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 Cancer
Key Highlights
- ➤Sac-TMT cut death risk 32%; median overall survival reached 19.0 months
- ➤Sac-TMT cut progression or death risk 41%; median PFS reached 7.2 months
- ➤Objective response rate doubled versus chemotherapy, reaching 35.1%
- ➤FDA accepted sac-TMT’s BLA for priority review; PDUFA date June 15, 2027
- ➤TroFuse-005 enrolled 776 patients in a global Phase 3 trial
Expert Statements
Domenica Lorusso, Global lead investigator; lead investigator for ENGOT; professor of Obstetrics and Gynecology at Humanitas University and Humanitas San Pio X, Milan
“Sac-TMT is the first TROP2 ADC to demonstrate an improvement in overall survival in advanced or recurrent endometrial cancer in this setting compared to chemotherapy in a global Phase 3 trial. In addition, TroFuse-005 found a higher response rate and longer duration of response among patients treated with sac-TMT compared to chemotherapy.”
Domenica Lorusso, Global lead investigator; lead investigator for ENGOT; professor of Obstetrics and Gynecology at Humanitas University and Humanitas San Pio X, Milan
“The incidence and mortality rates of endometrial cancer are increasing worldwide, and the results from TroFuse-005 have the potential to change the way we treat patients who have received prior platinum-based chemotherapy and anti-PD-1/L1 immunotherapy.”
Dean Y. Li, President, Merck Research Laboratories
“Sac-TMT demonstrated an improvement in overall survival of almost seven months for women with endometrial cancer who progress following treatment with platinum-based chemotherapy and anti-PD-1 therapy, a meaningful advancement for these women who face a median survival of less than a year with current therapies.”
Dean Y. Li, President, Merck Research Laboratories
“We believe sac-TMT, with its unique bifunctional linker, can become a cornerstone for the treatment of certain patients with advanced or recurrent endometrial cancer. Based on discussions with the U.S. FDA, the company is hopeful for an approval before the PDUFA date to bring sac-TMT to patients as quickly as possible.”
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 Cancer
TroFuse-005 is the first and only global Phase 3 study of a TROP2 ADC to demonstrate improved overall survival (OS) and progression-free survival (PFS) compared to chemotherapy in these patients who have received prior platinum-based chemotherapy and anti-PD-1/L1 immunotherapy
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