Etentamig (ABBV-383) - (CERVINO)

September 3, 2026: AbbVie (NYSE: ABBV) reported positive topline Phase 3 CERVINO (NCT06158841) results for etentamig, an investigational BCMA x CD3 bispecific T-cell engager, in triple-class exposed relapsed/refractory multiple myeloma. In 393 patients with a median of three prior therapy lines and 11.4 months median follow-up, the trial met dual primary endpoints versus investigator’s choice of standard available therapies: ORR was 74.0% vs 45.7% (P<0.0001) and PFS HR was 0.40 (95% CI, 0.29–0.54; P<0.0001). Twelve-month OS was 87.9% vs 72.0% (HR 0.48; nominal P=0.0012), but the prespecified OS boundary was not crossed at cutoff.

Safety with a single step-up dose and monthly dosing from initiation showed grade 3/4 infections in 27.7% vs 19.2%, grade 5 infections in 1.5% vs 3.1%, CRS in 28.3% and mostly grade 1 with no grade 3+, one grade 1 ICANS event (0.9%), and treatment-emergent AE discontinuations of 3.6% vs 9.6%. The IDMC recommended unblinding at the first planned interim efficacy analysis. Full data will be presented in a plenary session at the International Myeloma Society Annual Meeting on September 25, 2026, and AbbVie plans regulatory discussions on next steps.