Elotuzumab, lenalidomide, and dexamethasone in RRMM: final overall survival results from the phase 3 randomized ELOQUENT-2 study
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Elotuzumab, lenalidomide, and dexamethasone in RRMM: final overall survival results from the phase 3 randomized ELOQUENT-2 study. / Dimopoulos, Meletios A; Lonial, Sagar; White, Darrell; Moreau, Philippe; Weisel, Katja; San-Miguel, Jesus; Shpilberg, Ofer; Grosicki, Sebastian; Špička, Ivan; Walter-Croneck, Adam; Magen, Hila; Mateos, Maria-Victoria; Belch, Andrew; Reece, Donna; Beksac, Meral; Spencer, Andrew; Oakervee, Heather; Orlowski, Robert Z; Taniwaki, Masafumi; Röllig, Christoph; Einsele, Hermann; Matsumoto, Morio; Wu, Ka Lung; Anderson, Kenneth C; Jou, Ying-Ming; Ganetsky, Alex; Singhal, Anil K; Richardson, Paul G.
In: BLOOD CANCER J, Vol. 10, No. 9, 04.09.2020, p. 91.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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TY - JOUR
T1 - Elotuzumab, lenalidomide, and dexamethasone in RRMM: 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
PY - 2020/9/4
Y1 - 2020/9/4
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.
U2 - 10.1038/s41408-020-00357-4
DO - 10.1038/s41408-020-00357-4
M3 - SCORING: Journal article
C2 - 32887873
VL - 10
SP - 91
JO - BLOOD CANCER J
JF - BLOOD CANCER J
SN - 2044-5385
IS - 9
ER -