North Chicago, Illinois, USA, September 3, 2026
AbbVie has announced positive topline results from the Phase 3 CERVINO trial, showing that investigational etentamig significantly improved objective response rate (ORR) and progression-free survival (PFS) compared with standard available therapies in patients with relapsed or refractory multiple myeloma (RRMM). The study met both of its dual primary endpoints in a heavily pretreated population previously exposed to a proteasome inhibitor, immunomodulatory drug and anti-CD38 monoclonal antibody. Etentamig achieved an ORR of 74.0%, compared with 45.7% for investigator’s choice of standard available therapies, while PFS showed a 60% reduction in the risk of disease progression or death, with a hazard ratio of 0.40. The results strengthen the clinical development program for etentamig, a second-generation BCMA × CD3 bispecific T-cell engager, although the investigational therapy has not been approved by regulatory authorities.
AbbVie Etentamig Shows Strong Phase 3 Efficacy
The global, randomized, open-label CERVINO study enrolled 393 patients with relapsed or refractory multiple myeloma who had received a median of three previous lines of therapy. Patients were randomized to receive either etentamig once every four weeks or investigator-selected standard available therapies, including combinations involving carfilzomib, elotuzumab, pomalidomide, selinexor or bortezomib. At a median follow-up of 11.4 months, etentamig produced a statistically significant and clinically meaningful improvement in both primary efficacy measures. The ORR was 74.0% versus 45.7%, with P<0.0001, while the PFS hazard ratio was 0.40, also with P<0.0001, demonstrating a substantial reduction in the risk of disease progression or death. The PFS benefit was reported across all prespecified subgroups evaluated. The topline findings also showed a numerical overall survival advantage. Twelve-month overall survival was 87.9% with etentamig compared with 72.0% with standard available therapies, corresponding to a hazard ratio of 0.48. However, AbbVie noted that the prespecified efficacy boundary for overall survival had not been crossed at the data cutoff, making the OS result an important but not yet definitive finding. The Independent Data Monitoring Committee recommended unblinding the study following the significant benefit observed in the planned interim efficacy analysis.
BCMA-Targeted Therapy Uses Monthly Dosing
Etentamig is designed as a BCMA × CD3 bispecific T-cell engager, directing T cells toward malignant plasma cells expressing B-cell maturation antigen (BCMA). The investigational therapy incorporates a low-affinity CD3 binding domain, a bivalent BCMA-binding domain and retained FcRn binding intended to support monthly dosing following a single step-up dose. The optimized dosing approach is particularly relevant because treatment convenience and toxicity management remain important considerations for patients receiving T-cell-engaging therapies in multiple myeloma. The safety findings from CERVINO also provided encouraging signals. With the single step-up dose followed by monthly dosing, cytokine release syndrome (CRS) occurred in 28.3% of patients, with most events being Grade 1 and no Grade 3 or higher CRS reported. One patient experienced Grade 1 immune effector cell-associated neurotoxicity syndrome (ICANS), with no Grade 2 or higher events reported. Grade 3/4 infections occurred in 27.7% of etentamig-treated patients compared with 19.2% receiving standard therapies, while Grade 5 infections were reported in 1.5% versus 3.1%, respectively. Treatment-emergent adverse-event discontinuations were also lower with etentamig at 3.6% versus 9.6%.
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AbbVie Advances Multiple Myeloma Development Program
The CERVINO findings are significant because patients with triple-class exposed RRMM have limited treatment options and continue to face substantial unmet medical needs. Although BCMA-directed bispecific antibodies and CAR-T therapies have transformed multiple myeloma treatment, challenges associated with CRS, infections, neurotoxicity and specialized monitoring requirements can affect treatment delivery, particularly outside major treatment centers. AbbVie said etentamig’s efficacy, monthly dosing and safety profile could potentially support use in outpatient and community-based care settings. AbbVie plans to discuss the CERVINO findings with global regulatory authorities to determine next steps. Full Phase 3 results are scheduled for presentation at a plenary session of the International Myeloma Society Annual Meeting in Glasgow, Scotland, on September 25, 2026. Until regulatory review is completed, etentamig remains an investigational therapy.
Source: AbbVie press release
