Prolonging OS remains an unmet need in RRMM. In ELOQUENT-2, elotuzumab plus lenalidomide/dexamethasone (ERd) significantly improved PFS versus lenalidomide/dexamethasone (Rd) in patients with RRMM and 1–3 prior LoTs. Results that are reported are 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 total number of patients with RRMM and 1–3 prior LoTs were randomized equally 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, which was consistently observed across key predefined subgroups. No additional safety signals with ERd at extended follow-up were reported.
The findings of the study concluded that the 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.