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# AbbVie Announces Positive Etentamig Data in Multiple Myeloma
- URL: https://www.fdaweb.com/abbvie-announces-positive-etentamig-data-in-multiple-myeloma/
- Published: 2026-09-03T12:00:00.000Z
- Updated: 2026-09-14T12:05:17.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161733

AbbVie is reporting “positive topline results” from the Phase 3 CERVINO study evaluating etentamig, an investigational BCMA x CD3 bispecific T-cell engager, versus standard available therapies (SAT) in patients with triple-class exposed (proteasome inhibitor, immunomodulatory drug and anti-CD38 monoclonal antibody) relapsed/refractory multiple myeloma (RRMM).

CERVINO met its dual primary endpoints of objective response rate (ORR) and progression-free survival (PFS). According to the company, at the median follow-up of 11.4 months, etentamig demonstrated:

- Significantly higher ORR with etentamig vs. SAT (74.0% vs. 45.7%)
- Significantly improved PFS with etentamig vs. SAT
- 12-month overall survival was 87.9% for etentamig vs. 72.0% for SAT
- A “potentially differentiated safety profile. Grade 3/4 infections occurred in 27.7% and 19.2% of patients receiving etentamig and SAT, respectively. Fewer grade 5 infections occurred with etentamig (1.5%) vs. SAT (3.1%).”

AbbVie notes this was the “first planned efficacy interim analysis of the CERVINO study and, based on the significant benefit, the Independent Data Monitoring Committee (IDMC) recommended unblinding the study.”

It says that while BCMA-directed bispecific antibodies and CAR-T therapies have transformed multiple myeloma treatment, “their adoption remains limited by adverse events such as CRS \[cytokine release syndrome\], neurotoxicity and infections, as well as the need for specialized monitoring and treatment infrastructure.”

AbbVie plans to discuss the results with global regulatory authorities to determine next steps for etentamig.