Biologics

Merck’s Sac-TMT BLA Gets Priority Review in Endometrial Cancer

FDA has accepted for priority review a Merck BLA for sacituzumab tirumotecan (sac-TMT), an investigational TROP2-directed antibody-drug conjugate (ADC), for adults with endometrial cancer previously treated with platinum-based chemotherapy and a PD-1 or PD-L1 inhibitor, administered separately or in combination. The agency has set a 6/15/2027 user fee review action target date.Merck says it hopes to secure approval ahead of that deadline.

The application is based on data from the Phase 3 TroFuse-005 trial, which demonstrated statistically significant improvements in overall survival (OS) and progression-free survival (PFS) compared with physician’s choice of chemotherapy in patients with advanced or recurrent endometrial cancer. At a prespecified interim analysis, Merck says sac-TMT reduced the risk of death by 32% compared with chemotherapy. Median OS was 19.0 months with sac-TMT versus 12.1 months with chemotherapy.

The investigational treatment also reduced the risk of disease progression or death by 41%, according to Merck, adding that median PFS was 7.2 months for those on the therapy versus 3.9 months for those on chemo.

Merck says the safety profile was consistent with previous sac-TMT studies, with no new safety signals identified. Grade 3 or higher treatment-related adverse events occurred in 54.4% of sac-TMT recipients compared with 41.4% of chemotherapy recipients. The most common severe adverse events with sac-TMT were anemia (23.7%), neutropenia (20.1%) and oral mucositis/stomatitis (9.9%).

Treatment-related adverse events led to discontinuation in 3.1% of patients receiving sac-TMT versus 4.9% receiving chemotherapy, it says. Treatment-related deaths occurred in 0.8% of patients in each arm.

Merck said TroFuse-005 is the first global Phase 3 trial of a TROP2-directed ADC to demonstrate statistically significant improvements in both OS and PFS over chemotherapy in this patient population.

The findings were presented at the European Society for Medical Oncology Congress 2026 and published simultaneously in The Lancet.

Sac-TMT is being developed by Merck in collaboration with Kelun-Biotech. The companies are evaluating the treatment in a broad clinical development program that includes 18 ongoing global Phase 3 trials across multiple cancer types.

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Quality Procedures, Investigations Top FDA Drug Citations

Risk Management, Corrective Actions Lead Device Inspection Findings

FDA Posts 172 Additional Inspection Records

Brand, Generic Drug Groups Seek Changes to Approval Pathways Guide