Merck pauses enrollment in Keytruda's Phase III studies

Merck has paused enrollment in two Keytruda clinical trials.

Merck paused enrollment in the Keynote-183 and Keynote-185 Phase III trials after the external Data Monitoring Committee made the recommendation. Additional information will be collected regarding reports of deaths in the Keytruda (pembrolizumab) groups while participants in the two studies will continue their treatments. 

Other Keytruda studies are not affected by the pause in the multiple myeloma studies.

Both Keynote studies are comparing combination treatments using Keytruda and other therapies in treating multiple myeloma. Keynote-183 is evaluating a combination of Keytruda with pomalidomide and low-dose dexamethasone to pomalidomide and low-dose dexamethasone alone. The participants have refractory or relapsed and refractory multiple myeloma and have had two or more prior treatments.

Keynote-185 enrolled patients with newly diagnosed and treatment naïve multiple myeloma. The participants are not eligible for autologous stem cell transplant (Auto-SCT). The study is comparing Keytruda with lenalidomide and low-dose dexamethasone to lenalidomide and low-dose dexamethasone alone.

Keytruda indicated for use in treating melanoma. It is also approved under accelerated approval for classical Hodgkin lymphoma, head and neck cancer, lung cancer, microsatellite instability-high cancer and urothelial carcinoma.