Phase III ELOQUENT-2 study of Empliciti (elotuzumab) plus lenalidomide/dexamethasone shows continued efficacy in multiple myeloma- Bristol-Myers Squibb

Bristol-Myers Squibb presented four-year follow-up data from the Phase III ELOQUENT-2 study in which Empliciti (elotuzumab) plus lenalidomide/dexamethasone (ELd) continued to demonstrate efficacy in patients with relapsed/refractory multiple myeloma (RRMM), compared to patients treated with lenalidomide/dexamethasone (Ld) alone. The data also showed a safety profile consistent with prior findings. ELd therapy maintained a reduction in the risk of disease progression or death of 29%. At four-years, ELd therapy continued to demonstrate a clinically meaningful and sustained relative improvement of 50% in progression-free survival (PFS) rate, 21%, compared to Ld therapy, 14%. PFS benefits seen in patients receiving ELd therapy were consistent across certain patient subsets and sustained through two-year, three-year and four-year follow-up. Patients with high risk (n=60 ELd, n=66 Ld) showed relative risk reduction of 36% and more than doubling of median PFS (15.2 ELd vs 7.4 Ld) with ELd in comparison to Ld.

Patients receiving ELd therapy demonstrated an overall response rate (ORR) of 79%), compared to 66% (214/325 patients) among patients receiving Ld therapy alone. While OS was not pre-specified for the four-year follow-up, Empliciti in combination with Ld data also demonstrated a median overall survival (OS) benefit of 48 months in favor of ELd versus a median OS of 40 months for Ld, a difference of 22%. Early separation of OS Kaplan Meier survival curves was maintained over time in favor of ELd versus Ld. The rates of adverse events (AE) were similar between patients receiving ELd or Ld therapy and consistent with those reported at two- and three-year follow-up. The results were presented during the 22nd Congress of the European Hematology Association and offer the longest follow-up efficacy and safety data of an Immuno-Oncology agent.