What's Happening?
Kelun-Biotech presented positive Phase 3 data for trastuzumab botidotin at the 2025 ESMO Congress, showing significant improvement in progression-free survival (PFS) compared to T-DM1 in HER2-positive unresectable or metastatic breast cancer. The study
involved 365 patients who had received prior anti-HER2 therapy, with trastuzumab botidotin demonstrating a median PFS of 11.1 months versus 4.4 months for T-DM1. The drug also showed a higher overall response rate (ORR) and manageable safety profile, with ocular adverse events being the most common. These results suggest trastuzumab botidotin as a promising treatment option for pretreated HER2+ breast cancer patients.
Why It's Important?
The positive results from the Phase 3 trial of trastuzumab botidotin offer a new treatment option for patients with HER2-positive breast cancer, particularly those who have been pretreated with other anti-HER2 therapies. The drug's unique molecular design balances safety and efficacy, reducing the incidence of interstitial lung disease and hematologic toxicity. This advancement provides evidence-based support for personalized treatment approaches and updates to clinical practice guidelines, potentially improving patient outcomes and survival rates.
What's Next?
Kelun-Biotech is conducting a Phase 2 clinical study of trastuzumab botidotin in HER2+ unresectable or metastatic breast cancer patients who have previously received a topoisomerase inhibitor ADC. The company is also exploring the drug's application in other solid tumors, aiming to expand its therapeutic reach. Continued research and development could lead to broader approval and integration into treatment protocols for various cancer types.
