Kelun-Biotech presents gynecologic cancer trial results at SGO

CHENGDU, China, April 14, 2026 /PRNewswire/ -- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech" or the "Company", 6990.HK) announced that results from both the ovarian cancer cohort and the cervical cancer cohort of Phase II study SKB264-II-06/MK-2870-002 of the TROP2 ADC sacituzumab tirumotecan (sac-TMT, also known as SKB264/MK-2870) (佳泰莱®), in combination with MSD's[1] anti-PD-1 monoclonal antibody pembrolizumab (KEYTRUDA®[2]), were selected for oral presentation at the 2026 Society of Gynecologic Oncology (SGO) Annual Meeting in San Juan, Puerto Rico. The data were presented by Professor Xiaohua Wu of Fudan University Shanghai Cancer Center.

Ovarian cancer

This presentation 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. The median follow-up was 22.2 months (data cutoff date: November 17, 2025).

The data showed that median progression-free survival (PFS) in the overall population was 20.9 months; median overall survival (OS) was not reached; and the 12-month OS rate was 92%. Additionally, the adverse events of sac-TMT in combination with pembrolizumab were manageable. The most common treatment-related adverse events (TRAEs) were anemia, stomatitis, and decreased neutrophil count. No deaths or discontinuations due to sac-TMT-related TRAEs was reported.

The 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 favorable safety profile, providing important evidence for further clinical exploration of this combination regimen in the ovarian cancer population.

Cervical cancer

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. Among the enrolled patients, 57% had prior bevacizumab therapy, and 51% had prior immunotherapy. The median follow-up was 24.7 months (data cutoff date: November 17, 2025).

The data showed that after treatment with sac-TMT in combination with pembrolizumab, the objective response rate (ORR) in the total population was 51% and 54% in IO-pretreated population. The median PFS was 7.3 months and the median OS reached 18.9 months in the total population. Furthermore, the safety profile of sac-TMT in combination with pembrolizumab was manageable, with no new safety signals identified and no deaths due to TRAEs.

The study results demonstrated promising and durable antitumor 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 robust data to support further clinical development.

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