AbbVie (NYSE: ABBV) has reported that etentamig, its investigational BCMA × CD3 bispecific T-cell engager (TCE), met both dual primary endpoints in the Phase III CERVINO trial, delivering a 74% objective response rate (ORR) and a 60% reduction in the risk of disease progression or death versus investigator's choice of standard available therapies in triple-class exposed relapsed/refractory multiple myeloma (RRMM). The Independent Data Monitoring Committee recommended unblinding the study based on the magnitude of benefit observed at the first planned efficacy interim analysis.
The results put AbbVie on track for a regulatory submission by end of 2026, a timeline the company signaled earlier this year and reaffirmed at its Q2 earnings call in July, where management said a positive interim progression-free survival (PFS) analysis would trigger filings in the same year.
In 393 patients with a median of three prior lines of therapy, etentamig produced an ORR of 74.0% versus 45.7% for standard therapy (P<0.0001) and a PFS hazard ratio of 0.40 (95% CI, 0.29–0.54; P<0.0001), consistent across all pre-specified subgroups. Twelve-month overall survival was 87.9% versus 72.0% (HR 0.48; nominal P=0.0012), though the pre-specified efficacy boundary for OS was not crossed at this data cutoff. The drug was administered once every four weeks from initiation following a single step-up dose — a dosing schedule designed to reduce the cytokine release syndrome (CRS) burden that has constrained adoption of the approved bispecific antibodies in this class.
Among patients receiving the single step-up dose, any-grade CRS occurred in 28.3%, with 23.9% grade 1 and no grade 3 or higher events. Immune effector cell-associated neurotoxicity syndrome (ICANS) was reported in 0.9% of patients (grade 1 only). Grade 3/4 infections were higher with etentamig than standard therapy (27.7% vs. 19.2%), though fatal infections were lower (1.5% vs. 3.1%). Treatment discontinuations due to adverse events were 3.6% with etentamig versus 9.6% with standard therapy.