Rare Disease Report

Multiple Myeloma Studies On Hold to Assess High Death Count

JUNE 12, 2017
James Radke
An increased number of deaths observed in 2 Phase 3 cancer studies involving Keytruda (pembrolizumab) in multiple myeloma patients has led Merck to pause recruitment.
Multiple myeloma is a cancer that forms in the plasma cells that causes cancer cells to accumulate in bone marrow. Symptoms include bone pain, nausea, constipation, loss of appetite, mental issues and excessive thirst. It is a rare and aggressive disease that accounts for approximately 1% of all cancers.
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. The 2 clinical trials are the KEYNOTE-183 and KEYNOTE-185 studies testing pembrolizumab in combination with other therapies in patients with multiple myeloma.
The KEYNOTE-183 study compares pembrolizumab plus pomalidomide and low-dose dexamethasone to pomalidomide and low-dose dexamethasone alone in patients with refractory or relapsed and refractory multiple myeloma (rrMM) who have undergone at least 2 lines of prior treatment.
KEYNOTE-185, a Phase 3 study, compares pembrolizumab plus lenalidomide and low-dose dexamethasone 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.
At present, the number of deaths that raised concerns with the Data Monitoring Committee has not been shared but all other clinical trials involving pembrolizumab are continuing.
Keytruda is an antibody directed towards the programmed cell death protein 1 (PD-1) located on lymphocytes.
Keytruda is approved for a variety of common and rare cancers, including lung cancer, head and neck cancer, metastatic melanoma, classical Hodgkin lymphoma, urothelial carcinoma, and microsatellite instability-high (MSI-H) cancer.

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