AbbVie’s etentamig delivers significant Phase 3 benefit in relapsed or refractory multiple myeloma

AbbVie has reported positive topline findings from the Phase 3 CERVINO study of etentamig in patients with relapsed or refractory multiple myeloma who had previously been exposed to three major treatment classes.

The investigational BCMA x CD3 bispecific T cell engager was compared with investigator selected standard available therapies in patients previously treated with a proteasome inhibitor, an immunomodulatory drug and an anti CD38 monoclonal antibody. CERVINO met both of its primary endpoints, demonstrating significant improvements in objective response rate and progression free survival.

Complete findings from the study are scheduled to be presented during a plenary session at the 23rd International Myeloma Society Annual Meeting in Glasgow, Scotland, which will take place from September 23 to 26, 2026.

At the time of the data cutoff, 393 patients had been enrolled in CERVINO and participants had received a median of three previous lines of treatment. Following a median follow up period of 11.4 months, etentamig showed statistically significant and clinically meaningful activity while maintaining a manageable safety profile.

The objective response rate reached 74.0% with etentamig, with a 95% confidence interval of 67.25% to 79.97%, compared with 45.7% for standard available therapies, with a 95% confidence interval of 38.59% to 52.91%. The difference was statistically significant at P<0.0001.

Progression free survival was also significantly improved with etentamig compared with standard available therapies, producing a hazard ratio of 0.40, with a 95% confidence interval of 0.29 to 0.54 and P<0.0001. This corresponds to a 60% reduction in the risk of disease progression or death. The benefit was observed across all prespecified subgroups evaluated.

Overall survival at 12 months was 87.9% in the etentamig group compared with 72.0% among patients receiving standard available therapies. The hazard ratio was 0.48, with a 95% confidence interval of 0.29 to 0.77 and a nominal P value of 0.0012. However, the prespecified efficacy boundary for overall survival had not been crossed at the data cutoff.

Etentamig was administered using a single step up dose followed by monthly dosing from treatment initiation. Grade 3 or 4 infections were reported in 27.7% of patients receiving etentamig and 19.2% of those treated with standard available therapies. Fatal grade 5 infections occurred in 1.5% and 3.1% of patients, respectively.

Among participants who received the single step up dose, cytokine release syndrome occurred in 28.3% of patients. Most cases were grade 1, which accounted for 23.9%, and no events of grade 3 or above were reported. Immune effector cell associated neurotoxicity syndrome occurred in one patient, representing 0.9% of the group, and was classified as grade 1. No grade 2 or higher cases were observed.

Treatment discontinuation because of treatment emergent adverse events was reported in 3.6% of patients receiving etentamig compared with 9.6% of those receiving standard available therapies.

The findings came from the first planned interim efficacy analysis of CERVINO. Following the observed treatment benefit, the Independent Data Monitoring Committee recommended that the study be unblinded.

Dr. Peter Voorhees, chief of the Plasma Cell Disorders Division at Atrium Health Levine Cancer Institute and a CERVINO investigator, said the findings showed clinically meaningful gains in progression free survival and response among a heavily treated population previously exposed to three treatment classes. He also highlighted the manageable safety profile, including predominantly low grade cytokine release syndrome.

Voorhees said the treatment’s administration and dosing schedule, together with the efficacy and safety findings, support its potential as a BCMA targeted bispecific therapy that could be delivered across a broader range of treatment environments, including outpatient and community care settings rather than only specialised centres.

Although BCMA directed bispecific antibodies and CAR T therapies have changed the treatment landscape for multiple myeloma, broader adoption can be restricted by cytokine release syndrome, neurotoxicity, infections and requirements for specialised monitoring and treatment infrastructure. These factors can make the therapies more difficult to access, particularly for patients receiving care in community settings.

Treatment options also become progressively more limited as multiple myeloma relapses, creating continued demand for additional therapies that can be used across different healthcare settings.

Daejin Abidoye, M.D., vice president and therapeutic area head for oncology, solid tumor and hematology at AbbVie, said the CERVINO findings support the scientific rationale behind etentamig. He said the results demonstrate the potential value of treatments designed to address both the underlying biology of multiple myeloma and practical considerations for patients and healthcare providers, including safety, dosing convenience and suitability for outpatient and community care.

Abidoye added that the results strengthen AbbVie’s confidence in etentamig and its wider multiple myeloma strategy, which includes complementary T cell engagers, targeted small molecules and combination approaches intended to address different disease mechanisms and patient requirements over time.

AbbVie intends to discuss the CERVINO results with regulatory authorities worldwide to determine the next development steps for etentamig.

The CERVINO Phase 3 results will be presented on Friday, September 25, 2026 at 3 p.m. during a plenary session at the International Myeloma Society Annual Meeting. The presentation will cover etentamig compared with investigator selected standard available therapies in patients with triple class exposed relapsed or refractory multiple myeloma.

Etentamig remains investigational and has not received approval from regulatory authorities worldwide.

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AbbVie, bispecific antibodies, cancer research, clinical trials, hematology, multiple myeloma, Oncology, pharma news