FDA Places Hold on Multiple Keytruda Clinical Trials

Prembrolizumab (Keytruda) combination observed to have a high mortality rate.

Merck recently announced that the FDA has placed a clinical hold on 3 clinical trials of pembrolizumab (Keytruda) in patients with multiple myeloma.

The FDA placed a clinical hold on KEYNOTE-183, KEYNOTE-185, and KEYNOTE-023 due to a higher number of deaths in the treatment arms for KEYNOTE-183 and KEYNOTE-185, according to a press release. This finding also led to a pause in patient enrollment in June 2017.

At this time, the FDA has decided that the data indicates the risk of pembrolizumab plus pomalidomide or lenalidomide outweigh the benefits for patients with multiple myeloma, according to the release.

All patients included in the KEYNOTE-183 and KEYNOTE-185 clinical trials and patients treated with pembrolizumab/lenalidomide/dexamethasone will discontinue treatment.

However, Merck reported that the clinical hold does not affect other clinical trials of pembrolizumab.

The FDA has placed a full clinical hold on KEYNOTE-183, which is a phase 3 study of pomalidomide, low-dose dexamethasone, plus pembrolizumab or placebo in patients with refractory or relapsed and refractory multiple myeloma, according to the release.

A full clinical hold has also been placed on KEYNOTE-185, which is a phase 3 study of the combination therapy in treatment-naïve patients with multiple myeloma.

The FDA only placed a partial clinical hold on cohort 1 from KEYNOTE-023, which is a phase 1 study of pembrolizumab plus backbone treatments for patients with multiple myeloma, according to the release. Cohort 1 examined treatment with pembrolizumab plus lenalidomide and dexamethasone in patients who received prior treatment with lenalidomide, pomalidomide, or thalidomide.

Currently, pembrolizumab is indicated to treat patients with melanoma, lung cancer, head and neck cancer, classical Hodgkin Lymphoma, urothelial carcinoma, and microsatellite instability-high cancer.

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