Launch Catch-Up — Results Announced October 26, 2026
Merck reported that its experimental medicine sacituzumab tirumotecan, or sac-TMT, improved survival against chemotherapy in a Phase 3 endometrial cancer trial.
The randomized study enrolled 776 patients with advanced or recurrent disease after platinum-based chemotherapy and anti-PD-1 or PD-L1 immunotherapy.
At a planned interim analysis, median overall survival was 19 months with sac-TMT and 12.1 months with chemotherapy, Merck said October 26. The estimated relative risk of death was 32% lower. That group-level estimate does not predict an individual patient’s outcome.
Grade 3 or higher treatment-related adverse events occurred in 54.4% of sac-TMT patients, compared with 41.4% receiving chemotherapy. Treatment-related deaths occurred in 0.8% in each group.
Merck said the FDA accepted its application for priority review and set June 15, 2027 as the target action date. Priority review is not approval. The drug remains investigational for this use in the United States, and the announcement does not establish access or suitability for individual patients.
Sources: Merck — October 26 trial results and regulatory announcement: https://www.merck.com/news/sacituzumab-tirumotecan-sac-tmt-reduced-the-risk-of-death-by-32-and-the-risk-of-disease-progression-or-death-by-41-compared-to-chemotherapy-in-certain-patients-with-advanced-or-recurrent-endometrial/