940TiP - Pembrolizumab in combination with lenalidomide and low-dose dexamethasone in newly diagnosed and treatment-naive multiple myeloma (MM): randomized,...

Date 08 October 2016
Event ESMO 2016 Congress
Session Poster Display
Topics Anti-Cancer Agents & Biologic Therapy
Plasma Cell Dyscrasias
Cancer Immunology and Immunotherapy
Presenter Antonio Palumbo
Citation Annals of Oncology (2016) 27 (6): 313-327. 10.1093/annonc/mdw375
Authors A. Palumbo1, M. Mateos2, J. San Miguel3, J. Shah4, S. Thompson5, P. Marinello5, S. Jagannath6
  • 1Medical Oncology, University of Torino, 8 - Torino/IT
  • 2Medical Oncology, University Hospital of Salamanca/IBSAL, 37007 - Salamanca/ES
  • 3Hematology, University of Navarra, Pamplona/ES
  • 4Division Of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston/US
  • 5Medical Oncology, Merck & Co., Inc., Kenilworth/US
  • 6Medical Oncology, Mount Sinai Medical Center, New York/US

Abstract

Background

PD-L1 is expressed on MM plasma cells and has been associated with higher MM cell proliferation. Thus, PD-L1 blockade with pembrolizumab may act synergistically with immunomodulatory drugs to enhance MM tumor suppression. In the phase 1 KEYNOTE-023 study, pembrolizumab + lenalidomide and low-dose dexamethasone showed an acceptable safety profile and promising preliminary efficacy in patients with relapsed/refractory MM, supporting further evaluation of this treatment combination. The randomized, open-label, phase 3 KEYNOTE-185 study (ClinicalTrials.gov, NCT02579863) was designed to compare the efficacy and safety of lenalidomide and low-dose dexamethasone (standard of care) with or without pembrolizumab in patients with newly diagnosed and treatment-naive MM.

Trial design

Key eligibility criteria include age ≥18 years, newly diagnosed, treatment-naive, active MM with measurable disease, and ineligibility for autologous stem cell transplantation. Patients will be randomized 1:1 to receive lenalidomide 25 mg daily on days 1-21 and low-dose dexamethasone 40 mg on days 1, 8, 15, and 22 of repeated 28-day cycles, with or without pembrolizumab 200 mg every 3 weeks. Patients will be stratified based on age (

Clinical trial identification

NCT02579863

Legal entity responsible for the study

Merck & Co., Inc.

Funding

Merck & Co., Inc.

Disclosure

J. San Miguel: Advisory board member for Celgene, Onyx, Novartis, Janssen, Amgen, Millennium, BMS, MSD. S. Thompson: Employee and Stockholder of Merck & Co Inc. P. Marinello: Employee of Merck & Co, Inc. All other authors have declared no conflicts of interest.