Phase III Study of Izalontamab Brengitecan in ESCC

This document presents a technical report on a multicenter, randomized, open-label, phase III study evaluating the efficacy and safety of Izalontamab Brengitecan (Iza-bren) compared to chemotherapy in patients with recurrent or metastatic esophageal squamous cell carcinoma (ESCC). The study aimed to address the need for effective second-line treatments for advanced ESCC, particularly in patients who have progressed after first-line therapy. The report outlines the study design, including key eligibility criteria and treatment protocols, and details the primary endpoints of progression-free survival (PFS) and overall survival (OS). Interim results indicate that Iza-bren demonstrated statistically significant improvements in both PFS and OS compared to chemotherapy, with a manageable safety profile. The findings suggest that Iza-bren may serve as a new standard of care for ESCC in China, highlighting its potential role in improving patient outcomes in this challenging clinical setting.