MSD’s TROP2-directed antibody-drug conjugate (ADC), sac-TMT, has shown benefit in both overall survival (OS) and progression-free survival (PFS) in a Phase III trial in patients with endometrial cancer.
In the TroFuse-005 trial (NCT06132958), sacituzumab tirumotecan (sac-TMT) demonstrated a statistically significant and clinically meaningful improvement in OS and PFS compared to treatment of the physician’s choice (TPC, consisting of doxorubicin or paclitaxel) for patients with endometrial cancer who have previously received platinum-based chemotherapy and anti-PD-1/L1 immunotherapy either together or separately.
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The study also reached its key secondary endpoint of objective response rate. The trial enrolled 776 patients who were randomised to receive either sac-TMT or TPC.
Dr Domenica Lorusso, the study’s global lead investigator and professor of Obstetrics and Gynecology at Humanitas University and Humanitas San Pio X, Milan, said: “These results show sac-TMT may be able to address a critical unmet need for certain patients with advanced endometrial cancer, one of the only cancers increasing in both incidence and mortality worldwide. Despite recent advances, patients whose disease progresses following treatment with platinum and immunotherapy are urgently in need of new options, and these findings show for the first time that a TROP2 ADC may be an effective option in this setting.”
The safety profile was consistent with what has been observed in previously reported studies of sac-TMT, with no new safety signals observed.
These data will be presented at an upcoming medical meeting and discussed with regulatory authorities worldwide.
MSD said that TroFuse-005 is the first global Phase III trial to demonstrate statistically significant improvement in both OS and PFS compared to chemotherapy for these patients and the first and only ADC to do so for patients with endometrial cancer in this setting.
MSD’s TroFuse clinical development programme for sac-TMT consists of 17 ongoing global Phase III trials across multiple tumour types, including 10 Phase III trials in women’s cancers.
Sac-TMT, which is being developed in collaboration with China-based Kelun-Biotech, acts by targeting the trophoblast cell surface antigen-2 (TROP2) protein, which is widely expressed across a variety of solid tumours and is often associated with poor patient prognosis. The drug is already approved in China in multiple cancer indications.
A previous Phase III trial of the drug in non-small cell lung cancer (NSCLC) also showed success; however, this was specifically run in Chinese patients by Kelun. Biswajit Podder, oncology and haematology analyst at GlobalData, stated that more data is needed from MSD, which is currently running late-stage clinical trials involving the drug worldwide.
Podder stated: “For sac-TMT plus Keytruda to become a true worldwide standard, we will need to see data from the MSD-led global Phase III programmes that test this combination in populations more representative of wide practice and ideally against chemo immunotherapy comparators.”
