Scientific publications

Elotuzumab Plus Pomalidomide and Dexamethasone for Relapsed/Refractory Multiple Myeloma: Final Overall Survival Analysis From the Randomized Phase II ELOQUENT-3 Trial

Jan 20, 2023 | Magazine: Journal of Clinical Oncology

Meletios A Dimopoulos  1 , Dominik Dytfeld  2 , Sebastian Grosicki  3 , Philippe Moreau  4 , Naoki Takezako  5 , Mitsuo Hori  6 , Xavier Leleu  7 , Richard LeBlanc  8 , Kenshi Suzuki  9 , Marc S Raab  10 , Paul G Richardson  11 , Mihaela Popa McKiver  12 , Ying-Ming Jou  12 , David Yao  12 , Prianka Das  12 , Jesús San-Miguel  13

Purpose: In the phase II ELOQUENT-3 trial ( identifier: NCT02654132), elotuzumab combined with pomalidomide/dexamethasone (EPd) significantly improved progression-free survival (PFS) versus pomalidomide/dexamethasone (Pd) in patients with relapsed/refractory multiple myeloma (RRMM) previously treated with lenalidomide and a proteasome inhibitor (PI). Here, we present the final overall survival (OS) results.

Methods: Patients with RRMM who had received ≥ 2 prior lines of therapy, with disease refractory to last therapy and either refractory or relapsed and refractory to lenalidomide and a PI were randomly assigned (1:1) to receive EPd or Pd. The primary end point was PFS per investigator assessment. ORR and OS were secondary end points planned to be tested hierarchically.

Results: A total of 117 patients were randomly assigned to EPd (n = 60) and Pd (n = 57). Among treated patients (EPd 60, Pd 55), there were 37 (61.7%) deaths in the EPd group and 41 (74.5%) in the Pd group, most commonly because of disease progression (EPd 41.7%, Pd 49.1%). Median (95% CI) OS was significantly improved with EPd (29.8 [22.9 to 45.7] months) versus Pd (17.4 [13.8 to 27.7] months), with a hazard ratio of 0.59 (95% CI, 0.37 to 0.93; P = .0217). OS benefit with EPd was observed in most patient subgroups. The safety profile of EPd was consistent with prior reports with no new safety signals detected.

Conclusion: EPd demonstrated a statistically significant improvement in OS versus Pd in patients with RRMM previously treated with lenalidomide and a PI who had disease refractory to last therapy. 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.

CITATION  J Clin Oncol. 2023 Jan 20;41(3):568-578.  doi: 10.1200/JCO.21.02815. Epub 2022 Aug 12.