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 Cytotoxic agents
Plasma Cell Dyscrasias
Immunotherapy
Therapy
Biological therapy
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.