AbbVie Etentamig Hits 74 Percent ORR in Phase 3 CERVINO Myeloma Trial

What changed

AbbVie announced on 3 September 2026 that the Phase 3 CERVINO trial met both primary endpoints for etentamig, an investigational BCMA x CD3 bispecific T cell engager, versus standard available therapies in triple class exposed relapsed or refractory multiple myeloma.

Topline results reported objective response rate of 74.0 percent for etentamig versus 45.7 percent for standard therapies (P less than 0.0001). Progression free survival improved with hazard ratio 0.40 (P less than 0.0001), a 60 percent reduction in risk of progression or death. The trial enrolled 393 patients with median three prior lines of therapy and median follow up of 11.4 months.

Etentamig is investigational and not FDA approved. Full data are scheduled for a plenary session at the 23rd International Myeloma Society Annual Meeting on 25 September 2026 in Glasgow.

Why it matters

Triple class exposed myeloma patients exhaust familiar regimens quickly. A Phase 3 win on both ORR and PFS with monthly dosing after a single step up dose could shift treatment toward outpatient community settings if the full dataset confirms tolerability.

AbbVie reported cytokine release syndrome in 28.3 percent of patients during step up dosing, predominantly grade 1, with no grade 3 or higher CRS events in the topline release. Payers and hospital pharmacy teams will still need the plenary safety tables before modeling site of care.

Who is affected

Hematology oncologists treating relapsed myeloma, hospital outpatient infusion centers, AbbVie competitors in BCMA bispecifics, and investors comparing etentamig against approved T cell engagers on dosing convenience.

What to do next

Hold formulary and pathway updates until the 25 September plenary dataset publishes. Model budget impact using monthly Q4W infusion assumptions versus more frequent competitor schedules only after reviewing full adverse event tables.

What to watch

IMS plenary presentation on 25 September 2026, any FDA filing timeline AbbVie discloses after regulator meetings, and subgroup PFS in high risk cytogenetics once full slides release.

Sources

1. Primary. AbbVie, CERVINO Phase 3 topline press release (3 September 2026). ORR, PFS HR, trial size, CRS rates, plenary date.
2. Secondary. PRNewswire, AbbVie CERVINO announcement (3 September 2026). Confirms dual primary endpoint success and NCT06158841 registry reference.