WASHINGTON (dpa-AFX) - AbbVie (ABBV) on Thursday announced positive topline results from the Phase 3 CERVINO trial evaluating investigational etentamig in patients with relapsed/refractory multiple myeloma.
The study met both primary endpoints, with etentamig achieving a significantly higher objective response rate of 74.0%, compared with 45.7% for investigator's choice of standard available therapies. It also reduced the risk of disease progression or death by 60%, with a progression-free survival hazard ratio of 0.40.
At a median follow-up of 11.4 months, 12-month overall survival was 87.9% for etentamig versus 72.0% for standard therapies. The trial included 393 patients who had received a median of three prior lines of therapy.
Etentamig, a second-generation BCMA x CD3 bispecific T-cell engager, showed a potentially differentiated safety profile with monthly dosing following a single step-up dose. Cytokine release syndrome occurred in 28.3% of patients receiving the step-up dose, predominantly at Grade 1, with no Grade 3 or higher events reported.
AbbVie said the results support the potential for treatment in outpatient and community-based settings. The company plans to discuss the results with global regulatory authorities to determine next steps.
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