What's Happening?
Sichuan Kelun-Biotech presented findings from their Phase III OptiTROP-Breast02 trial at the 2025 European Society for Medical Oncology Congress. The trial compared sacituzumab tirumotecan, a TROP2-directed
antibody-drug conjugate, against standard chemotherapy in patients with metastatic hormone receptor-positive, HER2-negative breast cancer. The trial, conducted in China, showed that sacituzumab tirumotecan significantly improved median progression-free survival and showed a favorable trend in overall survival. The drug will compete with existing TROP2-targeted ADCs like Gilead's Trodelvy and AstraZeneca's Datroway.
Why It's Important?
The positive results from the OptiTROP-Breast02 trial could position sacituzumab tirumotecan as a strong competitor in the TROP2-targeted ADC market, potentially impacting the treatment landscape for hormone receptor-positive, HER2-negative breast cancer. The partnership with Merck & Co for commercialization outside China could expand its market reach. The trial's success may lead to further clinical trials in the U.S. and Europe, potentially affecting the competitive dynamics in the ADC market.
What's Next?
To gain regulatory approval in the U.S. and Europe, Sichuan Kelun and Merck & Co may need to conduct a global confirmatory Phase III trial. The companies will likely focus on validating the trial's findings in diverse patient populations. The market forecast suggests significant sales potential for sacituzumab tirumotecan, which could challenge existing ADCs in the market.
