Health Care

Halts Enrollment in Two Keytruda Trials, Citing Deaths

The pause in recruitment follows an external Data Monitoring Committee making the recommendation based on a review of the data showing an increased number of deaths observed in the clinical studies.

Merck & Co said on Monday it paused enrolments in two late-stage studies testing its immunotherapy drug Keytruda used in combination with other therapies to treat multiple myeloma, a type of blood cancer. The trials involve combinations with Celgene's Pomalyst as well as its flagship drug Revlimid in a field Celgene dominates in.

Merck shares were down 1 percent to $63.75 in trading after the markets close in NY.

Keynote-183 is examining a regimen combining Keytruda, low-dose dexamethasone and Celgene's Pomalyst (pomalidomide) in patients with relapsed or refractory multiple myeloma.

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The other Phase III study, KEYNOTE-185, is created to compare the combination of lenalidomide and low-dose dexamethasone plus Keytruda to lenalidomide and low-dose dexamethasone alone in patients with newly diagnosed and treatment-naïve multiple myeloma who are ineligible for autologous stem cell transplant (autoSCT).

Keytruda is a keystone drug for Merck. In May, the U.S. Food and Drug Administration expanded Keytruda's use by approving it for two new bladder cancer options. Keytruda is an antibody directed towards the programmed cell death protein 1 (PD-1) located on lymphocytes.

Keytruda is also approved for the treatment of patients with metastatic melanoma, metastatic non-small cell lung cancer, recurrent or metastatic head and neck cancer, refractory classical Hodgkin lymphoma, and urothelial carcinoma.

BMS' Opdivo, as well as Genentech (RHHBY)'s PD-1 inhibitor Tecentriq, have seen their share of troubles. In May, Merck KgaA (MKGAF.PK) and Pfizer saw approval for Bavencio.



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