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AbbVie Submits Biologics License Application (BLA) for Etentamig to U.S. FDA for Adults Living With Relapsed/Refractory Multiple Myeloma

ABBV
  • AbbVie submitted a Biologics License Application (BLA) to the U.S. FDA for etentamig, a second-generation BCMA x CD3 bispecific antibody T-cell engager for relapsed or refractory multiple myeloma.
  • The Phase 3 CERVINO study showed etentamig achieved statistically significant improvements in overall response rate (74.0% vs. 45.7%) and progression-free survival (60% risk reduction) versus standard available therapies.
  • Etentamig utilizes a monthly dosing schedule (Q4W) following a single step-up dose, designed to support treatment in community-based care settings.
  • Treatment-emergent adverse events (≥25%) included cytokine release syndrome (CRS), hypogammaglobulinemia, neutropenia, and anemia, with a low discontinuation rate of 3.6% compared to 14% for standard therapies.
  • Among patients receiving a single step-up dose, CRS incidence was 28.3%, with all events being grade 1 or 2 and no grade 3 or higher events reported.
  • Grade 3/4 infections occurred in 27.7% of etentamig patients versus 19.2% for standard therapies, while fatal infections were less frequent (1.5% vs. 3.1%).
  • The drug targets BCMA, a protein highly expressed on malignant plasma cells, to promote growth inhibition and apoptosis of myeloma cells.
  • The CERVINO trial randomized 393 triple-class exposed patients to receive etentamig or investigator's choice of standard available therapies.