Scientific publications

Daratumumab plus lenalidomide and dexamethasone versus lenalidomide and dexamethasone in relapsed or refractory multiple myeloma: updated analysis of POLLUX

Dimopoulos MA (1), San-Miguel J (2), Belch A (3), White D (4), Benboubker L (5), Cook G (6), Leiba M (7), Morton J (8), Ho PJ (9), Kim K (10), Takezako N (11), Moreau P (12), Kaufman JL (13), Sutherland HJ (14), Lalancette M (15), Magen H (16), Iida S (17), Kim JS (18), Prince HM (19), Cochrane T (20), Oriol A (21), Bahlis NJ (22), Chari A (23), O' Rourke L (24), Wu K (24), Schecter JM (25), Casneuf T (26), Chiu C (24), Soong D 24, Sasser AK (27), Khokhar NZ (24), Avet-Loiseau H (28), Usmani SZ (29).

(1) The National and Kapodistrian University of Athens, Athens, Greece
(2) Clínica Universidad de Navarra-CIMA, IDISNA, CIBERONC, Pamplona, Spain.
(3) Department of Oncology, University of Alberta Cross Cancer Institute, Edmonton, Alberta, Canada.
(4) QEII Health Sciences Center and Dalhousie University, Halifax, Nova Scotia, Canada.
(5) Hôpital Bretonneau, Centre Hospitalier Régional Universitaire (CHRU), Tours, France.
(6) St James Institute of Oncology, Leeds Teaching Hospitals NHS Trust and University of Leeds.
(7) Sheba Medical Center, Tel Hasher, Ramat Gan, Israel.
(8) Icon Cancer Care, South Brisbane, QLD, Australia.
(9) Institute of Haematology, Royal Prince Alfred Hospital, Camperdown, NSW, Australia.
(10) Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul.
(11) Dept of Hematology, National Hospital Organization Disaster Medical Center of Japan, Tachikawa.
(12) Hematology, University Hospital Hôtel-Dieu, Nantes, France.
(13) Winship Cancer Institute, Emory University, Atlanta, GA, USA.
(14) Leukemia/Bone Marrow Transplant Program, University of British Columbia, Vancouver, British Columbia.
(15) CHU de Québec Research Center, Faculty of Medicine, Laval University, Québec, Canada.
(16) Institute of Hematol, Davidoff Cancer Center, Beilinson Hospital, Rabin Medical Center, Petah-Tikva.
(17) Dept of Hematology/Oncology, Nagoya City University Graduate School of Medical Sciences, Nagoya.
(18) Yonsei University College of Medicine, Severance Hospital, Seoul, South Korea.
(19) Epworth HealthCare and Sir Peter MacCallum Department of Oncology, University of Melbourne.
(20) Gold Coast University Hospital, Southport, QLD, Australia.
(21) Institut Catalá Oncologia,Institut Josep Carreras,Hospital Germans Trias I Pujol, Barcelona.
(22) University of Calgary, Arnie Charbonneau Cancer Institute, Calgary, AB, Canada.
(23) Icahn School of Medicine at Mount Sinai, New York, NY, USA.
(24) Janssen Research & Development, LLC, Spring House, PA, USA.
(25) Janssen Research & Development, LLC, Raritan, NJ, USA.
(26) Janssen Research & Development, Beerse, Belgium.
(27) Genmab US, Inc, Princeton, NJ, USA.
(28) Unite de Genomique du Myelome, IUC-Oncopole, Toulouse, France.
(29) Levine Cancer Institute/Atrium Health, Charlotte, NC, USA.

Magazine: Haematologica

Date: Sep 20, 2018

Hematología y Hemoterapia [SP]

ABSTRACT

In the POLLUX study, daratumumab plus lenalidomide/dexamethasone significantly reduced risk of progression/death versus lenalidomide/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% confidence 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 10e5 sensitivity threshold, 26.2% versus 6.4% were minimal residual disease-negative, respectively (P <0.0001).

Post hoc analyses of clinical relevant patient subgroups demonstrated that progression-free survival was significantly prolonged for daratumumab plus lenalidomide/dexamethasone versus lenalidomide/dexamethasone regardless of number of prior lines of therapy.

Patients previously treated with lenalidomide or thalidomide and those refractory to bortezomib received similar benefits (all P <0.01). Treatment benefit with daratumumab plus lenalidomide/dexamethasone was maintained in high-risk patients (median progression-free survival 22.6 vs 10.2 months; hazard ratio, 0.53; 95% confidence interval, 0.25-1.13; P = 0.0921) and patients with treatment-free intervals of >12 and ≤12 months, >6 and ≤6 months.

No new safety signals were observed. In relapsed/refractory multiple myeloma patients, daratumumab plus lenalidomide/dexamethasone continued to improve progression-free survival and deepen responses versus lenalidomide/dexamethasone.

CITATION Haematologica. 2018 Sep 20. pii: haematol.2018.194282. doi: 10.3324/haematol.2018.194282

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