AbbVie reports Phase 3 multiple-myeloma win, positioning etentamig for a competitive BCMA market

AbbVie said its investigational BCMA×CD3 bispecific T-cell engager, etentamig (formerly ABBV-383), met both primary endpoints in the Phase 3 CERVINO trial for heavily pretreated relapsed/refractory multiple myeloma.

At 11.4 months’ median follow-up, objective response rate was 74.0% with etentamig versus 45.7% with investigator’s-choice standard therapies. Progression-free survival also improved significantly (hazard ratio 0.40), implying a 60% lower risk of progression or death in the study period.

Twelve-month overall survival was 87.9% for etentamig versus 72.0% for standard therapy, although the prespecified statistical threshold for overall-survival benefit had not been crossed at the data cutoff.

AbbVie emphasized a potentially differentiated dosing and tolerability profile:
monthly IV administration after a single step-up dose; cytokine-release syndrome occurred in 28.3% of patients and was mostly grade 1, with no grade 3+ events reported. Fatal infections were 1.5%, versus 3.1% in the control arm, though severe grade 3/4 infections remained notable.

The company plans to meet global regulators to determine next steps. Etentamig is not yet approved.

If approved, it would enter a crowded BCMA-directed myeloma market, competing particularly with Johnson & Johnson’s marketed bispecific Tecvayli (teclistamab), as well as other antibody, cellular-therapy and combination-treatment options. AbbVie’s commercial case rests on strong late-line efficacy plus the convenience of once-monthly dosing and lower apparent cytokine-release toxicity.