BMS Initiates First U.S. Phase 2/3 Trial of EGFR/HER3 ADC BL-B01D1 in Triple-Negative Breast Cancer

▎Armstrong

On April 15, 2025, Bristol-Myers Squibb registered a new EGFR/HER3 ADC drug, BL-B01D1 (Izalontamab Brengitecan), on the Clinicaltrials.gov website for head-to-head first-line treatment of locally recurrent, metastatic, or metastatic triple-negative breast cancer patients who are not suitable for PD-1. The development code is IZABRIGHT-Breast01.

This Phase 2/3 clinical trial plans to enroll 560 patients with advanced triple-negative breast cancer or ER low-expression/HER2-negative breast cancer, with preliminary completion expected by March 2028.

The primary endpoint of this Phase 2/3 clinical trial is PFS, with secondary endpoints including OS, ORR, etc.

Summary

BL-B01D1 is the world's first EGFR/HER3 ADC and also the core pipeline of Baili Tianheng. Currently, there are 9 Phase III clinical trials simultaneously advancing in China, with 5 indications included in the breakthrough therapy program. This time, Bristol-Myers Squibb has initiated triple-negative breast cancer, marking the advancement to the pivotal registrational clinical stage overseas. Baili Tianheng’s collaboration with Bristol-Myers Squibb retains half of the U.S. rights, which is expected to become another benchmark for innovative drug exports.