BMS and AbbVie announce EC approval of Empliciti for the treatment of multiple myeloma in adults who have received at least one prior therapy

First and only immunostimulatory antibody approved in the European Union for multiple myeloma.

The approval is based on data from the randomized, open-label, Phase III ELOQUENT-2 study, which evaluated Empliciti in combination with lenalidomide and dexamethasone (ERd) versus lenalidomide and dexamethasone (Rd) alone. The co-primary endpoints of this study, progression-free survival (PFS) as assessed by hazard ratio (HR) and overall response rate (ORR), were achieved, with extended follow-up data showing a 53% relative improvement in PFS rate at 3 years (23% versus 15%). Additionally, a pre-specified interim analysis for overall survival (OS) found a positive trend favoring the Empliciti combination versus Rd alone (HR=0.77 [95% CI: 0.61, 0.97, p=0.0257]), though at the time of the interim analysis, the OS endpoint had not reached the pre-determined threshold for statistical significance. Patients will continue to be followed for survival, and the final analysis is pending.

“At BMS, we are committed to delivering pioneering medicines with the goal of revolutionizing the way cancer is treated for patients who inspire our work each and every day,” said Emmanuel Blin, senior vice president and head of Commercialization, Policy and Operations, BMS. “With the approval of Empliciti in the EU, we are proud to extend our Immuno-Oncology science to multiple myeloma patients in Europe who have received at least one prior therapy.”

“Today’s decision of the European Commission is excellent news for relapsed and refractory multiple myeloma patients,” said Sarper Diler, President of Myeloma Patients Europe. “Multiple myeloma has had a difficult-to-treat history, and at Myeloma Patients Europe, we are committed to ensuring these patients living in any European country are able to access new, innovative medicines, like Empliciti.”

“Empliciti represents an important new treatment option for patients with multiple myeloma and healthcare providers who are treating this cancer in Europe,” said Michael Severino, executive vice president of R&D and chief scientific officer, AbbVie. “AbbVie is proud to be part of the team that developed Empliciti and pleased to be partnering with BMS to bring this new therapy to previously treated multiple myeloma patients.”