Efficacy and Safety of the Anti-PD-L1 mAb Socazolimab for Recurrent or Metastatic Cervical Cancer: a Phase I Dose-Escalation and Expansion Study

作者：An, Jusheng; Tang, Jie; Li, Benjamin X.; Xiong, Huihua; Qiu, Hui; Luo, Lin; Wang, Li; Wang, Danbo; Zhou, Qi; Xu, Qin; Song, Honglin; Zhang, Yunyan; Zhang, Hongping; Li, Yujie; Yu, Xiaohui; Zhang, Jing; Ng, Rachel; Zhao, Wayne; Wong, Michael; Dai, Xiangrong; Li, Guiling^*; Wu, Lingying^*

来源：Clinical Cancer Research, 2022, 28(23): 5098-5106.

DOI：10.1158/1078-0432.CCR-22-1280

• SQUAMOUS-CELL-CARCINOMA
• PERSISTENT
• TRIAL
• BEVACIZUMAB
• CISPLATIN
• CHEMOTHERAPY
• PACLITAXEL
• SURVIVAL

Purpose: This study ( ClinicalTrials.gov identifier, NCT03676959) is an open, phase I dose-escalation and expansion study investigating the safety and efficacy of the recombinant, fully human anti-programmed death ligand 1 (PD-L1) mAb socazolimab in patients diagnosed with recurrent or metastatic cervical cancer. @@@ Patients and Methods: Patients received socazolimab every 2 weeks until disease progression. The study was divided into a dose-escalation phase and a dose-expansion phase. Safety and tolerability were primary endpoints of the dose-escalation phase. The primary endpoints of the dose-expansion phase were safety and the objective response rate (ORR) of the 5 mg/kg dose. Efficacy was assessed by the third-party independent review committee (IRC) using the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). @@@ Results: 104 patients were successfully enrolled into the study. Twelve patients were included in the dose-escalation phase, with one complete response and two partial responses in the 5 mg/kg treatment group. Ninety-two patients (5 mg/kg) were enrolled in the dose-expansion phase. Fifty-four patients (59.3%) had baseline PDL1-positive tumor expression (combined positive score =1). ORR was 15.4% [95% confidence interval (CI), 8.7%-24.5%]. Median PFS was 4.44 months (95% CI, 2.37-5.75 months), and the median OS was 14.72 months (95% CI, 9.59-NE months). ORR of PD-L1positive patients was 16.7%, and the ORR of PD-L1-negative patients was 17.9%. No treatment-related deaths occurred. @@@ Conclusions: Our study demonstrates that socazolimab has durable safety and efficacy for the treatment of recurrent or metastatic cervical cancer and exhibits a safety profile similar to other anti-PD-1/PD-L1 mAbs.

• 单位
  华中科技大学; 中国医学科学院; 中国医学科学院北京协和医院; 武汉大学; 哈尔滨医科大学