What's Happening?
Kelun-Biotech has presented positive Phase 3 data for its HER2-directed antibody-drug conjugate (ADC), trastuzumab botidotin, at the 2025 European Society for Medical Oncology Congress. The study compared
trastuzumab botidotin to trastuzumab emtansine (T-DM1) in patients with HER2-positive unresectable or metastatic breast cancer. The results showed a significant improvement in progression-free survival (PFS) with trastuzumab botidotin, which had a median PFS of 11.1 months compared to 4.4 months for T-DM1. The objective response rate was also higher at 76.9% versus 53.0%. The study highlighted the drug's manageable safety profile, with ocular adverse events being the most common.
Why It's Important?
The findings are crucial as they offer a new treatment option for patients with HER2-positive breast cancer, a group that often faces limited options after initial therapies. The improved PFS and objective response rate suggest that trastuzumab botidotin could become a preferred treatment, potentially improving survival rates and quality of life for patients. This development also underscores the importance of ADCs in cancer treatment, which combine targeted therapy with chemotherapy to enhance efficacy while minimizing side effects.
What's Next?
Kelun-Biotech plans to continue its research with an open, multi-center Phase 2 study of trastuzumab botidotin in patients who have previously received topoisomerase inhibitor ADCs. The company is also likely to seek regulatory approval based on these promising results, which could lead to the drug's availability in broader markets.
