AbbVie announced positive topline results from the Phase 3 CERVINO trial evaluating etentamig, an investigational BCMA x CD3 bispecific T-cell engager, in patients with relapsed or refractory multiple myeloma.
The trial, which enrolled 393 patients who had received a median of three prior lines of therapy, met its primary endpoints with statistically significant improvements over standard available treatments. After a median follow-up of 11.4 months, the objective response rate was 74.0% for etentamig compared with 45.7% for standard therapies, with a p-value of less than 0.0001. Progression-free survival showed a 60% reduction in the risk of disease progression or death, reflected in a hazard ratio of 0.40 (95% CI: 0.29–0.54; p < 0.0001).
Secondary endpoints also indicated benefits, including a 12-month overall survival rate of 87.9% for etentamig versus 72.0% for standard therapies, though the prespecified efficacy boundary for overall survival was not crossed at the data cutoff. The study’s full results are scheduled for presentation at the International Myeloma Society Annual Meeting in Glasgow on September 25, 2026.
Safety data showed higher rates of grade 3/4 infections with etentamig (27.7%) compared with standard therapies (19.2%), though fatal infections were less frequent (1.5% vs. 3.1%). Cytokine release syndrome occurred in 28.3% of patients, predominantly grade 1 (23.9%), with no grade 3 or higher events reported. Treatment discontinuations due to adverse events were lower with etentamig (3.6%) than with standard therapies (9.6%).
AbbVie plans to discuss the findings with global regulatory authorities to determine next steps for the drug’s development pathway.
