Page 164 - 2018_12-Haematologica-web

Ferrata Storti Foundation
Plasma Cell Disorders
Daratumumab plus lenalidomide and dexamethasone versus lenalidomide and dexamethasone in relapsed or refractory multiple myeloma: updated analysis of POLLUX
Haematologica 2018 Volume 103(12):2088-2096
Meletios A. Dimopoulos,1 Jesus San-Miguel,2 Andrew Belch,3 Darrell White,4 Lotfi Benboubker,5 Gordon Cook,6 Merav Leiba,7 James Morton,8 P. Joy Ho,9 Kihyun Kim,10 Naoki Takezako,11 Philippe Moreau,12 Jonathan L. Kaufman,13
14 15 16 17 Heather J. Sutherland, Marc Lalancette, Hila Magen, Shinsuke Iida,
Jin Seok Kim,18 H. Miles Prince,19 Tara Cochrane,20 Albert Oriol,21
Nizar J. Bahlis,22 Ajai Chari,23 Lisa O’Rourke,24 Kaida Wu,24
Jordan M. Schecter,25 Tineke Casneuf,26 Christopher Chiu,24 David Soong,24 A. Kate Sasser,27 Nushmia Z. Khokhar,24 Hervé Avet-Loiseau28 and Saad Z. Usmani29
1The National and Kapodistrian University of Athens, Greece; 2Clínica Universidad de Navarra-CIMA, IDISNA, CIBERONC, Pamplona, Spain; 3Department of Oncology, University of Alberta Cross Cancer Institute, Edmonton, Canada; 4QEII Health Sciences Center and Dalhousie University, Halifax, Nova Scotia, Canada; 5Service d’Hématologie et Thérapie Cellulaire, Hôpital Bretonneau, Centre Hospitalier Régional Universitaire (CHRU), Tours, France; 6St James’s Institute of Oncology, Leeds Teaching Hospitals NHS Trust and University of Leeds, UK; 7Sheba Medical Center, Tel Hashomer, Ramat Gan, Israel; 8Icon Cancer Care, South Brisbane, QLD, Australia; 9Institute of Haematology, Royal Prince Alfred Hospital, Camperdown, NSW, Australia; 10Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea; 11Department of Hematology, National Hospital Organization Disaster Medical Center of Japan, Tachikawa, Japan; 12Department of Hematology, University Hospital Hôtel-Dieu, Nantes, France; 13Winship Cancer Institute, Emory University, Atlanta, GA, USA; 14Leukemia/Bone Marrow Transplant Program, University of British Columbia, Vancouver, Canada; 15CHU de Québec Research Center, Faculty of Medicine, Laval University, Canada; 16Institute of Hematology, Davidoff Cancer Center, Beilinson Hospital, Rabin Medical Center, Petah-Tikva, Israel; 17Department of Hematology and Oncology, Nagoya City University Graduate School of Medical Sciences, Japan;
18Yonsei University College of Medicine, Severance Hospital, Seoul, South Korea; 19Cabrini Hospital, Epworth HealthCare and Sir Peter MacCallum Department of Oncology, University of Melbourne, VIC, Australia; 20Gold Coast University Hospital, Southport, QLD, Australia; 21Institut Català d’Oncologia i Institut Josep Carreras, Hospital Germans Trias I Pujol, Barcelona, Spain; 22University of Calgary, Arnie Charbonneau Cancer Institute, Alberta, Canada; 23Icahn School of Medicine at Mount Sinai, New York, NY, USA; 24Janssen Research & Development, LLC, Spring House, PA, USA; 25Janssen Research & Development, LLC, Raritan, NJ, USA; 26Janssen Research & Development, Beerse, Belgium; 27Genmab US, Inc, Princeton, NJ, USA; 28Unite de Genomique du Myelome, IUC-Oncopole, Toulouse, France and 29Levine Cancer Institute/Atrium Health, Charlotte, NC, USA
ABSTRACT
In the POLLUX study, daratumumab plus lenalidomide/dexametha- sone significantly reduced risk of progression/death versus lenalido- mide/dexamethasone alone in relapsed/refractory multiple myeloma. We provide one additional year of follow up and include the effect on minimal residual disease and in clinically relevant subgroups. After 25.4 months of follow up, daratumumab plus lenalidomide/dexamethasone prolonged progression-free survival versus lenalidomide/dexamethasone alone (median not reached vs. 17.5 months; hazard ratio, 0.41; 95% con- fidence interval, 0.31-0.53; P<0.0001). The overall response rate was 92.9% versus 76.4%, and 51.2% versus 21.0% achieved a complete response or better, respectively (both P<0.0001). At the 10–5 sensitivity threshold, 26.2% versus 6.4% were minimal residual disease–negative, respectively (P<0.0001). Post hoc analyses of clinically relevant patient subgroups demonstrated that progression-free survival was significantly prolonged for daratumumab plus lenalidomide/dexamethasone versus
Correspondence:
mdimop@med.uoa.gr
Received: March 27, 2018. Accepted: August 21, 2018. Pre-published: September 20, 2018.
doi:10.3324/haematol.2018.194282
Check the online version for the most updated information on this article, online supplements, and information on authorship & disclosures: www.haematologica.org/content/103/12/2088
©2018 Ferrata Storti Foundation
Material published in Haematologica is covered by copyright. All rights are reserved to the Ferrata Storti Foundation. Use of published material is allowed under the following terms and conditions: https://creativecommons.org/licenses/by-nc/4.0/legalcode. Copies of published material are allowed for personal or inter- nal use. Sharing published material for non-commercial pur- poses is subject to the following conditions: https://creativecommons.org/licenses/by-nc/4.0/legalcode, sect. 3. Reproducing and sharing published material for com- mercial purposes is not allowed without permission in writing from the publisher.
2088
haematologica | 2018; 103(12)
ARTICLE