Merck is testing Keytruda in combinations with Celgene’s Revlimid and Pomalyst as a treatment for multiple myeloma. After an onslaught of what was said to be good trial results and regulatory news, drug maker Merck announced on June 12 that it was halting enrollment on a pair of phase 3 multiple myeloma studies of the drug to investigate trial deaths.
The move, which comes at the recommendation of an independent data monitoring committee, came after “more reports of death” in the Keytruda groups of studies Keynote-183, which is examining a combo of Keytruda with Celgene’s Pomalyst and dexamethasone in previously treated patients, and Keynote-185, which is combining Keytruda with Celgene’s Revlimid in certain not-yet-treated patients.
Patients already enrolled in those trials will continue to receive treatment, according to Merck. The company told Credit Suisse analyst Vamil Divan that “this is not a clinical hold.” Nevertheless, it deals with deaths that occurred during the trials.
At press time, there were a number of unanswered questions. For example, Merck had not revealed how many patients have died. Neither is it known whether investigators observed the imbalance in just one study or both, Divan wrote in a note to clients on June 12.
It was said by the Credit Suisse analyst that the “dearth of information” makes it “difficult to draw meaningful conclusions.” Nevertheless, Divan said she is not worried about the situation, stating: “We don’t believe there is anything of major concern here at this time.”
In the weeks leading up to the conference, Keytruda picked up three U.S. Food and Drug Administration (FDA) approvals – as part of a front-line lung cancer chemo combo, in bladder cancer, and in microsatellite instability-high cancer – as well as a priority review in stomach cancer. This is a situation where the drug maker and the FDA must be absolutely certain that Keytruda is a safe drug.
Contact us today for a free legal consultation with an experienced attorney.
Fields marked *may be required for submission.
If you would like to subscribe to the Jere Beasley Report digital edition, simply visit our Subscriptions page and provide the necessary information or call us at 800-898-2034.
Attorney Advertising - Prior results do not guarantee a similar outcome.