Etentamig in triple-class exposed RRMM: Primary results from the phase III CERVINO study

Primary results from the randomized phase III CERVINO (NCT06158841) study, evaluating etentamig vs investigator’s choice of standard available therapies (SAT) in patients with triple-class-exposed relapsed/refractory multiple myeloma (RRMM) who had received ≥2 prior lines of therapy (LoT) and had no prior exposure to B-cell maturation antigen (BCMA)-directed therapy, were presented by Peter Voorhees at the 23rd International Myeloma Society (IMS) Annual Meeting and Exposition, September 23–26, 2026, Glasgow, UK. The primary endpoints were overall response rate (ORR) and progression-free survival (PFS).

Key data: At a median follow-up of 11.4 months, ORR was 74.0% with etentamig (n = 196) vs 45.7% with SAT (n = 197; p < 0.0001), with ≥CR rates of 40% vs 7%, respectively. Median PFS was not reached (NR) with etentamig vs 6.2 months with SAT; 12-month PFS rates were 62.1% vs 28.4%, respectively (HR, 0.40; 95% confidence interval [CI], 0.29–0.54; p < 0.0001). Median overall survival (OS) was NR in both arms; 12-month OS rates were 87.9% with etentamig vs 72.0% with SAT (HR, 0.48; 95% CI, 0.29–0.77; p = 0.0012). Grade 3/4 infections occurred in 27.7% of patients receiving etentamig vs 19.2% receiving SAT, while adverse event (AE)-related treatment discontinuations occurred in 3.6% vs 14.0%, respectively. Among patients receiving a single step-up dose of etentamig (n = 113), cytokine release syndrome (CRS) occurred in 28.3% (Grade 1, 23.9%; Grade 2, 4.4%; no Grade ≥3); immune effector cell-associated neurotoxicity syndrome (ICANS) occurred in 0.9% (all Grade 1).

Key learning: In this phase III study, etentamig was associated with a higher ORR and longer PFS than SAT, corresponding to a 60% reduction in the risk of disease progression or death in BCMA-naïve patients with triple-class exposed RRMM who had received ≥2 prior LoT.