AbbVie has announced positive topline results from the Phase 3 CERVINO trial evaluating etentamig, an investigational BCMA × CD3 bispecific T-cell engager, in patients with triple-class exposed relapsed or refractory multiple myeloma.
The study met both of its primary endpoints, with etentamig significantly improving objective response rate (ORR) and progression-free survival (PFS) compared with investigator-selected standard available therapies.
Etentamig Achieves 74% Objective Response Rate
CERVINO (NCT06158841) is a global, randomized, open-label Phase 3 study involving patients with relapsed or refractory multiple myeloma who had received at least two previous lines of therapy and had been exposed to a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody.
At the data cutoff, the trial included 393 patients who had received a median of three prior lines of treatment.
After a median follow-up of 11.4 months, the objective response rate was:
- 74.0% with etentamig
- 45.7% with standard available therapies
- The difference was statistically significant (P<0.0001).
Etentamig also significantly improved progression-free survival, producing a 60% reduction in the risk of disease progression or death compared with standard therapies (HR 0.40; 95% CI, 0.29–0.54; P<0.0001).
According to AbbVie, the PFS benefit was observed across all prespecified subgroups evaluated.
Overall Survival Data Remain Immature
At 12 months, overall survival was 87.9% in the etentamig group compared with 72.0% in the standard-therapy group (HR 0.48; 95% CI, 0.29–0.77; nominal P=0.0012).
However, the trial’s prespecified efficacy boundary for overall survival had not been crossed at the time of the analysis, meaning further follow-up will be required to assess the effect on survival.
Following the results of this first planned efficacy interim analysis, the trial’s Independent Data Monitoring Committee recommended that the study be unblinded.
Safety Profile and Monthly Dosing
Etentamig was administered using a single step-up dose followed by dosing once every four weeks.
Grade 3 or 4 infections occurred in 27.7% of patients receiving etentamig, compared with 19.2% of those receiving standard therapies. Grade 5 infections occurred in 1.5% and 3.1% of patients, respectively.
Among patients receiving the single step-up dose, cytokine release syndrome occurred in 28.3%, with most cases classified as grade 1. No grade 3 or higher CRS events were reported.
One patient experienced grade 1 immune effector cell-associated neurotoxicity syndrome (ICANS), with no grade 2 or higher ICANS reported.
Treatment discontinuation due to treatment-emergent adverse events occurred in 3.6% of patients receiving etentamig versus 9.6% receiving standard therapies.
Peter Voorhees, Chief of the Plasma Cell Disorders Division at Atrium Health Levine Cancer Institute and an investigator in CERVINO, 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.”
He added that the treatment’s administration and dosing schedule could potentially expand the use of BCMA-targeted bispecific therapy beyond specialized treatment centers into outpatient and community settings.
About the Phase 3 CERVINO Trial
Patients in CERVINO were randomized 1:1 to receive etentamig or the investigator’s choice of standard available therapy.
Standard treatment options included:
- carfilzomib plus dexamethasone;
- elotuzumab plus pomalidomide and dexamethasone; or
- selinexor plus bortezomib and dexamethasone.
The dual primary endpoints were objective response rate and progression-free survival. Secondary endpoints include overall survival, depth of response, measurable residual disease negativity, disease symptoms, and physical functioning.
What Is Etentamig?
Etentamig is an investigational, second-generation BCMA × CD3 bispecific antibody T-cell engager being developed for multiple myeloma.
The therapy incorporates a low-affinity CD3-binding domain and a high-avidity bivalent BCMA-binding domain. Its design also retains FcRn binding, allowing monthly dosing following a single step-up dose.
Etentamig has not been approved by regulatory authorities.
AbbVie plans to discuss the CERVINO results with global regulatory agencies to determine the next steps for the program. Full Phase 3 results are scheduled to be presented during a plenary session at the 23rd International Myeloma Society Annual Meeting in Glasgow, Scotland, on September 25, 2026.
Read further on OncoDaily: Multiple Myeloma in 2026: Comprehensive Clinical Update
