The US Food and Drug Administration (FDA) has put a clinical hold on 2 clinical studies, KEYNOTE-183 (ClinicalTrials.gov Identifier: NCT02576977), KEYNOTE-185 (ClinicalTrials.gov Identifier: NCT02579863), and a partial clinical hold on KEYNOTE-023 (ClinicalTrials.gov Identifier: NCT02036502).1
The KEYNOTE trials were planned to evaluate the effectiveness of pembrolizumab, a PD-1 inhibitor, for the treatment of multiple myeloma.
KEYNOTE-183 was evaluating the effects of pomalidomide and dexamethasone with or without pembrolizumab in refractory or relapsed and refractory multiple myeloma. KEYNOTE-185 was evaluating lenalidomide and dexamethasone with or without pembrolizumab in newly diagnosed and treatment naïve multiple myeloma.
The decision to halt the studies was based on a review of data by the Data Monitoring Committee, which showed that more deaths occurred in the KEYNOTE-183 and KEYNOTE-185 trials for patients in the pembrolizumab arms.
The FDA determined that the available evidence shows the risks presented by pembrolizumab plus pomalidomide or lenalidomide are greater than any potential benefit for patients with multiple myeloma.
Enrolled patients receiving investigational therapy will discontinue pembrolizumab in all halted trials.
No other trials of pembrolizumab are affected by this decision.
- Merck provides further update on three multiple myeloma studies evaluating Keytruda (pembrolizumab) in combination with pomalidomide or lenalidomide [news release]. Kenilworth, NJ: Business Wire; July 6, 2017. http://www.businesswire.com/news/home/20170705006004/en. Accessed July 6 2017.