–  Etentamig is a second-generation BCMA-directed bispecific antibody T-cell engager with a clinical profile and dosing schedule that can potentially support treatment across a broad range of settings, including in community-based care
–  In the Phase 3 CERVINO study, etentamig achieved statistically significant improvements in overall response rate (ORR) and progression-free survival (PFS) versus investigator's choice of standard available therapies
–  Submission underscores AbbVie's ambition to advance a broad multiple myeloma portfolio that addresses disease complexity and supports patients' evolving care goals 

AbbVie  announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for etentamig, a second-generation BCMA x CD3 bispecific antibody T-cell engager administered intravenously for the treatment of adults with relapsed or refractory multiple myeloma.¹

BCMA-directed bispecific antibodies and CAR-T therapies have significantly changed the treatment landscape for people living with multiple myeloma.² However, their broader adoption may be limited by adverse events such as cytokine release syndrome, infections or neurotoxicity, as well as specialized administration and monitoring requirements.^2,3,4 Additionally, as disease relapses, treatment options in later lines of therapy become increasingly limited. Together, these factors highlight the need for additional therapies that may address the biology of the disease and help support effective treatment delivery across diverse care environments.^2,3,4

"Multiple myeloma is a chronic blood cancer that can reshape a person's life. 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, M.D., vice president and therapeutic area head, oncology, solid tumor and hematology, AbbVie. "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."

The submission is supported by results from the global, Phase 3, multicenter, randomized CERVINO study evaluating etentamig versus investigator's choice of standard available therapies (SAT) in patients with triple-class exposed relapsed or refractory multiple myeloma who had received at least two prior lines of therapy.⁵ Topline results were announced earlier this year.

• The findings indicated that etentamig achieved statistically significant improvements across the dual primary endpoints of overall response rate (74.0% vs. 45.7%) and progression-free survival (60% risk reduction) versus SAT.⁵
• The most common treatment-emergent adverse events (TEAEs) reported in the etentamig arm of the study (≥ 25%) included cytokine release syndrome (CRS), hypogammaglobulinemia, neutropenia and anemia.⁵
  • Discontinuations related to TEAEs were low for etentamig vs. SAT (3.6% vs. 14%).⁵
• With monthly dosing from initiation, etentamig demonstrated a potentially differentiated safety profile.⁵
  • Among patients receiving a single step-up dose, the incidence of CRS was low (28.3%), all being grade 1 (23.9%) or grade 2 (4.4%) and no grade 3 or higher events were reported.⁵ One patient experienced an immune effector cell-associated neurotoxicity syndrome (ICANS) event (grade 1).
  • Among all etentamig patients, grade 3/4 infections occurred in 27.7% versus 19.2% in patients receiving SAT.⁵ Importantly, grade 5 infections were observed less frequently in patients treated with etentamig (1.5%) versus SAT (3.1%).