What's Happening?
Sichuan Kelun-Biotech unveiled promising results from its Phase III OptiTROP-Breast02 trial at the European Society for Medical Oncology (ESMO) Congress 2025. The trial compared sacituzumab tirumotecan (sac-TMT), a TROP2-directed antibody-drug conjugate,
against physician's choice of chemotherapy in metastatic hormone receptor positive, HER2-negative breast cancer patients. Sac-TMT demonstrated significant improvement in median progression-free survival and overall survival compared to the control arm. The trial was conducted in China, and Sichuan Kelun has partnered with Merck & Co to commercialize sac-TMT outside China. Sac-TMT will compete with existing TROP2-targeted ADCs like Trodelvy and Datroway.
Why It's Important?
The positive trial results for sac-TMT could reshape the competitive landscape for TROP2-targeted therapies in breast cancer treatment. With Merck & Co's collaboration, sac-TMT has the potential to expand its market presence globally, challenging established treatments like Trodelvy and Datroway. The improved survival rates observed in the trial may offer new hope for patients with metastatic hormone receptor positive, HER2-negative breast cancer, a group with limited treatment options. The partnership with Merck & Co could accelerate sac-TMT's approval and availability in Western markets, potentially increasing competition and driving innovation in the ADC space.
What's Next?
To gain approval from the US FDA and European Medicines Agency, Sichuan Kelun and Merck & Co may need to conduct a global confirmatory Phase III trial to validate the findings. The companies are likely to focus on expanding sac-TMT's market presence and securing regulatory approvals in key markets. The analyst consensus forecast suggests sac-TMT could achieve significant sales by 2031, potentially surpassing competitors like Datroway and Trodelvy. The trial results may prompt further research into sac-TMT's efficacy and safety, influencing its clinical positioning in the breast cancer treatment landscape.
