On September 3, 2026 AbbVie (NYSE: ABBV) reported positive topline results from the Phase 3 CERVINO study1 evaluating etentamig, an investigational BCMA x CD3 bispecific T-cell engager, versus standard available therapies (SAT) in patients with triple-class exposed (proteasome inhibitor, immunomodulatory drug and anti-CD38 monoclonal antibody) relapsed/refractory multiple myeloma (RRMM). 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.
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At the data cutoff, the Phase 3 CERVINO trial included 393 patients who had received a median of three prior lines of therapy. At the median follow-up of 11.4 months, etentamig demonstrated statistically significant and clinically meaningful efficacy with a manageable safety profile:
Significantly higher ORR with etentamig vs. SAT (74.0% [95% CI, 67.25–79.97] vs. 45.7% [95% CI, 38.59–52.91]; P<0.0001).2
Significantly improved PFS with etentamig vs. SAT (HR, 0.40; 95% CI, 0.29–0.54; P<0.0001). The PFS benefit was observed across all pre-specified subgroups evaluated.2
12-month overall survival (OS) was 87.9% for etentamig vs. 72.0% for SAT (HR, 0.48; 95% CI: 0.29–0.77; nominal P=0.0012); prespecified efficacy boundary for OS was not crossed at data cutoff.2
With a single step-up dose (SUD) and monthly (Q4W) dosing from initiation, etentamig demonstrated a potentially differentiated safety profile. Grade 3/4 infections occurred in 27.7% and 19.2% of patients receiving etentamig and SAT, respectively. Fewer grade 5 infections occurred with etentamig (1.5%) vs. SAT (3.1%). Among patients receiving a single step-up dose, the incidence of cytokine release syndrome (CRS) was low (28.3%) and predominantly grade 1 (23.9%) with no grade 3 or higher events reported. One patient experienced immune effector cell-associated neurotoxicity syndrome (ICANS) (0.9%, grade 1) with no grade 2 or higher events reported. Discontinuations related to treatment-emergent adverse events were low for etentamig vs. SAT (3.6% vs. 9.6%).2
This was the first planned efficacy interim analysis of the CERVINO study and, based on the significant benefit, the Independent Data Monitoring Committee (IDMC) recommended unblinding the study.
"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," said Dr. Peter Voorhees, Chief, Plasma Cell Disorders Division at Atrium Health Levine Cancer Institute and an investigator on the CERVINO study. "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."
While BCMA-directed bispecific antibodies and CAR-T therapies have transformed multiple myeloma treatment, their adoption remains limited by adverse events such as CRS, neurotoxicity and infections, as well as the need for specialized monitoring and treatment infrastructure.3,4,5 These may limit access for many patients, particularly in community settings. As the disease relapses and available treatment options become increasingly limited, there remains a critical unmet need for additional therapy options across a range of treatment settings.3,4,5
"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 through a manageable safety profile, a convenient dosing schedule and the potential for treatment in outpatient and community-based care settings," said Daejin Abidoye, M.D., vice president and therapeutic area head, oncology, solid tumor and hematology, AbbVie. "These results underscore our confidence in etentamig and our broader multiple myeloma strategy, which explores complementary T-cell engagers, targeted small molecules and rational combinations designed to address distinct disease mechanisms and patient needs over time."
AbbVie plans to discuss the Phase 3 CERVINO results with global regulatory authorities to determine next steps for etentamig.
IMS Presentation Details:
Abstract Title
Date/Time
Session
CERVINO: Phase 3 Results of Etentamig
vs. Investigator’s Choice of Standard
Available Therapies in Triple-Class
Exposed Relapsed or Refractory Multiple
Myeloma (RRMM)
Friday, September
25, 2026; 3 p.m.
PLENARY SESSION
Etentamig is an investigational asset and has not been approved for use by global regulatory authorities.
About the CERVINO Study1
CERVINO (NCT06158841) is a global, Phase 3, multicenter, randomized, open-label study evaluating etentamig versus investigator’s choice of standard available therapies (SAT) in patients with relapsed/refractory multiple myeloma (RRMM) who have received at least two prior lines of therapy, including exposure to a proteasome inhibitor, an immunomodulatory drug and an anti-CD38 monoclonal antibody. Patients were randomized 1:1 to receive etentamig administered once every four weeks (Q4W) or SAT, including carfilzomib plus dexamethasone, elotuzumab plus pomalidomide and dexamethasone, or selinexor plus bortezomib and dexamethasone. Etentamig was administered using an optimized dosing strategy that incorporates a single step-up dose followed by monthly (Q4W) dosing from initiation.
The dual primary endpoints of CERVINO are overall response rate (ORR) and progression-free survival (PFS). Key secondary endpoints include overall survival (OS), depth of response, measurable residual disease (MRD) negativity, disease symptoms and physical functioning.
About Etentamig
Etentamig is an investigational, second-generation BCMA x CD3 bispecific antibody T-cell engager designed to combine meaningful anti-myeloma activity with a differentiated treatment experience for patients. Etentamig is composed of a low-affinity CD3 binding domain, designed to reduce cytokine release syndrome (CRS) and infections, a high-avidity bivalent BCMA-binding domain, and retained FcRn binding enabling monthly (Q4W) dosing after a single step-up dose. Clinical correlations of these structure-activity relationships have not been fully established.6
BCMA is highly expressed on the surface of malignant plasma cells in multiple myeloma, making it an ideal target for therapy. BCMA plays a crucial role in the survival of myeloma cells by promoting their growth and inhibiting their apoptosis (programmed cell death).5
Several clinical studies are evaluating the potential of etentamig across diverse patient populations and treatment settings. To learn more about AbbVie’s ongoing etentamig clinical trials, please visit clinicaltrials.gov.
(Press release, AbbVie, SEP 3, 2026, View Source [SID1234670580])