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FDA places clinical hold on three trials of Keytruda for myeloma

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The FDA placed a clinical hold on three studies designed to evaluate the use of pembrolizumab as part of combination treatment of multiple myeloma, according to the drug’s manufacturer.

The agency’s decision followed a data monitoring committee review in which additional deaths occurred among patients treated with pembrolizumab (Keytruda, Merck), an anti–PD-1 therapy, in two of those trials. That review led to a pause in new patient enrollment as of June 12.

The FDA determined that available data suggest the risks associated with pembrolizumab in combination with pomalidomide (Pomalyst, Celgene) or lenalidomide (Revlimid, Celgene) outweigh any potential benefit for patients with multiple myeloma.

The FDA placed a full clinical hold on:

• the phase 3 KEYNOTE-183 trial, designed evaluate treatment with pomalidomide and low-dose dexamethasone with or without pembrolizumab in patients with refractory or relapsed and refractory multiple myeloma; and
• the phase 3 KEYNOTE-185 study, designed to investigate treatment with lenalidomide and low-dose dexamethasone with or without pembrolizumab in patients with newly diagnosed and treatment-naive multiple myeloma.

The FDA placed a partial clinical hold on one cohort of KEYNOTE-023, a phase 1 multicohort trial designed to evaluate pembrolizumab in combination with backbone treatments for patients with myeloma. The hold relates to cohort 1, designed to evaluate pembrolizumab in combination with lenalidomide and dexamethasone in patients with myeloma who underwent prior treatment with an immunomodulatory agent, such as lenalidomide, pomalidomide or thalidomide (Thalomid, Celgene).

All patients treated in the KEYNOTE-183 and KEYNOTE-185 trials, and those in cohort 1 of the KEYNOTE-023 trial, will discontinue investigational treatment with pembrolizumab.

The FDA’s clinical hold does not apply to other studies with pembrolizumab.

“Patient safety is Merck’s primary concern, and we are grateful to the study investigators and patients involved in these studies for their commitment to this important research,” Roger M. Perlmutter, MD, PhD, president of Merck Research Laboratories, said in a company-issued press release. “Merck’s development program for Keytruda, spanning more than 30 different tumor types, has one priority: helping patients suffering from cancer.”