Elotuzumab plus lenalidomide and dexamethasone in relapsed/refractory multiple myeloma: Extended 4-year follow-up and analysis of relative progression-free survival from the randomized ELOQUENT-2 trial.

Autor: Dimopoulos MA; National and Kapodistrian University of Athens School of Medicine, Athens, Greece., Lonial S; Winship Cancer Institute, Emory University School of Medicine, Atlanta, Georgia., Betts KA; Analysis Group, Inc, Boston, Massachusetts., Chen C; Bristol-Myers Squibb, Princeton, New Jersey., Zichlin ML; Analysis Group, Inc, Boston, Massachusetts., Brun A; Bristol-Myers Squibb, Princeton, New Jersey., Signorovitch JE; Analysis Group, Inc, Boston, Massachusetts., Makenbaeva D; Bristol-Myers Squibb, Princeton, New Jersey., Mekan S; Bristol-Myers Squibb, Princeton, New Jersey., Sy O; Bristol-Myers Squibb, Princeton, New Jersey., Weisel K; University of Tübingen, Tübingen, Germany., Richardson PG; Dana-Farber Cancer Institute, Boston, Massachusetts.
Jazyk: angličtina
Zdroj: Cancer [Cancer] 2018 Oct 15; Vol. 124 (20), pp. 4032-4043. Date of Electronic Publication: 2018 Sep 11.
DOI: 10.1002/cncr.31680
Abstrakt: Background: The randomized phase 3 ELOQUENT-2 study (NCT01239797) evaluated the efficacy and safety of elotuzumab plus lenalidomide and dexamethasone (ELd) versus lenalidomide and dexamethasone (Ld) in relapsed/refractory multiple myeloma (RRMM), and to date, has the longest follow-up of any monoclonal antibody in patients with RRMM.
Methods: In this extended 4-year follow-up of the ELOQUENT-2 trial, the coprimary endpoints of progression-free survival (PFS) and overall response rate as well as the secondary endpoint of overall survival were assessed. In the absence of head-to-head trials comparing Ld-based triplet regimens to guide treatment selection, 4 randomized controlled trials-ELOQUENT-2, ASPIRE, TOURMALINE-MM1, and POLLUX-were indirectly compared to provide insight into the relative efficacy of these regimens in RRMM.
Results: Data at 4 years were consistent with 2- and 3-year follow-up data: ELd reduced the risk of disease progression/death by 29% versus Ld (hazard ratio, 0.71) while maintaining safety. The greatest PFS benefit among the assessed subgroups was observed in patients at the median time or further from diagnosis (≥3.5 years) with 1 prior line of therapy, who had a 44% reduction in the risk of progression/death, and in patients in the high-risk category, who had a 36% reduction in favor of ELd. This regimen also showed a relative PFS benefit that was maintained beyond 50 months.
Conclusions: The sustained PFS benefit and long-term safety of ELd at 4 years, similar to those observed at 2 and 3 years, support ELd as a valuable therapeutic option for the long-term treatment of patients with RRMM.
(© 2018 The Authors. Cancer published by Wiley Periodicals, Inc. on behalf of American Cancer Society.)
Databáze: MEDLINE
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