Iza-bren phase 3 trial met its primary endpoint in locally advanced/metastatic NSCLC

CAR-T Digest - August 2020

18 August 2026: Iza-bren phase 3 trial met its primary endpoint in locally advanced/metastatic NSCLC

Biokin announced that the phase 3 BL-B01D1-301 trial of Iza-bren met its pre-specified primary endpoint of progression-free survival in patients with locally advanced or metastatic NSCLC with EGFR-sensitizing mutations who had progressed following prior EGFR-TKI therapy, with a trend toward overall survival benefit also observed
The positive interim analysis marks the fourth phase 3 clinical study in which Iza-bren has met its primary endpoint and, according to the company, represents the first Phase 3 study worldwide of a bispecific ADC to meet its primary endpoint in NSCLC
The results address a significant unmet need in EGFR-mutant advanced NSCLC, where patients who progress following EGFR-TKI therapy have limited treatment options and require more effective targeted approaches beyond subsequent-line chemotherapy
Iza-bren is an EGFR×HER3 bispecific ADC designed to simultaneously target EGFR and HER3 on tumor cells, enabling targeted delivery of its cytotoxic payload following receptor-mediated internalization
Strategically, the positive phase 3 result further strengthens Iza-bren’s position as a leading bispecific ADC and expands its clinical validation beyond its currently approved indications in relapsed or metastatic nasopharyngeal carcinoma and esophageal squamous cell carcinoma, supporting its broader development across solid tumors