Merck has announced that they will not be enrolling any new patients into two Phase III clinical trials involving Keytruda (pembrolizumab) following reports of patient deaths. The decision was made based on an external data monitoring committee’s recommendation.
“The pause is to allow for additional information to be collected to better understand more reports of death in the Keytruda groups,” said Merck in a press release. “Patients currently enrolled in these two studies will continue to receive treatment.”
Both the KEYNOTE-183 and KEYNOTE-185 clinical trials were testing Keytruda treatment in combination with other therapies in patients with multiple myeloma. Keytruda has already been approved for a number of indications, including treatment of melanoma, lung cancer and Hodgkin lymphoma.
The KEYNOTE-183 clinical trial is assessing a combo treatment involving pomalidomide, low-dose dexamethasone and Keytruda. In addition to low-dose dexamethasone, the KEYNOTE-185 clinical trial is testing a combo of lenalidomide and Keytruda.
Keytruda is an anti-PD-L1 immunotherapy that supports the patient’s immune system in destroying cancer cells. The checkpoint inhibitor has not shown these types of safety issues in previous clinical trials.
The FDA recently approved Keytruda to treat patients whose cancer has the MSI-H biomarker, regardless of the tumor’s tissue of origin. The biomarker has been identified in multiple cancer types, including endometrial, colorectal and gastrointestinal tumors.