Merck announced that the Food and Drug Administration (FDA) has placed a clinical hold on three studies evaluating Keytruda (pembrolizumab) for the treatment of multiple myeloma. 

The decision was made following a review of data which exhibited more deaths in the Keytruda arms of KEYNOTE-183 and -185; this led to a pause in new patient enrollment. Currently available study data demonstrate that the risks of Keytruda in combination with pomalidomide or lenalidomide outweigh any potential benefit for patients with multiple myeloma.

A full clinical hold has been placed on KEYNOTE-183 and KEYNOTE-185, and a partial clinical hold has been placed on KEYNOTE-023 Cohort 1. As a result, all study patients will stop treatment with Keytruda.  

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KEYNOTE-183 was a Phase 3 study evaluating pomalidomide and low-dose dexamethasone with or without Keytruda in patients with refractory or relapsed multiple myeloma. KEYNOTE-185 was a Phase 3 study  evaluating lenalidomide and low-dose dexamethasone with or without Keytruda in patients with newly diagnosed and treatment-naive multiple myeloma. KEYNOTE-023 Cohort 1 was a Phase 1 multi-cohort trial evaluating Keytruda in combination with backbone treatments for patients with multiple myeloma; Cohort 1 specifically looked at Keytruda in combination with lenalidomide and dexamethasone in patients who had prior multiple myeloma therapy with an immunomodulator (eg, lenalidomide, pomalidomide, thalidomide). 

Keytruda, an anti-PD-1 agent, is currently approved to treat various cancers including melanoma, non-small cell lung cancer (NSCLC), head and neck cancer, classical Hodgkin lymphoma, urothelial carcinoma, and microsatellite instability-high cancer. 

Keytruda is available as a lyophilized powder for injection in 50mg single-dose vials, and as a solution for injection in 100mg/4mL single-dose vials. 

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