Etentamig Meets PFS, ORR Primary End Points in Triple-Class Exposed R/R Myeloma

Treatment with etentamig (ABBV-383) led to statistically significant and clinically meaningful improvements in objective response rate (ORR) and progression-free survival (PFS) compared with investigator’s choice of standard therapies in patients with triple-class exposed relapsed/refractory multiple myeloma, meeting the dual primary end points of the phase 3 CERVINO trial (NCT06158841).¹

Findings announced by Abbvie showed that at a median follow-up of 11.4 months, etentamig produced an ORR of 74.0% (95% CI, 67.25%-79.97%) vs 45.7% (95% CI, 38.59%-52.91%) with standard available therapies (P < .0001). Etentamig also reduced the risk of disease progression or death by 60% (HR, 0.40; 95% CI, 0.29-0.54; P < .0001), with a benefit observed across all prespecified subgroups.¹

Overall survival (OS) data were immature at the data cutoff, and the 12-month OS rate was 87.9% with etentamig vs 72.0% with standard therapies (HR, 0.48; 95% CI, 0.29-0.77; nominal P = .0012); the prespecified efficacy boundary for OS was not crossed. The findings emerged from the first planned efficacy interim analysis, following which the independent data monitoring committee recommended unblinding the study.

Safety findings were consistent with the known profile of BCMA-directed bispecific antibodies. With etentamig administered using single step-up dosing and every-4-week dosing from treatment initiation, cytokine release syndrome (CRS) occurred in 28.3% of patients treated with the bispecific T-cell engager and was predominantly grade 1 (23.9%), with no grade 3 or higher CRS reported. Immune effector cell–associated neurotoxicity syndrome (ICANS) was reported in 0.9% of patients and was limited to grade 1. Grade 3/4 infections occurred in 27.7% of patients in the etentamig arm vs 19.2% in the standard therapies arm, and treatment-related discontinuations were less frequent with etentamig (3.6% vs 9.6%).

Full results from CERVINO will be presented during a plenary session at the 23rd Annual International Myeloma Society Annual Meeting in September. AbbVie reported plans to discuss the phase 3 findings with global regulatory authorities to determine next steps for etentamig.

“In this heavily pretreated, triple-class exposed patient population, etentamig delivered clinically meaningful improvements in PFS and [ORR], alongside a manageable safety profile characterized by predominantly low-grade cytokine release syndrome,” Peter Voorhees, MD, a member of the Department of Hematology/Medical Oncology (Cancer) at Atrium Health and a professor of cancer medicine at the Wake Forest University School of Medicine in Charlotte, North Carolina, and a CERVINO investigator, stated in a news release. “Together, with its administration and dosing schedule, these findings support etentamig’s role as a BCMA-targeted bispecific treatment option for [patients with] multiple myeloma, with the potential to provide access across a range of treatment settings beyond specialized treatment centers and into outpatient and community-based settings.”

How was the CERVINO trial conducted?

CERVINO was a global, multicenter, randomized, open-label phase 3 trial evaluating etentamig against investigator’s choice of standard therapies in patients with relapsed/refractory multiple myeloma.² Eligible patients needed to be at least 18 years of age with triple-class exposed disease after prior treatment with a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody. At least 2 prior lines of therapy were required, and enrolled patients (n = 393) received a median of 3 prior lines of therapy.^1,2

Other key inclusion criteria comprised an ECOG performance status of 0 to 2 and measurable disease.²

Patients were randomly assigned in a 1:1 ratio to receive either etentamig administered once every 4 weeks following a single step-up dose, or 1 of 3 standard regimens: carfilzomib (Kyprolis) plus dexamethasone; elotuzumab (Empliciti) plus pomalidomide (Pomalyst) and dexamethasone; or selinexor (Xpovio) plus bortezomib (Velcade) and dexamethasone.¹

The dual primary end points were ORR and PFS, and secondary end points included OS, depth of response, measurable residual disease negativity, disease-related symptoms, and physical functioning.

“The phase 3 CERVINO results support the scientific approach behind etentamig and demonstrate the value of designing therapies that address both the biology of multiple myeloma and the practical needs of patients and providers,” Daejin Abidoye, MD, vice president and therapeutic area head, oncology, solid tumor and hematology, at AbbVie, added in a news release.

References

1. AbbVie announces positive 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. News release. AbbVie. September 3, 2026. Accessed September 3, 2026. https://news.abbvie.com/2026-09-03-AbbVie-Announces-Positive-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
2. Study assessing activity of intravenous (IV) etentamig monotherapy versus standard available therapies in adult participants with relapsed or refractory multiple myeloma (CERVINO). ClinicalTrials.gov. Updated August 27, 2026. Accessed September 3, 2026. https://clinicaltrials.gov/study/NCT06158841