Efficacy and safety of serplulimab plus nab-paclitaxel in previously treated patients with PD-L1-positive advanced cervical cancer: a phase II, single-arm study

This phase II, single-arm study investigated the efficacy and safety of serplulimab (a humanized anti-programmed death-1 antibody) plus nab-paclitaxel in previously treated patients with PD-L1-positive advanced cervical cancer. 21 patients received serplulimab 4.5 mg/kg and nab-paclitaxel 260 mg/m² every 3 weeks. The primary endpoints were safety and objective response rate (ORR). The IRRC-assessed ORR was 57.1% (95% CI 34.0-78.2%), with a median duration of response not reached. Median progression-free survival was 5.7 months (95% CI 3.0-NR), and median overall survival was 15.5 months (95% CI 10.5-NR). Eighty-one percent of patients experienced grade ≥3 treatment-emergent adverse events, with 33.3% experiencing grade ≥3 adverse drug reactions. Immune-related adverse events occurred in 57.1% of patients. The combination demonstrated durable clinical activity and a manageable safety profile.

Jusheng An, Xiumin Li, Jing Wang, Lijing Zhu, Ruifang An, Kui Jiang, Yi Huang, Ke Wang, Guiling Li, Chunyan Wang, Jianlin Yuan, Xiaoli Hou, Guiyu Yang, Jing Li, Qingyu Wang, Jun Zhu, Lingying Wu, Fanping Meng, Rachael Rowswell-Turner