Medicine and Health

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

J. An, X. Li, et al.

This phase II study explored the combination of serplulimab and nab-paclitaxel in previously treated patients with PD-L1-positive advanced cervical cancer, achieving an impressive 57.1% objective response rate and demonstrating durable clinical activity with manageable safety. Conducted by esteemed authors including Jusheng An and Xiumin Li, this research opens new avenues for cervical cancer treatment.

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Index

Abstract

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.

Publisher

Frontiers in Immunology

Published On

Apr 21, 2023

Authors

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

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