Abbvie Announces Topline Results From The Phase 3 Cervino Trial Showing Etentamig Significantly Improved Response Rate And Progression-Free Survival In Patients With Relapsed/Refractory Multiple Myeloma; Etentamig Achieves 74% Orr And 60% Risk Reduction In Phase 3 Cervino Trial; Etentamig Demonstrates Low Rates Of Cytokine Release Syndrome And Fatal Infections; Phase 3 Cervino Study Met Dual Primary Endpoints; Full Results To Be Presented Sept 23-26

• Etentamig, an investigational asset, achieved a significantly improved objective response rate (ORR, 74%) and a 60% risk reduction in disease progression or death (progression-free survival, hazard ratio 0.40) versus investigator's choice of standard available therapies
• Etentamig demonstrated low rates of cytokine release syndrome (CRS) and fatal infections with monthly dosing (Q4W) from initiation following a single step-up dose
• Etentamig's dosing schedule and clinical profile may offer a differentiated treatment option for patients and providers
• Results support the potential of etentamig, a second-generation BCMA-directed T-cell engager, to enable treatment across a range of settings, including outpatient and community-based care

NORTH CHICAGO, Ill., Sept. 3, 2026 /PRNewswire/ -- AbbVie (NYSE:ABBV) announced positive topline results from the Phase 3 CERVINO study1 evaluating etentamig, an investigational BCMA x CD3 bispecific T-cell engager, versus standard available therapies (SAT) in patients with triple-class exposed (proteasome inhibitor, immunomodulatory drug and anti-CD38 monoclonal antibody) relapsed/refractory multiple myeloma (RRMM). The study met its dual primary endpoints of objective response rate (ORR) and progression-free survival (PFS). Full results will be presented in a plenary session at the 23rd International Myeloma Society Annual Meeting, taking place September 23-26, 2026, in Glasgow, Scotland.

At the data cutoff, the Phase 3 CERVINO trial included 393 patients who had received a median of three prior lines of therapy. At the median follow-up of 11.4 months, etentamig demonstrated statistically significant and clinically meaningful efficacy with a manageable safety profile:

• Significantly higher ORR with etentamig vs. SAT (74.0% [95% CI, 67.25–79.97] vs. 45.7% [95% CI, 38.59–52.91]; P<0.0001).2
• Significantly improved PFS with etentamig vs. SAT (HR, 0.40; 95% CI, 0.29–0.54; P<0.0001). The PFS benefit was observed across all pre-specified subgroups evaluated.2
• 12-month overall survival (OS) was 87.9% for etentamig vs. 72.0% for SAT (HR, 0.48; 95% CI: 0.29–0.77; nominal P=0.0012); prespecified efficacy boundary for OS was not crossed at data cutoff.2
• With a single step-up dose (SUD) and monthly (Q4W) dosing from initiation, etentamig demonstrated a potentially differentiated safety profile. Grade 3/4 infections occurred in 27.7% and 19.2% of patients receiving etentamig and SAT, respectively. Fewer grade 5 infections occurred with etentamig (1.5%) vs. SAT (3.1%). Among patients receiving a single step-up dose, the incidence of cytokine release syndrome (CRS) was low (28.3%) and predominantly grade 1 (23.9%) with no grade 3 or higher events reported. One patient experienced immune effector cell-associated neurotoxicity syndrome (ICANS) (0.9%, grade 1) with no grade 2 or higher events reported. Discontinuations related to treatment-emergent adverse events were low for etentamig vs. SAT (3.6% vs. 9.6%).2

This was the first planned efficacy interim analysis of the CERVINO study and, based on the significant benefit, the Independent Data Monitoring Committee (IDMC) recommended unblinding the study.