Merck’s experimental cancer drug sacituzumab tirumotecan helped patients with previously treated advanced or recurrent endometrial cancer live longer than standard chemotherapy in a global late-stage trial, the company reported Monday.
Patients receiving the drug, also called sac-TMT, had median overall survival of 19 months, compared with 12.1 months for those receiving chemotherapy. The result represented a 32% reduction in the risk of death over the study period, Merck said in its October 26 results announcement.
The Food and Drug Administration has accepted an application for priority review, with a target decision date of June 15, 2027. The treatment remains investigational for this use; priority review is not an approval.
The Phase 3 TroFuse-005 trial enrolled 776 patients whose cancer had already been treated with platinum-based chemotherapy and an immunotherapy targeting PD-1 or PD-L1. Participants were randomly assigned to sac-TMT or a physician’s choice of doxorubicin or paclitaxel.
Median time before cancer progression or death was 7.2 months with sac-TMT versus 3.9 months with chemotherapy, a 41% reduction in that risk. Tumor responses occurred in 35.1% of patients receiving sac-TMT, compared with 17.3% in the chemotherapy group.
The gains came with more severe treatment-related side effects. Grade 3 or higher events affected 54.4% of patients receiving sac-TMT and 41.4% receiving chemotherapy. Common serious events with sac-TMT included anemia, low levels of infection-fighting white blood cells, and inflammation in the mouth. Treatment-related adverse events led to three deaths in each group.
Sac-TMT is an antibody-drug conjugate designed to attach to the TROP2 protein on tumor cells and deliver a cancer-killing payload. Merck is developing it with Kelun-Biotech, which developed the therapy.
NYU Langone Health, whose researchers helped lead the study, said patients were enrolled at more than 200 cancer centers in 29 countries. Merck funded the research. The results are being presented at the European Society for Medical Oncology congress and published in The Lancet.
JBizNews Desk | Rahway, New Jersey
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