Izalontamab brengitecan is an investigational EGFRxHER3 bispecific antibody-drug conjugate in oncology development by SystImmune and Bristol Myers Squibb outside China. U.S. FDA granted Breakthrough Therapy Designation in August 2025 for previously treated advanced EGFR-mutated NSCLC after EGFR TKI and platinum chemotherapy. The therapy remains investigational and under ongoing clinical evaluation.
Multiple phase 3 breast cancer trials reported significant findings in early 2026, including positive results for novel therapies across different subtypes. Key data includes progression-free survival benefits for palbociclib in HR-positive, HER2-positive advanced breast cancer and investigations of antibody-drug conjugates and combination therapies. Full trial findings are expected to be presented at upcoming medical meetings.
Bristol Myers Squibb and SystImmune reported that antibody-drug conjugate izalontamab brengitecan achieved statistically significant improvements in both progression-free and overall survival versus chemotherapy in a Phase III trial for triple-negative breast cancer.
Izalontamab brengitecan demonstrated statistically significant improvements in progression-free survival and overall survival compared to chemotherapy in patients with previously treated metastatic triple-negative breast cancer, marking the third Phase III success for the bispecific ADC.
