The FDA has put on hold three clinical trials involving the immunotherapy pembrolizumab (Keytruda) in combination with other therapies for multiple myeloma, following patient deaths.
The US Food and Drug Administration placed two phase III trials on ‘clinical hold’, and a third trial on ‘partial clinical hold’, with the move coming after a data monitoring committee noted more deaths in the Keytruda arms of the trials.
One trial was investigating pomalidomide (Imnovid) and low-dose dexamethasone with or without pembrolizumab in refractory or relapsed and refractory multiple myeloma, and had an estimated 300 participants.
The other looked at lenalidomide (Revlimid) and low-dose dexamethasone with or without pembrolizumab in newly diagnosed and treatment naïve multiple myeloma, with about 640 participants.
Both trials began in October 2015.
“The FDA has determined that the data available at the present time indicate that the risks of Keytruda plus pomalidomide or lenalidomide outweigh any potential benefit for patients with multiple myeloma,” Merck said in a statement on 5 July.
The partial hold applies to a phase I multi-cohort trial of pembrolizumab in combination with backbone treatments for patients with multiple myeloma.
Merck would not provide details on the number of deaths, with a spokeswoman telling the limbic the company “will perform a complete analysis of all data in these trials and present the results at an upcoming scientific meeting”.
“MSD will continue to closely monitor the safety of Keytruda across all trials,” she said.
In Australia pembrolizumab is indicated for unresectable or metastatic melanoma in adults, metastatic non-small cell lung carcinoma and recurrent or metastatic head and neck squamous cell carcinoma.
The product information for Keytruda is available here