Randomized Phase III Study of Izalontamab Brengitecan

This document is a presentation of a randomized phase III study evaluating the efficacy and safety of izalontamab brengitecan (iza-bren) compared to physician's choice of chemotherapy in patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC). The study was conducted across 81 centers in China and involved 406 patients who had progressed after 1-2 prior lines of systemic therapy. The interim results indicated that iza-bren met both primary endpoints of progression-free survival (PFS) and overall survival (OS) at the pre-specified interim analysis. Median PFS was reported as 8.5 months for iza-bren versus 3.1 months for chemotherapy, with a 71% reduction in the risk of progression or death. Additionally, median OS was 15.9 months for iza-bren compared to 12.5 months for chemotherapy, indicating a 40% reduction in the risk of death. The findings support the potential of iza-bren as a new standard of care for this patient population.