opdivo, BMS’ Empliciti (elotuzumab), pomalidomide and dexamethasone in relapsed and refractory multiple myeloma.

CheckMate-039, a phase 1 study to establish the tolerability of Opdivo and the combination of Opdivo and Janssen’s Darzalex (daratumumab), with or without IMiD (pomalidomide and dexamethasone), in subjects with relapsed or refractory multiple myeloma.

And CA204142, a phase 2, multiple cohort study of Empliciti plus pomalidomide and low-dose dexamethasone, and in combination with Opdivo, in patients with multiple myeloma relapsed or failed to respond to treatment with lenalidomide.

Other studies of Opdivo outside multiple myeloma will continue as planned. Empliciti is already approved in combination with lenalidomide and dexamethasone in heavily pretreated multiple myeloma patients.

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