TY - JOUR
T1 - Elotuzumab, lenalidomide, and dexamethasone in RRMM
T2 - final overall survival results from the phase 3 randomized ELOQUENT-2 study
AU - Dimopoulos, Meletios A.
AU - Lonial, Sagar
AU - White, Darrell
AU - Moreau, Philippe
AU - Weisel, Katja
AU - San-Miguel, Jesus
AU - Shpilberg, Ofer
AU - Grosicki, Sebastian
AU - Špička, Ivan
AU - Walter-Croneck, Adam
AU - Magen, Hila
AU - Mateos, Maria Victoria
AU - Belch, Andrew
AU - Reece, Donna
AU - Beksac, Meral
AU - Spencer, Andrew
AU - Oakervee, Heather
AU - Orlowski, Robert Z.
AU - Taniwaki, Masafumi
AU - Röllig, Christoph
AU - Einsele, Hermann
AU - Matsumoto, Morio
AU - Wu, Ka Lung
AU - Anderson, Kenneth C.
AU - Jou, Ying Ming
AU - Ganetsky, Alex
AU - Singhal, Anil K.
AU - Richardson, Paul G.
N1 - Publisher Copyright:
© 2020, The Author(s).
PY - 2020/9/1
Y1 - 2020/9/1
N2 - 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.
AB - 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.
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U2 - 10.1038/s41408-020-00357-4
DO - 10.1038/s41408-020-00357-4
M3 - Article
C2 - 32887873
AN - SCOPUS:85090272726
SN - 2044-5385
VL - 10
JO - Blood cancer journal
JF - Blood cancer journal
IS - 9
M1 - 91
ER -