FDA Receives BLA for Etentamig in Relapsed/Refractory Multiple Myeloma

A biologics license application (BLA) for etentamig (ABBV-383) has been submitted to the FDA for the treatment of adults with relapsed or refractory multiple myeloma (relapsed/refractory multiple myeloma), according to a press release from the developer, AbbVie.¹

Etentamig is an investigational, second-generation BCMA/CD3 bispecific antibody T-cell engager administered intravenously. The submission is supported by results from the global phase 3 CERVINO trial (NCT06158841), in which the agent significantly improved overall response rate (ORR) and progression-free survival (PFS) vs investigator’s choice of standard available therapies (SAT).

What data supported the submission?

In the phase 3 CERVINO trial, etentamig met both dual primary end points, achieving a statistically significant improvement in ORR (74.0% vs 45.7%) and a 60% reduction in the risk of disease progression or death (HR, 0.40; 95% CI, 0.29-0.54; P <.0001) compared with SAT in patients with triple-class exposed relapsed/refractory multiple myeloma who had received at least 2 prior lines of therapy.^1,2 The PFS benefit was observed across all prespecified subgroups, including by age, cytogenetic risk, number of prior lines of therapy, and drug-class refractory status. Topline results from CERVINO were first announced earlier in 2026, and full results were presented at the 23rd Annual International Myeloma Society (IMS) Meeting & Exposition.

What was the safety profile?

The most common treatment-emergent adverse events (TEAEs) reported in at least 25% of patients in the etentamig arm were cytokine release syndrome (CRS), hypogammaglobulinemia, neutropenia, and anemia. Discontinuations related to TEAEs were low with etentamig compared with SAT (3.6% vs 14%). Among patients who received a single step-up dose, the incidence of CRS was 28.3%, with all events being grade 1 (23.9%) or grade 2 (4.4%) and no grade 3 or higher events reported. One patient experienced a grade 1 immune effector cell–associated neurotoxicity syndrome (ICANS) event. Among all etentamig-treated patients, grade 3/4 infections occurred in 27.7% vs 19.2% with SAT, while grade 5 infections were observed less frequently with etentamig (1.5% vs 3.1%).

“Patients deserve therapeutic options that are not only effective, but also support the realities of when, where and how they receive treatment,” said Daejin Abidoye, MD, vice president and therapeutic area head of oncology, solid tumor, and hematology at AbbVie, in the news release.¹ “This milestone brings us a step closer to potentially delivering a novel, patient-centered treatment option with a manageable safety profile and the convenience of a monthly dosing schedule that can help meet the needs of people living with multiple myeloma wherever they receive care.”

What was the CERVINO trial design?

CERVINO is a global, multicenter, randomized, open-label phase 3 study evaluating etentamig vs investigator’s choice of SAT in triple-class exposed patients with relapsed/refractory multiple myeloma who had received at least 2 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody. A total of 393 patients were randomly assigned 1:1 to receive etentamig or SAT, which included carfilzomib (Kyprolis) plus dexamethasone; elotuzumab (Empliciti) plus pomalidomide (Pomalyst) and dexamethasone; or selinexor (Xpovio) plus bortezomib (Velcade) and dexamethasone. Etentamig was administered using an optimized dosing strategy incorporating a single step-up dose followed by monthly (every-4-weeks) dosing from initiation.

The dual primary end points were ORR and PFS. Key secondary end points included overall survival, depth of response, measurable residual disease negativity, disease symptoms, and physical functioning.

What distinguishes etentamig?

Etentamig is a second-generation BCMA/CD3 bispecific antibody T-cell engager composed of a low-affinity CD3-binding domain designed to reduce CRS and infections, a high-affinity bivalent BCMA-binding domain, and retained neonatal Fc receptor binding that enables every-4-weeks dosing after a single step-up dose. According to the developers, the agent’s clinical profile and dosing schedule can potentially support treatment across a broad range of settings, including community-based care, where broader adoption of BCMA-directed bispecific antibodies and CAR T-cell therapies has been limited by AEs and specialized administration and monitoring requirements. Etentamig is being evaluated across multiple patient populations and treatment settings in an ongoing clinical program.

References

1. AbbVie submits biologics license application (BLA) for etentamig to U.S. FDA for adults living with relapsed/refractory multiple myeloma. News release. AbbVie. October 27, 2026. Accessed October 27, 2026. https://tinyurl.com/4we3d3rj
2. Voorhees P, Mateos MV, Costa L, et al. CERVINO: phase 3 results of etentamig vs investigator’s choice of standard available therapies in patients with triple-class exposed relapsed or refractory multiple myeloma (RRMM). Presented at: 23rd International Myeloma Society Annual Meeting; September 23-26, 2026; Glasgow, Scotland. Abstract LBA-01.