AbbVie多发性骨髓瘤候选药etentamig三期CERVINO达到ORR和PFS双主要终点

AbbVie ( ABBV ) on Thursday announced that etentamig, its experimental therapy for a type of blood cancer known as multiple myeloma, succeeded in a late-stage trial for a group of heavily pretreated patients. Citing topline data from its Phase 3 CERVINO study, the company said that the BCMA x CD3 bispecific T-cell engager met its dual primary endpoints related to objective response rate and progression-free survival. The trial was designed to evaluate etentamig versus standard available therapies ((SAT)) as a late-line option for patients with relapsed/refractory multiple myeloma who had undergone a median of three prior lines of therapy at the data cutoff. At a median follow-up of 11.4 months, patients on etentamig showed a statistically significant benefit in ORR and PFS, while data for 12-month overall survival didn’t meet the prespecified threshold at the data cutoff, AbbVie ( ABBV ) said. However, because of the significant beneficial effects seen, the Independent Data Monitoring Committee (IDMC) recommended unblinding the study, the company added. Regarding safety, patients on etentamig experienced a higher rate of Grade 3/4 infections (27.7%) than those on SAT (19.2%), and the rate of Grade 5 infections was lower in the etentamig group (1.5%) than in the SAT group (3.1%). The company plans to engage global regulators to discuss CERVINO results and determine next steps of the program.