Positive topline results from the Phase 3 CERVINO trial showed etentamig significantly improved response rate and PFS in patients with triple-class exposed relapsed/refractory multiple myeloma.

On Thursday, September 3, AbbVie announced positive topline results from the Phase 3 CERVINO trial in a press release.
 

The study evaluated whether etentamig (an investigational BCMA × CD3 bispecific T-cell engager) improves treatment outcomes compared with investigators’ choice of standard available therapies (SAT) in patients with triple-class exposed relapsed/refractory multiple myeloma (RRMM). The study assessed objective response rate (ORR) and progression-free survival (PFS) as its dual primary endpoints.
 
According to AbbVie, “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.”
 
The Phase 3 CERVINO trial is a global, randomized, open-label study involving 393 patients with RRMM who had received at least two prior lines of therapy, including a proteasome inhibitor, immunomodulatory drug, and anti-CD38 monoclonal antibody; patients received etentamig once every four weeks (Q4W) or investigators' choice of SAT. 

At a median follow-up of 11.4 months, etentamig produced a higher ORR than SAT (74.0% vs. 45.7%; P<0.0001) and improved PFS (HR 0.40; 95% CI, 0.29–0.54; P<0.0001); 12-month overall survival (OS) was 87.9% vs. 72.0%, although the prespecified OS efficacy boundary was not crossed at the data cutoff.
 
Etentamig was administered with a single step-up dose followed by monthly Q4W dosing from initiation; among patients receiving the single step-up dose, cytokine release syndrome (CRS) occurred in 28.3%, predominantly grade 1 (23.9%), with no grade ≥3 CRS, while grade 3/4 infections occurred in 27.7% of etentamig-treated patients versus 19.2% with SAT, and grade 5 infections occurred in 1.5% vs. 3.1%, respectively.
 
Etentamig demonstrated a higher ORR and longer PFS than investigators’ choice of SAT in patients with triple-class exposed RRMM, with ORR of 74.0% vs. 45.7% and a PFS hazard ratio of 0.40 at a median follow-up of 11.4 months. With a single step-up dose followed by Q4W dosing, CRS was predominantly grade 1 and no grade ≥3 CRS was reported among patients receiving the single step-up dose; however, grade 3/4 infections were more frequent with etentamig than SAT, and the prespecified OS efficacy boundary had not been crossed at the data cutoff.
 
Chief of the Plasma Cell Disorders Division at Atrium Health Levine Cancer Institute and CERVINO study investigator, Peter Voorhees, MD, said: "In this heavily pre-treated, triple-class exposed patient population, etentamig delivered clinically meaningful improvements in progression-free survival and response rates, alongside a manageable safety profile characterized by predominantly low-grade cytokine release syndrome."
 
"Together, with its administration and dosing schedule, these findings support etentamig's role as a BCMA-targeted bispecific treatment option for multiple myeloma patients, with the potential to provide access across a range of treatment settings beyond specialized treatment centers and into outpatient and community-based settings," he added.
 
 
Reference:
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. Abbvie press release. September 3, 2026.