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

Dimopoulos, M.A. (Meletios A.); Lonial, S. (Sagar); White, D.J. (Darrell J.); Moreau, P. (Philippe); Weisel, K. (Katja); San-Miguel, J.F. (Jesús F.); Shpilberg, O. (Ofer); Spicka, I. (Ivan); Walter-Croneck, A. (Adam); Magen, H. (Hila); Mateos, M.V. (María Victoria); Belch, A. (Andrew); Reece, D. (Donna); Beksac, M. (Meral); Spencer, A. (Andrew); Oakervee, H. (Heather); Orlowski, R.Z. (Robert Z.); Shpilberg, O. (Ofer); Taniwaki, M. (Masafumi); Röllig, C. (Christoph); Einsele, H. (Hermann); Matsumoto, M. (Morio); Wu, K.L. (Ka Lung); Anderson, K. (Kenneth C.); You, Y.M. (Ying-Ming); Ganetsky, A. (Alex); Singhal, A.K. (Anil K.); Richardson, P.G. (Paul G.)

Issue Date:

2020

ISSN:

2044-5385

Editorial note:

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Note:

This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons license, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons license and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/.

Citation:

Dimopoulos, M.A. (Meletios A.); Lonial, S. (Sagar); White, D.J. (Darrell J.); et al. "Elotuzumab, lenalidomide, and dexamethasone in RRMM: final overall survival results from the phase 3 randomized ELOQUENT-2 study". Blood Cancer Journal. 10 (91), 2020,

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.

URI:

https://hdl.handle.net/10171/66258

DOI:

10.1038/s41408-020-00357-4

Appears in Collections:

DA - CIMA - Hemato-oncología - Mieloma - Artículos de Revista

Files in This Item: