Pembrolizumab plus lenalidomide and dexamethasone for patients with treatment-naive multiple myeloma (KEYNOTE-185): a randomised, open-label, phase 3 trial

Publication date: Available online 18 July 2019Source: The Lancet HaematologyAuthor(s): Saad Zafar Usmani, Fredrik Schjesvold, Albert Oriol, Lionel Karlin, Michele Cavo, Robert M Rifkin, Habte Aragaw Yimer, Richard LeBlanc, Naoki Takezako, Robert Donald McCroskey, Andrew Boon Ming Lim, Kenshi Suzuki, Hiroshi Kosugi, George Grigoriadis, Irit Avivi, Thierry Facon, Sundar Jagannath, Sagar Lonial, Razi Uddin Ghori, Mohammed Z H FarooquiSummaryBackgroundLenalidomide and dexamethasone has been a standard of care in transplant-ineligible patients with newly diagnosed multiple myeloma. The addition of a third drug to the combination is likely to improve treatment efficacy. KEYNOTE-185 assessed the efficacy and safety of lenalidomide and dexamethasone with and without pembrolizumab in patients with previously untreated multiple myeloma. Here, we present the results of an unplanned interim analysis done to assess the benefit–risk of the combination at the request of the US Food and Drug Administration (FDA).MethodsKEYNOTE-185 was a randomised, open-label, phase 3 trial done at 95 medical centres across 15 countries (Australia, Canada, France, Germany, Ireland, Israel, Italy, Japan, New Zealand, Norway, Russia, South Africa, Spain, UK, and USA). Transplantation-ineligible patients aged 18 years and older with newly diagnosed multiple myeloma, Eastern Cooperative Oncology Group performance status of 0 or 1, and who were treatment naive were enrolled, and randomly assigned 1:1 to receiv...
Source: The Lancet Haematology - Category: Hematology Source Type: research