On Wednesday, Merck (MRK) was notified by the FDA that it was hit with a clinical hold on three multiple myeloma studies that were treating patients with Keytruda. The reason for the hold was that there were more patients deaths reported in the studies. These trials are treating patients with multiple myeloma using a combination of Keytruda and other compounds.
Combo Treatment Problem
About a month ago Merck had stopped enrollment in two phase 3 multiple myeloma studies. Those studies were testing Keytruda in combination with Celgene (NASDAQ:CELG) drugs. The decision to pause enrollment in the studies came from a safety monitoring board. The board determined that there were more patient deaths in the combination studies with Keytruda, than in the control groups. Enrollment being paused was a huge blow to Merck, but not as bad as the clinical hold itself. The FDA placed a clinical hold on three multiple myeloma trails due to patient deaths. The bad news is that all the patients in these multiple myeloma trials that were taking the combo treatment will no longer receive Keytruda. This is a setback for Merck, but there is a bright side to this story. The good news is that none of the other clinical trials dealing with Keytruda have been affected. Keytruda is currently being tested in hundreds of other clinical trials in combination with other cancer drugs. There is no guarantee, but one can conclude that this treatment combination might be the culprit in the patient deaths. Anyways, that is what the FDA will try to parse through to determine the cause of the patient deaths.