Etentamig multiple myeloma treatment has cleared a major clinical milestone. AbbVie (NYSE: ABBV) announced on Sept. 3, 2026, that its Phase 3 CERVINO trial met both primary endpoints, showing that the investigational therapy significantly improved response rates and slowed disease progression compared with standard available therapies (SAT) in patients with relapsed/refractory multiple myeloma (RRMM). The study evaluated etentamig, an investigational BCMA x CD3 bispecific T-cell engager, in a triple-class exposed population that had already received a proteasome inhibitor, an immunomodulatory drug and an anti-CD38 monoclonal antibody.
At the data cutoff, the etentamig multiple myeloma study included 393 patients who had received a median of three prior lines of therapy. At a median follow-up of 11.4 months, etentamig achieved an objective response rate (ORR) of 74.0% versus 45.7% for SAT, a statistically significant difference (P<0.0001). Progression-free survival (PFS) also favored etentamig, with a hazard ratio of 0.40, representing a 60% reduction in the risk of disease progression or death versus comparator regimens.
Twelve-month overall survival (OS) data further supported the etentamig multiple myeloma profile, reaching 87.9% for patients on etentamig compared with 72.0% for those on SAT, a hazard ratio of 0.48. AbbVie noted that the prespecified efficacy boundary for OS had not yet been crossed at this data cutoff, and follow-up for survival outcomes is ongoing. The PFS benefit held consistently across all pre-specified patient subgroups evaluated in the analysis.
All figures cited here are drawn directly from AbbVie’s Sept. 3, 2026, corporate disclosure and are described by the company as topline results; full statistical detail, subgroup breakdowns and independent peer review are expected once the etentamig multiple myeloma data are presented at the International Myeloma Society meeting later this month. AbbVie’s release also carries standard forward-looking-statement language cautioning that actual outcomes, including any future regulatory decisions on etentamig, could differ from what current trial data suggest.
Phase 3 CERVINO Trial Design for Etentamig Multiple Myeloma Treatment
The etentamig multiple myeloma program is being evaluated through CERVINO (NCT06158841), a global, multicenter, randomized, open-label Phase 3 study. Patients with RRMM who had received at least two prior lines of therapy, including exposure to a proteasome inhibitor, an immunomodulatory drug and an anti-CD38 monoclonal antibody, were randomized 1:1 to receive etentamig once every four weeks (Q4W) or investigator’s choice of SAT.
Comparator regimens in the SAT arm included carfilzomib plus dexamethasone, elotuzumab plus pomalidomide and dexamethasone, or selinexor plus bortezomib and dexamethasone. Etentamig itself was administered using an optimized dosing strategy incorporating a single step-up dose followed by monthly dosing from initiation, a schedule AbbVie says is central to the drug’s differentiated profile.
This marked the first planned efficacy interim analysis of the CERVINO study. Based on the magnitude of benefit observed, the Independent Data Monitoring Committee recommended unblinding the trial. Full data from the etentamig multiple myeloma analysis will be presented in a plenary session at the 23rd International Myeloma Society Annual Meeting, held September 23-26, 2026, in Glasgow, Scotland.
Etentamig Multiple Myeloma Efficacy Results: Response Rate and Survival Data
Dr. Peter Voorhees, Chief of the Plasma Cell Disorders Division at Atrium Health Levine Cancer Institute and a CERVINO investigator, said etentamig “delivered clinically meaningful improvements in progression-free survival and response rates” in this heavily pretreated population. He noted that the manageable safety profile, combined with the drug’s dosing schedule, supports its role as a BCMA-targeted option for patients across a range of care settings.
The etentamig multiple myeloma data arrive as BCMA-directed bispecific antibodies and CAR-T therapies continue to reshape multiple myeloma care, though AbbVie and outside researchers note that adoption of existing options has been limited by cytokine release syndrome, neurotoxicity, infections and the need for specialized monitoring infrastructure. As disease relapses and treatment options narrow, AbbVie frames the CERVINO results as addressing a persistent unmet need for additional therapies deployable beyond specialized referral centers.
Consistency of the PFS benefit across pre-specified subgroups is a detail AbbVie is highlighting heavily, since it suggests the etentamig multiple myeloma treatment effect is not confined to a narrow slice of the trial population but extends across differing baseline disease characteristics.
Safety Profile of Etentamig Multiple Myeloma Therapy Shows Low CRS Rates
Safety data from the etentamig multiple myeloma trial point to a differentiated tolerability profile tied to its single step-up dose and monthly maintenance schedule. Grade 3/4 infections occurred in 27.7% of etentamig patients versus 19.2% of SAT patients, while fatal (grade 5) infections were less frequent with etentamig (1.5%) than SAT (3.1%). Among patients receiving the single step-up dose, cytokine release syndrome occurred in 28.3% of cases, predominantly low-grade (23.9% grade 1), with no grade 3 or higher CRS events reported.
Immune effector cell-associated neurotoxicity syndrome occurred in a single patient (0.9%), classified as grade 1, with no grade 2 or higher events. Treatment discontinuations related to adverse events were markedly lower with etentamig (3.6%) than with SAT (9.6%). AbbVie attributes this profile to etentamig’s molecular design: a low-affinity CD3-binding domain intended to reduce CRS and infection risk, paired with a high-avidity bivalent BCMA-binding domain and retained FcRn binding that enables the monthly dosing interval.
AbbVie’s oncology leadership frames the etentamig multiple myeloma safety data as central to expanding bispecific therapy beyond specialized transplant and CAR-T centers. Daejin Abidoye, M.D., vice president and therapeutic area head for oncology, solid tumor and hematology at AbbVie, said the CERVINO results demonstrate the value of designing therapies that address both the biology of multiple myeloma and the practical needs of patients and providers, reinforcing confidence in AbbVie’s broader multiple myeloma strategy.
