Etentamig shows significant improvement in multiple myeloma trial
News provided byAbbVie · 2 min read
AbbVie has announced positive results from the Phase 3 CERVINO trial, showing its investigational BCMA x CD3 bispecific T-cell engager, etentamig, significantly improved response rates and progression-free survival in patients with triple-class exposed relapsed/refractory multiple myeloma (RRMM).
The trial, which included 393 patients who had received a median of three prior lines of therapy, met its primary endpoints of objective response rate (ORR) and progression-free survival (PFS). At a median follow-up of 11.4 months, etentamig demonstrated a 74% objective response rate compared to 45.7% for standard available therapies (SAT), with a hazard ratio of 0.40 indicating a 60% risk reduction in disease progression or death.
"These results are significant," said Dr. Peter Voorhees, Chief of the Plasma Cell Disorders Division at Atrium Health Levine Cancer Institute, who was an investigator on the CERVINO study. "Etentamig delivered clinically meaningful improvements in both response rates and progression-free survival, while maintaining a manageable safety profile."
Etentamig's dosing schedule, involving a single step-up dose followed by monthly administration, showed low rates of cytokine release syndrome (CRS) and fatal infections. Grade 3/4 infections occurred in 27.7% of patients receiving etentamig, compared to 19.2% for SAT. Among patients who received a single step-up dose, CRS incidence was low at 28.3%, with only 23.9% experiencing grade 1 events. Notably, there were no grade 3 or higher CRS events.
"These findings support the potential of etentamig to be a differentiated treatment option, enabling broader access to therapy across a range of settings," Dr. Voorhees added.
BCMA-targeted therapies like etentamig have the potential to transform multiple myeloma treatment, but their adoption is limited by adverse events such as CRS and infections. Traditional treatment options often require specialized monitoring and infrastructure, which may limit access for many patients, particularly in community settings.
The Phase 3 CERVINO results underscore AbbVie's commitment to developing innovative therapies that address both the biology of multiple myeloma and the practical needs of patients and providers. Dr. Daejin Abidoye, vice president and therapeutic area head, oncology, solid tumor and hematology at AbbVie, said, "These results reinforce our confidence in etentamig and our broader multiple myeloma strategy, which explores complementary treatment modalities designed to address distinct disease mechanisms and patient needs."
AbbVie plans to discuss the Phase 3 CERVINO results with global regulatory authorities to determine the next steps for etentamig. The company will present full results at the 23rd International Myeloma Society Annual Meeting in Glasgow, Scotland, on September 23-26, 2026.