AbbVie reports positive Phase 3 CERVINO results for etentamig in multiple myeloma

  • AbbVie reported positive topline results from the Phase 3 CERVINO trial of etentamig.
  • Etentamig produced a 74% response rate versus 45.7% with standard therapies.
  • The monitoring committee advised unblinding, while AbbVie will engage global regulators.

AbbVie reported positive topline results from the Phase 3 CERVINO trial evaluating etentamig in relapsed or refractory multiple myeloma. At a median follow-up of 11.4 months, 393 patients who had previously received a median of three treatment lines achieved a 74% objective response rate with etentamig, compared with 45.7% for standard available therapies. The investigational treatment also significantly improved progression-free survival across all evaluated subgroups. The 12-month overall survival rate was 87.9% with etentamig versus 72% with standard treatment, although the result had not crossed the prespecified efficacy boundary. Etentamig was administered using a single step-up dose followed by monthly treatment. Grade 3 or 4 infections occurred in 27.7% of patients versus 19.2% for standard therapy, while fatal grade 5 infections were reported in 1.5% and 3.1%, respectively. Cytokine release syndrome occurred in 28.3% of etentamig patients, with no grade 3 or higher cases, and one patient experienced mild neurotoxicity. Adverse-event discontinuations were 3.6% with etentamig versus 9.6% with standard therapies. The Independent Data Monitoring Committee advised unblinding the study, and AbbVie plans to engage global regulatory agencies on next steps. AbbVie shares were down 0.31% at $260.89 Thursday and were nearing their 52-week high of $267.47, according to Benzinga Pro data.

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