Etentamig Demonstrates Superior Efficacy Over SOC in Relapsed/Refractory Myeloma
核心洞察
Etentamig, a BCMA (搜索)/CD3 (搜索) bispecific antibody, met both co-primary end points of the phase 3 CERVINO trial in triple-class exposed relapsed/refractory multiple myeloma (搜索).
Objective response rate was 74.0% with etentamig versus 45.7% with investigator's choice standard available therapies, with median PFS not reached versus 6.2 months.
Overall survival favored etentamig with a 52% reduction in risk of death, though the prespecified efficacy boundary was not crossed at data cutoff.
Etentamig, a BCMA (搜索)/CD3 (搜索) bispecific antibody, met both co-primary end points of the registrational phase 3 CERVINO trial (NCT06158841) in patients with triple-class exposed relapsed/refractory multiple myeloma (搜索), according to data presented at the 23rd Annual International Myeloma Society Meeting & Exposition. Among 393 randomly assigned patients at a median follow-up of 11.4 months, etentamig produced an objective response rate of 74.0% versus 45.7% with investigator's choice of standard available therapies (SAT), a difference of 28.3% (95% CI, 18.5%-37.5%; P < .0001). Responses were deeper with etentamig, with very good partial response or better in 63% versus 20% of patients and complete response or better in 40% versus 7%.
Median progression-free survival was not reached with etentamig versus 6.2 months with SAT (HR, 0.40; 95% CI, 0.29-0.54; P < .0001), and 12-month PFS rates were 62.1% versus 28.4%. The PFS benefit held across all prespecified subgroups, including age, cytogenetic risk, prior lines of therapy and drug-class refractory status. Median duration of response was not reached versus 10.2 months. In the key secondary overall survival analysis, etentamig reduced the risk of death from any cause by 52% (HR, 0.48; 95% CI, 0.29-0.77; P = .0012), although the prespecified efficacy boundary for OS was not crossed at the data cutoff; 12-month OS rates were 87.9% versus 72.0%.
Etentamig was given at 60 mg every 4 weeks after a single step-up dose, with outpatient initiation allowed. Among 113 patients treated with the single step-up dose, cytokine release syndrome occurred in 28.3% and was predominantly grade 1, with grade 2 events in 4.4% and no grade 3 or higher events; the CRS rate across all etentamig-treated patients before the single step-up dose was 39.5%. No CRS occurred among 22 patients who received prophylactic tocilizumab, and one grade 1 case of ICANS was reported. Grade 3/4 infections occurred in 27.7% of etentamig-treated patients versus 19.2% with SAT, and adverse events led to discontinuation in 3.6% versus 14.0%. CERVINO enrolled patients with at least 2 prior lines of therapy who were triple-class exposed to a proteasome inhibitor, an immunomodulatory drug and an anti-CD38 monoclonal antibody, with no prior BCMA (搜索) exposure.