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

Autores: Dimopoulos, M. A. (Autor de correspondencia); Lonial, S.; White, D.; Moreau, P.; Weisel, K. ; San Miguel Izquierdo, Jesús; Shpilberg, O. ; Grosicki, S.; Spicka, I.; Walter-Croneck, A.; Magen, H.; Mateos, M. V.; Belch, A.; Reece, D.; Beksac, M.; Spencer, A.; Oakervee, H.; Orlowski, R. Z.; Taniwaki, M.; Rollig, C.; Einsele, H.; Matsumoto, M. ; Wu, K. L.; Anderson, K. C.; Jou, Y. M. ; Ganetsky, A.; Singhal, A. K.; Richardson, P. G.
Título de la revista: BLOOD CANCER JOURNAL
ISSN: 2044-5385
Volumen: 10
Número: 9
Páginas: 91
Fecha de publicación: 2020
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 alpha 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.