AbbVie’s experimental therapy etentamig met its primary endpoints in a late-stage clinical trial evaluating its use in patients with relapsed or refractory multiple myeloma.
The Phase 3 CERVINO study, which enrolled 393 patients, compared etentamig against standard available therapies. Participants had received a median of three prior treatment lines and were previously exposed to proteasome inhibitors, immunomodulatory drugs and anti-CD38 monoclonal antibodies. Etentamig is administered monthly following an initial step-up dose.
After a median follow-up of 11.4 months, etentamig demonstrated a 74.0% objective response rate, compared with 45.7% for standard therapies, with a statistically significant difference (P < 0.0001). The investigational therapy also reduced the risk of disease progression or death by 60%, with a hazard ratio of 0.40 (95% CI, 0.29–0.54; P < 0.0001).
At 12 months, the overall survival rate was 87.9% for patients receiving etentamig versus 72.0% for those on standard therapies, though the prespecified efficacy boundary for overall survival was not met at the data cutoff. Safety data showed grade 3/4 infections in 27.7% of etentamig patients compared with 19.2% on standard therapies, while fatal infections occurred in 1.5% versus 3.1%, respectively.
Cytokine release syndrome was reported in 28.3% of etentamig patients, predominantly grade 1 events, with no grade 3 or higher occurrences. One patient experienced grade 1 immune effector cell-associated neurotoxicity syndrome. Treatment discontinuations due to adverse events were lower with etentamig at 3.6%, versus 9.6% for standard therapies.
Full results will be presented at the International Myeloma Society Annual Meeting in Glasgow, Scotland, on September 25, 2026. AbbVie plans to discuss the findings with global regulators.
