Elotuzumab, lenalidomide, and dexamethasone in RRMM: final overall survival results from the phase 3 randomized ELOQUENT-2 study

Dimopoulos MA, Lonial S, White D, Moreau P, Weisel K, San-Miguel J, Shpilberg O, Grosicki S, Spicka I, Walter-Croneck A, Magen H, Mateos MV, Belch A, Reece D, Beksac M, Spencer A, Oakervee H, Orlowski RZ, Taniwaki M, Roellig C, Einsele H, Matsumoto M, Wu KL, Anderson KC, Jou YM, Ganetsky A, Singhal AK, Richardson PG (2020)

Publication Type: Journal article

Publication year: 2020

Journal

Book Volume: 10

Article Number: 91

Journal Issue: 9

DOI: 10.1038/s41408-020-00357-4

Abstract

Prolonging overall survival (OS) remains an unmet need in relapsed or refractory multiple myeloma (RRMM). In ELOQUENT-2 (NCT01239797), elotuzumab plus lenalidomide/dexamethasone (ERd) significantly improved progression-free survival (PFS) versus lenalidomide/dexamethasone (Rd) in patients with RRMM and 1–3 prior lines of therapy (LoTs). We report results from the pre-planned final OS analysis after a minimum follow-up of 70.6 months, the longest reported for an antibody-based triplet in RRMM. Overall, 646 patients with RRMM and 1–3 prior LoTs were randomized 1:1 to ERd or Rd. PFS and overall response rate were co-primary endpoints. OS was a key secondary endpoint, with the final analysis planned after 427 deaths. ERd demonstrated a statistically significant 8.7-month improvement in OS versus Rd (median, 48.3 vs 39.6 months; hazard ratio, 0.82 [95.4% Cl, 0.68–1.00]; P = 0.0408 [less than allotted α of 0.046]), which was consistently observed across key predefined subgroups. No additional safety signals with ERd at extended follow-up were reported. ERd is the first antibody-based triplet regimen shown to significantly prolong OS in patients with RRMM and 1–3 prior LoTs. The magnitude of OS benefit was greatest among patients with adverse prognostic factors, including older age, ISS stage III, IMWG high-risk disease, and 2–3 prior LoTs.

Involved external institutions

National and Kapodistrian University of Athens Greece (GR) Emory University United States (USA) (US) Queen Elizabeth II Health Sciences Centre Canada (CA) Universitätsklinikum Heidelberg Germany (DE) Universitätsklinikum Hamburg-Eppendorf (UKE) Germany (DE) Clínica Universidad de Navarra Spain (ES) Medical University of Silesia in Katowice / Śląski Uniwersytet Medyczny w Katowicach (SUM) Poland (PL) Univerzita Karlova v Praze / Charles University in Prague Czech Republic (CZ) Medical University of Lublin / Uniwersytet Medyczny w Lublinie Poland (PL) Tel Aviv University Israel (IL) University of Salamanca / Universidad de Salamanca Spain (ES) University of Alberta Hospital Canada (CA) Princess Margaret Cancer Centre / Princess Margaret Hospital Canada (CA) Ankara University / Ankara Üniversitesi Turkey (TR) Monash University Australia (AU) Barts Health NHS Trust United Kingdom (GB) University of Texas MD Anderson Cancer Center United States (USA) (US) Kyoto Prefectural University of Medicine / 京都府立医科大学 Japan (JP) Universitätsklinikum Carl Gustav Carus Dresden Germany (DE) Universitätsklinikum Würzburg Germany (DE) Shibukawa Medical Center / 渋川医療センター Japan (JP) Hospital Network Antwerp / Ziekenhuis Netwerk Antwerpen (ZNA) Belgium (BE) Dana–Farber Cancer Institute United States (USA) (US) Bristol-Myers Squibb GmbH & Co. KGaA Germany (DE) AbbVie Inc. United States (USA) (US)

How to cite

APA:

Dimopoulos, M.A., Lonial, S., White, D., Moreau, P., Weisel, K., San-Miguel, J.,... Richardson, P.G. (2020). Elotuzumab, lenalidomide, and dexamethasone in RRMM: final overall survival results from the phase 3 randomized ELOQUENT-2 study. Blood Cancer Journal, 10(9). https://dx.doi.org/10.1038/s41408-020-00357-4

MLA:

Dimopoulos, Meletios A., et al. "Elotuzumab, lenalidomide, and dexamethasone in RRMM: final overall survival results from the phase 3 randomized ELOQUENT-2 study." Blood Cancer Journal 10.9 (2020).

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