Chinese pharmaceutical company Sichuan Kelun-Biotech Biopharmaceutical Co Ltd (HK:6990) announced on Monday that results from both the ovarian cancer cohort and the cervical cancer cohort of a Phase II study of the TROP2 ADC sacituzumab tirumotecan (sac-TMT, also known as SKB264/MK-2870), in combination with MSD's anti-PD-1 monoclonal antibody pembrolizumab (KEYTRUDA), were selected for oral presentation at the 2026 Society of Gynecologic Oncology (SGO) Annual Meeting in San Juan, Puerto Rico.
A presentation by Professor Xiaohua Wu of Fudan University Shanghai Cancer Center reported, for the first time, important data on sac-TMT as maintenance treatment in breast cancer susceptibility gene (BRCA) wild-type, second-line platinum-sensitive recurrent ovarian cancer. Among the 40 patients enrolled in the ovarian cancer cohort, 27 received sac-TMT 4 mg/kg every other week (Q2W) in combination with pembrolizumab, and 13 received sac-TMT 5 mg/kg Q2W in combination with pembrolizumab. Among the enrolled patients, 70% had prior bevacizumab therapy, and 58% had prior PARP inhibitor therapy.
Study results showed that sac-TMT in combination with pembrolizumab as maintenance therapy for platinum-sensitive recurrent ovarian cancer demonstrated positive efficacy signals and a favourable safety profile, providing evidence for further clinical exploration of this combination regimen in the ovarian cancer population.
A total of 68 patients with previously treated second-line or third-line recurrent or metastatic cervical cancer were enrolled in the cervical cancer cohort to receive sac-TMT at doses of 3 mg/kg, 4 mg/kg, or 5 mg/kg Q2W in combination with pembrolizumab.
Results demonstrated promising and durable anti-tumour activity with a manageable safety profile in patients with pre-treated second-line or third-line recurrent or metastatic cervical cancer receiving sac-TMT in combination with pembrolizumab, providing data to support further clinical development.
In May 2022, Kelun-Biotech licensed the exclusive rights to US pharmaceutical company Merck & Co Inc (NYSE:MRK), known as MSD outside the US and Canada, to develop, use, manufacture and commercialise sac-TMT in all territories outside of Greater China (which includes Mainland China, Hong Kong, Macao and Taiwan).
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