What's Happening?
Kelun-Biotech has announced positive results from a Phase 3 study of trastuzumab botidotin, a HER2-directed antibody-drug conjugate (ADC), at the 2025 European Society for Medical Oncology (ESMO) Congress.
The study compared trastuzumab botidotin to trastuzumab emtansine (T-DM1) in patients with HER2-positive unresectable or metastatic breast cancer. Results showed that trastuzumab botidotin significantly improved progression-free survival (PFS) and overall response rate (ORR) compared to T-DM1. The study involved 365 patients, and the median PFS for trastuzumab botidotin was 11.1 months versus 4.4 months for T-DM1.
Why It's Important?
The study's findings are crucial as they suggest trastuzumab botidotin could become a new treatment option for patients with HER2-positive breast cancer who have previously received anti-HER2 therapies. The improved PFS and ORR indicate that trastuzumab botidotin may offer better efficacy than existing treatments, potentially leading to changes in clinical practice guidelines. The manageable safety profile further supports its use in a clinical setting, providing hope for improved patient outcomes.
What's Next?
Kelun-Biotech plans to continue the development of trastuzumab botidotin, with ongoing Phase 2 studies targeting HER2-positive breast cancer patients who have previously received topoisomerase inhibitor ADCs. The company aims to expand its research to further validate the efficacy and safety of trastuzumab botidotin, potentially leading to broader clinical adoption and regulatory approvals.
