Federal health officials have placed a hold on three clinical trials designed to test the combination of advanced lung cancer treatments with various other forms of cancer drugs for treatment of multiple myeloma, after reports of several patient deaths with a similar drug.
Bristol-Myers Squibb issued a press release on September 6, announcing that the FDA has halted the studyes that were testing Opdivo in conjunction with Celgene’s Revlimid or Pomalyst medications, which are the same medications used in conjunction with Keytruda multiple myeloma studies that resulted in several patient deaths. Opdivo and Keytruda are similar, competing cancer drugs known as immune checkpoint inhibitors.
Multiple myeloma is a form blood cancer related to lymphoma and leukemia, in which Merck’s Keytruda and Bristol-Myers Squibb’s Opdivo were being tested in separate clinical trials, pairing them with the chemotherapy drug dexamethasone and either Celgene’s Revlimid or Pomalyst, as a potential new form of treatment.
Following patient deaths in two Keytruda clinical studies, the FDA halted any further advancement and new patient registration for both companies, out of an abundance of caution. The agency said the risks of severe adverse events, including death, appeared to outweigh any benefits of using the drug combinations to treat multiple myeloma. The Opdivo trials are being halted due to the close similarities between Keytruda and Opdivo.
The FDA is ordering patients currently taking part in the Opdivo trials to continue with the regimens, as long as they are experiencing clinical benefit. However, no new patients can enroll in the studies.
Opdivo studies affected by the FDA’s decision include CheckMate-602, CheckMate-039, and CA204142.
The FDA previously issued a safety alert for two Keytruda studies on August 31, 2017 after finding the medication used in combination with some other medications to treat multiple myeloma may be deadly for some patients.
The FDA warning came after data from the KEYNOTE-183 trial, which involved about 250 patients, indicated that patients given Keytruda had a 61% increased risk of death, with 29 deaths in the Keytruda arm of the clinical trial, compared to only 21 deaths among the control subjects.
Furthermore, the Keytruda KEYNOTE-185 clinical trial, involving about 300 patients, saw an even higher risk, with more than twice as many Keytruda patients dying than those in the control group, 19 to 9. That trial also showed that 54% of the patients given a Keytruda-based drug combination had a 54% chance of severe adverse health effects, compared to only 39% in the control group.
The FDA is asking healthcare professionals and patients who experience any adverse events or side effects during Keytruda treatment to report them to the FDA’s MedWatch Adverse Event Reporting Program.