Merck (NYSE: MRK) and Kelun-Biotech (HKEX: 6990) advance sac-TMT towards US endometrial-cancer review
Global survival data and FDA priority review give the ADC a separate regulatory opportunity from its lung-cancer programme.
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Sac-TMT improved overall survival in the global Phase 3 TroFuse-005 study of previously treated endometrial cancer. The study enrolled 776 patients whose prior treatment included platinum chemotherapy and PD-1 or PD-L1 therapy.
Median overall survival was 19 months with sac-TMT and 12.1 months with the comparator, corresponding to a 32% reduction in the hazard of death. Median progression-free survival was 7.2 months versus 3.9 months.
The FDA has accepted the application for priority review, with a target decision date of 15 June 2027. Priority review accelerates the assessment timetable; it does not predetermine approval.
For Merck and Kelun-Biotech, this is a distinct opportunity supported by global evidence and a defined regulatory process. Investors can now assess the programme against a concrete timetable, while recognising that the agency will review safety, manufacturing and the full clinical package. The survival finding is more consequential than an early response signal, but commercial access still depends on that review.
Source: Fierce Pharma TroFuse-005 and regulatory reporting, 26 October.