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FDA Puts Clinical Hold on Merck's Multiple Myeloma Trials Following Increased Deaths

JULY 05, 2017
James Radke
Merck announced that the U.S. Food and Drug Administration (FDA) has placed a complete clinical hold on 2 clinical trials testing Keytruda (pembrolizumab) in combination with pomalidomide or lenalidomide to treat multiple myeloma. The FDA is also placing a partial hold on a 3rd multiple myeloma trial in which one treatment group in the study was receiving pembrolizumab plus lenalidomide
 
The decision was taken after a review of the data found more deaths in multiple myeloma patients receiving pembrolizumab in combination with pomalidomide or lenalidomide than in the control groups in 2 clinical trials.
 
This clinical hold does not apply to other clinical trials involving Keytruda which is being tested in a number of cancer populations. This hold only applies to multiple myeloma patients receiving pembrolizumab in combination with pomalidomide or lenalidomide.
 
The following studies have been placed on full clinical hold:
  • KEYNOTE-183: “A Phase III study of pomalidomide and low-dose Dexamethasone with or without pembrolizumab in refractory or relapsed and refractory multiple myeloma.”
  • KEYNOTE-185: “A Phase III study of lenalidomide and low-dose Dexamethasone with or without pembrolizumab in newly diagnosed and treatment naïve multiple myeloma.”
 
The following study has been placed on partial clinical hold:
  • KEYNOTE-023 Cohort 1: “A Phase I multi-cohort trial of pembrolizumab p in combination with backbone treatments for subjects with multiple myeloma.”
    • In cohort 1 of this study, patients were receiving pembrolizumab in combination with lenalidomide and dexamethasone. That has been discontinued. A second cohort of patients receiving pembrolizumab in combination with carfilzomib and dexamethasone will continue.
 
Per a news release: “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 Dr. Roger M. Perlmutter, president, Merck Research Laboratories. “Merck’s development program for Kyetruda, spanning more than 30 different tumor types, has one priority: helping patients suffering from cancer.”
 
Keytruda (pembrolizumab) is approved for a variety of rare and common cancers, including:
  • Malignant Melanoma (rare)
  • Lung Cancer
  • Head and Neck Cancer
  • Classical Hodgkin Lymphoma (rare)
  • Urothelial Carcinoma
  • Microsatellite Instability-High (MSI-H) Cancer
 
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