CSPC PHARMA(01093): Phase I clinical study data of SYS6002 monotherapy for the treatment of advanced cervical cancer was presented as a rapid oral presentation at IGCS2026

CSPC PHARMA (01093) announced that the Group has presented the data from the Phase I clinical study of SYS6002 monotherapy for the treatment of advanced cervical cancer (the Study) as a rapid oral presentation at the 2026 International Gynecologic Cancer Society Global Annual Meeting (IGCS 2026). The Study is a nationwide multicenter Phase I clinical trial designed to evaluate the safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy of SYS6002 in patients with advanced solid tumors. At this conference, the Group presented the results of SYS6002 monotherapy in previously treated advanced cervical cancer. As of May 8, 2026, a total of 82 patients were enrolled in the Study and assigned to two dose groups, including 39 patients in the 2.4 mg/kg once every 2 weeks dose group and 43 patients in the 3.6 mg/kg once every 3 weeks dose group, with a median follow-up time of 16.1 months. The relevant safety and efficacy data are as follows: In terms of safety, the safety profiles of the above two dose groups were generally manageable, with treatment-related adverse events mostly of Grade 12. Among them, ocular-related adverse events were the most common, but no Grade 3 or above events occurred, and no patient discontinued treatment due to such events. The incidence of interstitial lung disease and non-infectious pneumonia was low (2.4%). The incidence and grade of treatment-related rash were both low (any grade: 20.7%; Grade 3 or above: 1.2%), and no Stevens-Johnson syndrome or toxic epidermal necrolysis occurred. The incidence and grade of peripheral neuropathy were also low (12.2%; all Grade 12). In addition, no treatment-related adverse events leading to death occurred. In terms of efficacy, both dosing regimens showed preliminary efficacy in the study population. The confirmed objective response rate was 35.9% in the 2.4 mg/kg once every 2 weeks dose group and 28.6% in the 3.6 mg/kg once every 3 weeks dose group. The median duration of response for patients achieving confirmed response in the two groups was 8.2 months and 10.3 months, respectively; the median progression-free survival was 4.1 months and 4.3 months, respectively; and the median overall survival was 15.1 months and 11.5 months, respectively. Currently, the study of the SYS6002 2.4 mg/kg once every 2 weeks regimen for immunotherapy-treated advanced cervical cancer has entered a Phase III clinical trial (NCT07230626).