Scientific publications

Elotuzumab plus lenalidomide/dexamethasone for relapsed or refractory multiple myeloma: ELOQUENT-2 follow-up and post-hoc analyses on progression-free survival and tumour growth

Dimopoulos MA (1), Lonial S (2), White D (3), Moreau P (4), Palumbo A (5), San-Miguel J (6), Shpilberg O (7), Anderson K (8), Grosicki S (9), Spicka I (10), Walter-Croneck A (11), Magen H (12), Mateos MV (13), Belch A (14), Reece D (15), Beksac M (16), Bleickardt E (17), Poulart V (18), Sheng J (19), Sy O (20), Katz J (21), Singhal A (22), Richardson P (23). (1) Department of Clinical Therapeutics, National and Kapodistrian University of Athens School of Medicine, Athens, Greece.
(2) Department of Hematology and Medical Oncology, Winship Cancer Institute, Emory University School of Medicine, Atlanta, GA, USA.
(3) Division of Hematology, Queen Elizabeth II Health Sciences Centre and Dalhousie University, Halifax, NS, Canada.
(4) Department of Haematology, University Hospital, Nantes, France.
(5) Myeloma Unit, Division of Haematology, University of Torino, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Torino, Italy.
(6) Clinica Universidad de Navarra, Investigación Médica Aplicada, IDISNA, CIBERONC, Pamplona, Spain.
(7) Institute of Haematology, Assuta Medical Centers, Tel Aviv, Israel.
(8) Division of Hematologic Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.
(9) Department of Cancer Prevention, Medical University of Silesia, Katowice, Poland.
(10) 1st Department of Medicine - Department of Haematology, First Faculty of Medicine, Charles University and General Teaching Hospital in Prague, Prague, Czech Republic.
(11) Department of Haemato-oncology and Bone Marrow Transplantation, Medical University of Lublin, Lublin, Poland.
(12) Davidoff Cancer Center, Rabin Medical Center, Petah Tikva, Israel.
(13) Haematology Department, University Hospital of Salamanca-Instituto de Investigación Biomédica de Salamanca (IBSAL), Salamanca, Spain.
(14) Department of Oncology, Cross Cancer Institute and University of Alberta, Edmonton, AB, Canada.
(15) Department of Medical Oncology and Haematology, Princess Margaret Cancer Centre, Toronto, ON, Canada.
(16) Department of Haematology, Ankara University, Ankara, Turkey.
(17) Oncology Clinical Development, Bristol-Myers Squibb, Lawrenceville, NJ, USA.
(18) Global Biostatistics, Bristol-Myers Squibb, Lawrenceville, NJ, USA.
(19) Clinical Pharmacology & Pharmacometrics, Bristol-Myers Squibb, Lawrenceville, NJ, USA.
(20) Global Biometric Sciences, Bristol-Myers Squibb, Lawrenceville, NJ, USA.
(21) Global Clinical Research (Research and Development Oncology), Bristol-Myers Squibb, Lawrenceville, NJ, USA.
(22) AbbVie Biotherapeutics Inc. (ABR), Redwood City, CA, USA.
(23) Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.

Magazine: British Journal of Haematology

Date: Jul 5, 2017

Hematología y Hemoterapia [SP]

ABSTRACT

The randomized phase III ELOQUENT-2 study (NCT01239797) evaluated the efficacy and safety of elotuzumab + lenalidomide/dexamethasone (ELd) versus lenalidomide/dexamethasone (Ld) in relapsed/refractory multiple myeloma.

ELd reduced the risk of disease progression/death by 30% versus Ld (hazard ratio [HR] 0·70). Median time from diagnosis was 3·5 years. We present extended 3-year follow-up data. Endpoints included progression-free survival (PFS), overall response rate (ORR) and interim overall survival (OS).

Exploratory post-hoc analyses included impact of time from diagnosis and prior lines of therapy on PFS, and serum M-protein dynamic modelling. ORR was 79% (ELd) and 66% (Ld) (P = 0·0002). ELd reduced the risk of disease progression/death by 27% versus Ld (HR 0·73; P = 0·0014). Interim OS demonstrated a trend in favour of ELd (P = 0·0257); 1-, 2- and 3-year rates with ELd versus Ld were: 91% versus 83%, 73% versus 69% and 60% versus 53%.

In patients with ≥ median time from diagnosis and one prior therapy, ELd resulted in a 53% reduction in the risk of progression/death versus Ld (HR 0·47). Serum M-protein dynamic modelling showed slower tumour regrowth with ELd.

Adverse events were comparable between arms. ELd provided a durable and clinically relevant improvement in efficacy, with minimal incremental toxicity.

CITATION  Br J Haematol. 2017 Jul 5. doi: 10.1111/bjh.14787

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