June 2026 SystImmune and Bristol Myers Squibb reported that izalontamab brengitecan, an EGFR×HER3 bispecific antibody-drug conjugate, demonstrated statistically significant improvements in overall survival and progression-free survival in Phase III studies involving triple-negative breast cancer and esophageal squamous-cell carcinoma. China’s Center for Drug Evaluation also accepted the New Drug Application for recurrent or metastatic esophageal squamous-cell carcinoma and placed it under priority review.
December 2025 Alphamab Oncology advanced JSKN016, its internally developed TROP2×HER3 bispecific antibody-drug conjugate, into Phase III clinical development for triple-negative breast cancer. The candidate is designed to bind both TROP2 and HER3, improving tumour recognition and targeted delivery of a topoisomerase-I inhibitor payload.
August 2025 The U.S. FDA granted Breakthrough Therapy Designation to SystImmune and Bristol Myers Squibb’s izalontamab brengitecan for patients with previously treated advanced EGFR-mutated non-small-cell lung cancer. The designation supported accelerated development of the bispecific ADC, which simultaneously targets EGFR and ERBB3/HER3.
May 2025 Daiichi Sankyo and Merck voluntarily withdrew the U.S. Biologics License Application for patritumab deruxtecan, a HER3-directed antibody-drug conjugate, for previously treated EGFR-mutated non-small-cell lung cancer. The companies continued evaluating data to identify patient populations and other indications that could potentially benefit from HER3-directed treatment.