Bristol-Myers Squibb Company and AbbVie announced that Empliciti (elotuzumab), in combination with Revlimid (lenalidomide) and dexamethasone, has been approved by the European Commission (EC) for the treatment of relapsed and refractory multiple myeloma (MM) patients who have had at least one prior therapy.
Empliciti is the first immunostimulatory to be approved by the European Union for the treatment of multiple myeloma.
The drug targets the cell-surface glycoprotein signaling the lymphocyte activation molecule family member 7 (SLAM7) expressed on myeloma cells and natural killer cells in the immune system. It then activates the natural killer cells and tags myeloma cells for natural killer-mediated destruction.
“Empliciti represents an important new treatment option for patients with multiple myeloma and healthcare providers who are treating this cancer in Europe,” said Dr. Michael Severino, AbbVie’s executive vice president of research and development and chief scientific officer in a press release. “AbbVie is proud to be part of the team that developed Empliciti and pleased to be partnering with Bristol-Myers Squibb to bring this new therapy to previously treated multiple myeloma patients.”
The approval was based on the ELOQUENT-2 study, a Phase 3, open-label, randomized trial that aimed to evaluate Empliciti in combination with Revlimid and dexamethasone (ERd), versus Revlimid and dexamethasone (Rd) alone, in patients with relapsed or refractory multiple myeloma. The study followed 646 people who had received one to three prior therapies.
ELOQUENT-2 results revealed that ERd combo regimen improved the progression-free survival rate in 21% of participants at one year, 50% at two years, and 53% at three years of follow-up, when compared to Rd alone. The overall response rate was also significantly increased with the ERd therapy (78.5% versus 65.5 percent in the Rd group). Extended follow-up analysis showed that patients given ERd could delay followup by roughly a full year compared to Rd treated patients.
Despite the improvement in progression-free survival, ERd therapy had more instances of adverse reactions than the Rd regimen. Side effects included diarrhea, fatigue, cough, upper respiratory tract infection, headache, and pneumonia.
But the study’s investigator Dr. Antonio Palumbo, who is chief of the Myeloma Unit, Department of Oncology at the University of Torino in Italy, said that because multiple myeloma is largely incurable and often characterized with a cycle of remission and relapse, the critical need for new therapies that work in unique and innovative ways is high priority.
“In clinical trials, Empliciti in combination with lenalidomide and dexamethasone delivered a significant benefit in progression-free survival compared to lenalidomide and dexamethasone alone, which could make a meaningful difference in the lives of patients struggling with this serious disease,” Palumbo said.
Sarper Diler, president of Myeloma Patients Europe, said the EC’s decision to approve the combination is excellent news.
“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,” Dilar said.