Merck announced positive results for sacituzumab tirumotecan in advanced or recurrent endometrial cancer

Merck announced positive results for P3 TroFuse-005 trial of sacituzumab tirumotecan (sac-TMT; TROP2 ADC) in advanced or recurrent endometrial cancer (a/r EC) who have progressed on platinum-based chemo and anti-PD-(L)1 immunotherapy.

The press release states that sac-TMT demonstrated statistically significant and clinically meaningful improvement in both OS and PFS compared to chemotherapy. 

• The TroFuse-005 regimen presents a direct competitive threat to ASCENT-GYN-01 as Sac-TMT is a key in-class competitor in EC, with a similar trial design
  • Global filings for TroFuse-005 are expected in 2026 with earliest potential US approval in Q3/Q4 2026 (utilizing FDA Commissioner’s National Priority Voucher) and EU approval in Q2 2027.

• At a pre-specified interim analysis, sac-TMT demonstrated a statistically significant and clinically meaningful improvement in its dual primary endpoints OS and PFS compared to TPC (consisting of doxorubicin or paclitaxel) for patients with a/r EC
  • The study also reached its key secondary endpoint of ORR.
  • Per the release, the safety profile was consistent with what has been observed in previously reported studies of sac-TMT, and no new safety signals were observed.
• Detailed results from this study are expected to be presented at an upcoming medical meeting (likely at ESMO 2026) and will clarify the magnitude of benefit over TPC and the safety and tolerability profile
  • Stomatitis and hematologic toxicities such as anaemia and neutropenia are known side effect associated with sac-TMT.

• Sac-TMT is the first TROP2 ADC to demonstrate statistically significant improvement in outcomes in a/r EC and this press release represents the first disclosure from the sac-TMT global Ph3 program which may support translation of Sac-TMT's China data into global studies
  • This disclosure also begins to validate Merck’s investment in the program which comprises of 17 ongoing global P3 trials across multiple tumor types including 6 trials in GYN cancers and 5 in NSCLC