Elotuzumab plus pomalidomide and dexamethasone (EPd) improved overall survival (OS) among patients with relapsed/refractory multiple myeloma (RRMM), according to the final OS analysis of the phase 2 ELOQUENT-3 study published in the Journal of Clinical Oncology.
It was previously reported that EPd improved progression-free survival (PFS) compared with pomalidomide plus dexamethasone (Pd) in the ELOQUENT-3 trial (hazard ratio [HR], 0.54; 95% CI, 0.34-0.86; P =.008). This report is of the final OS analysis.
The open-label, multicenter, phase 2 ELOQUENT-3 trial randomly assigned 117 patients with RRMM who had previously received lenalidomide plus a proteasome inhibitor to receive EPd or Pd. The primary endpoint was PFS and secondary endpoints were OS and objective response rate (ORR).
EPd significantly prolonged OS, with a median of 29.8 months compared with 17.4 months with Pd (HR, 0.59; 95% CI, 0.37-0.93; P =.0217). The 24-month OS were 63% and 44%, and the 36-month OS were 39% and 29% with EPd and Pd, respectively.
Nearly all subgroups favored the addition of elotuzumab, including age older than 75 (HR, 0.36; 95% CI, 0.13-1.01) and 4 prior lines of therapy or more (HR, 0.42; 95% CI, 0.20-0.89). However, the authors acknowledged that many subgroups had small sample sizes.
There were no new safety signals in this analysis. The rates of grade 3-4 AEs were similar between the groups, at 60.0% with EPd and 61.8% with Pd.
The authors concluded that “in this setting, ELOQUENT-3 is the first randomized study of a triplet regimen incorporating a monoclonal antibody and Pd to improve both PFS and OS significantly.”
Disclosures: This study was supported by Bristol Myers Squibb and AbbVie Biotherapeutics. Please see the original reference for a full list of disclosures.
Dimopoulos MA, Dytfeld D, Grosicki S, et al. Elotuzumab plus pomalidomide and dexamethasone for relapsed/refractory multiple myeloma: final overall survival analysis from the randomized phase II ELOQUENT-3 trial. J Clin Oncol. 2023;41:568-578. doi: 10.1200/JCO.21.02815