FDA Flags 3 Keytruda Combination Trials in Multiple Myeloma


Two KEYNOTE trials were placed on full clinical hold and 1 partial clinical hold.

Last week, the FDA placed a clinical hold on 3 trials evaluating pembrolizumab (Keytruda) combination treatment in patients with multiple myeloma, citing patient deaths.

The decision follows a review by the Data Monitoring Committee, in which more deaths were observed in the pembrolizumab arm of KEYNOTE-183 and KEYNOTE-185, according to a press release.

Pembrolizumab is a humanized monoclonal antibody designed to inhibit the interaction between PD-1 and its ligands PD-L1 and PD-L2, which activates T cells.

The FDA concluded that the available data indicates that the risk of pembrolizumab plus pomalidomide or lenalidomide outweigh any potential benefits. All participants enrolled in the KEYNOTE-183 and KEYNOTE-185 trials and patients in the combination pembrolizumab/lenalidomide/dexamethasone cohort in KEYNOTE-023 will discontinue treatment.

KEYNOTE-183 is a phase 3 trial evaluating pomalidomide and low-dose dexamethasone with or without pembrolizumab in patients with refractory or relapsed and refractory multiple myeloma. The phase 3 KEYNOTE-184 trial examined lenalidomide and low-dose dexamethasone with or without pembrolizumab in newly diagnosed and treatment naïve patients with multiple myeloma.

Both KEYNOTE-183 and KEYNOTE-185 have been placed on a full clinical hold, according to the release.

KEYNOTE-023 is a phase 1 multi-cohort trial of pembrolizumab in combination with backbone treatments for patients with multiple myeloma. Cohort 1 of KEYNOTE-023 has been placed on partial clinical hold. It evaluated pembrolizumab in combination with lenalidomide and dexamethasone in patients who received prior anti-cancer treatment with an immunomodulatory treatment—–lenalidomide, pomalidomide, or thalidomide.

“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,” Dr Roger M. Perlmutter, president, Merck Research Laboratories, said in a release. “Merck’s development program for Keytruda, spanning more than 30 different tumor types has one priority: helping patients suffering from cancer.”

Pembrolizumab is approved to treat melanoma, lung cancer, head and neck cancer, classical Hodgkin lymphoma, urothelial carcinoma, and unresectable/metastatic microsatellite instability-high cancer.

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