Byondis Touts Promising Phase 3 Results for Antibody Drug Conjugate in HER2-Positive Breast Cancer

Byondis, a Dutch biopharma company focused on oncology drugs, reported that its late-stage trial evaluating its antibody-drug conjugate candidate for HER2-positive breast cancer met its primary endpoint, a development that’s given it confidence to file for FDA approval by the end of the year.

The phase 3 trial of Byondis’ SYD985, a combination of Herceptin (trastuzumab) and the investigational drug duocarmazine, successfully met its primary endpoint of progression-free survival, according to the company.

Byondis said that its candidate showed a statistically significant improvement over standard treatment in patients with pretreated HER2-positive unresectable locally advanced or metastatic breast cancer.

The company did not disclose any data but vowed to publish detailed findings at upcoming scientific conferences.