Major Advance in Endometrial Cancer Treatment

An international clinical trial involving the Catalan Institute of Oncology (ICO) in L'Hospitalet and Girona has shown that a new drug, sacituzumab tirumotecan (sac-TMT), significantly improves survival in patients with advanced or recurrent endometrial cancer who have stopped responding to standard therapies. The phase 3 TroFuse-005/ENGOT-en23/GOG-3095 trial, presented at the European Society for Medical Oncology (ESMO) Congress 2026 and published in The Lancet, included 776 patients across nearly 30 countries. All had previously received platinum-based chemotherapy and immunotherapy, leaving them with limited treatment options. At a median follow-up of 14.0 months, patients receiving sac-TMT had a median progression-free survival of 7.2 months, compared to 3.9 months for those on standard chemotherapy. This represents a 41% reduction in the risk of disease progression or death.

Improved Overall Survival and Tolerability

Median overall survival was 19.0 months in the sac-TMT group, versus 12.1 months in the control group, a 32% reduction in the risk of death. The drug also achieved a confirmed objective response rate of 35.1%, more than double the 17.3% seen with standard treatment. Sac-TMT is an antibody-drug conjugate that targets TROP2, a protein overexpressed in over 90% of endometrial cancers. It delivers chemotherapy directly to cancer cells, reducing damage to healthy tissue. Dr Marta Gil, an oncologist at ICO L'Hospitalet, said:

“In recent years, we have incorporated immunotherapy, which has represented a significant advance. However, after chemotherapy and immunotherapy, we were left without effective tools. This study is the first to achieve a very significant improvement in patient survival.”

Dr Beatriz Pardo, also from ICO L'Hospitalet, noted that the drug’s side effect profile differs from conventional chemotherapy, allowing for longer, more sustainable treatment.

Regulatory Review Underway

Based on these results, the U.S. Food and Drug Administration (FDA) has accepted for priority review a biologics license application for sac-TMT. A decision is expected by 15 June 2027. The trial marks the first global phase 3 study to show statistically significant improvement in both progression-free and overall survival in this patient group. The findings offer new hope for a population with historically poor prognosis and limited options.

Sources: LHDigital (L'Hospitalet), onclive.com, SMC Spain, merck.com.