Key insights
- Merck's investigational drug, sacituzumab tirumotecan (sac-TMT), demonstrated a 32% reduction in the risk of death and a 41% reduction in the risk of disease progression or death in patients with advanced or recurrent endometrial cancer. The drug, developed with Kelun-Biotech, showed significant improvements in overall and progression-free survival compared to chemotherapy. The U.S. FDA has accepted a priority review for sac-TMT, with a target action date of June 15, 2027. These positive trial results are a
Merck (MRK) announced results from its pivotal Phase 3 TroFuse-005 trial showing that sacituzumab tirumotecan (sac-TMT), an investigational TROP2-directed antibody-drug conjugate (ADC) developed with Kelun-Biotech, reduced the risk of death by 32% and the risk of disease progression or death by 41% compared to chemotherapy in patients with advanced or recurrent endometrial cancer who had previously received platinum-based chemotherapy and anti-PD-1/L1 immunotherapy.
At a pre-specified interim analysis with a median follow-up of 14.0 months, sac-TMT extended median overall survival (OS) by 6.9 months compared to treatment of physician’s choice (19.0 months vs. 12.1 months). Median progression-free survival (PFS) was extended by 3.3 months (7.2 months vs. 3.9 months). The objective response rate was 35.1% in the sac-TMT arm versus 17.3% in the chemotherapy arm, with a median duration of response of 11.1 months versus 6.9 months, respectively.
The trial enrolled 776 patients randomized to receive sac-TMT or chemotherapy consisting of doxorubicin or paclitaxel. Grade 3 or higher treatment-related adverse events occurred in 54.4% of sac-TMT patients and 41.4% of chemotherapy patients. The most common Grade 3 or higher events with sac-TMT were anemia (23.7%), neutropenia (20.1%), and oral mucositis/stomatitis (9.9%). Treatment discontinuation rates were 3.1% and 4.9%, respectively.
The U.S. Food and Drug Administration has accepted for priority review a Biologics License Application for sac-TMT in this patient population, with a PDUFA target action date of June 15, 2027.
The results were presented at the European Society for Medical Oncology Congress 2026 and published simultaneously in The Lancet. Sac-TMT was developed by Kelun-Biotech (6990.HK), a subsidiary of Kelun Pharmaceutical (002422.SZ), which has granted Merck exclusive rights to develop and commercialize the drug outside of Greater China.
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