FDA places hold on three clinical trials involving Keytruda (pembrolizumab) plus pomalidomide or lenalidomide for multiple myeloma- Merck Inc.

Merck has announced that the FDA has placed a clinical hold on KEYNOTE-183, KEYNOTE-185 and KEYNOTE-023, three combination studies of Keytruda (pembrolizumab), the company’s anti-PD-1 therapy, in the blood cancer 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 and which led to the pause in new patient enrolment, as announced in June 2017. The FDA has determined that the data available at the present time indicate that the risks of pembrolizumab plus pomalidomide or lenalidomide outweigh any potential benefit for patients with multiple myeloma. All patients enrolled in KEYNOTE-183 and KEYNOTE-185 and 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 with pembrolizumab.

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-183).” • KEYNOTE-185: “A Phase III study of Lenalidomide and low-dose Dexamethasone with or without Pembrolizumab (MK3475) in newly diagnosed and treatment naïve Multiple Myeloma (KEYNOTE-185).” The following study has been placed on partial clinical hold: • KEYNOTE-023 Cohort 1: “A Phase I Multi-Cohort Trial of Pembrolizumab (MK-3475) in Combination with Backbone Treatments for Subjects with Multiple Myeloma (KEYNOTE 023).” Cohort 1 of KEYNOTE-023 evaluated Keytruda (pembrolizumab) in combination with lenalidomide and dexamethasone in patients who received prior anti-multiple myeloma treatment with an immunomodulatory (IMiD) treatment (lenalidomide, pomalidomide or thalidomide).