Merck announced that it is postponing enrollment in the phase III KEYNOTE-183 and KEYNOTE-185 trials because of deaths in patients with multiple myeloma assigned to pembrolizumab (Keytruda), the company’s blockbuster anti–PD-1 therapy.
The FDA first approved pembrolizumab for the treatment of advanced or unresectable melanoma in 2014. The PD-1 inhibitor is approved for unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors that have progressed and for whom there are no alternative treatment options, making it the first tissue/site agnostic cancer treatment in the United States. The drug has also been approved for lung cancer, head and neck cancer, Hodgkin lymphoma, and urothelial carcinoma.
Badros AZ, Hyjek E, Ma N, et al. Pembrolizumab in Combination with Pomalidomide and Dexamethasone for Relapsed/Refractory Multiple Myeloma (RRMM). Presented at: 58th ASH Annual Meeting and Exposition; San Diego, California; December 2-6, 2016. Abstract 490.
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