FDA Places Clinical Hold on Three Studies Evaluating Pembrolizumab in Multiple Myeloma

On July 5, Merck announced that the U.S. Food and Drug Administration (FDA) has placed a clinical hold on KEYNOTE-183, KEYNOTE-185, and KEYNOTE-023, three combination studies of pembrolizumab (Keytruda), an anti–programmed cell death protein 1 (PD-1) therapy, in multiple myeloma. This decision follows a review of data by the data monitoring committee in which more deaths were observed in the pembrolizumab arms of KEYNOTE-183 and KEYNOTE-185, which led to the pause in new patient enrollment, as announced on June 12, 2017.

The FDA has determined that the data available at the present time indicate that the risks of pembrolizumab plus pomalidomide (Pomalyst) or lenalidomide (Revlimid) outweigh any potential benefit for patients with multiple myeloma. All patients enrolled in KEYNOTE-183 and KEYNOTE-185 as well as those in the pembrolizumab/lenalidomide/dexamethasone cohort in KEYNOTE-023 will discontinue investigational treatment with pembrolizumab. This clinical hold does not apply to other studies of pembrolizumab.

In summary, 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 (MK3475) in Refractory or Relapsed and Refractory Multiple Myeloma
  • KEYNOTE-185: A Phase III Study of Lenalidomide and Low-Dose Dexamethasone With or Without Pembrolizumab (MK3475) in Newly Diagnosed and Treatment-Naive Multiple Myeloma

The following study has been placed on partial clinical hold:

  • KEYNOTE-023 Cohort 1: A Phase I Multicohort Trial of Pembrolizumab (MK-3475) in Combination With Backbone Treatments for Subjects With Multiple Myeloma. Cohort 1 of KEYNOTE-023 evaluated pembrolizumab in combination with lenalidomide and dexamethasone in patients who received prior anti–multiple myeloma treatment with an immunomodulatory treatment (lenalidomide, pomalidomide, or thalidomide [Thalomid]).

“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, PhD, President, Merck Research Laboratories. 

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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