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

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

  • Clin Cancer Res. 2022 Dec 1;28(23):5098-5106. doi: 10.1158/1078-0432.CCR-22-1280.
Jusheng An # 1,  Jie Tang # 2,  Benjamin X Li 3,  Huihua Xiong 4,  Hui Qiu 5,  Lin Luo 5,  Li Wang 6,  Danbo Wang 7,  Qi Zhou 8,  Qin Xu 9,  Honglin Song 10,  Yunyan Zhang 11,  Hongping Zhang 12,  Yujie Li 3,  Xiaohui Yu 3,  Jing Zhang 3,  Rachel Ng 3,  Wayne Zhao 3,  Michael Wong 3,  Xiangrong Dai 3,  Guiling Li 13,  Lingying Wu 1
Affiliations

Affiliations

  • 1 Department of Gynecologic Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
  • 2 Hunan Tumor Hospital, Hunan, China.
  • 3 Lee's Pharmaceutical Holdings Limited, Hong Kong SAR.
  • 4 Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
  • 5 Zhongnan Hospital of Wuhan University, Wuhan, China.
  • 6 Henan Cancer Hospital, Henan, China.
  • 7 Liaoning Cancer Hospital, Liaoning, China.
  • 8 Chongqing Cancer Hospital, Chongqing, China.
  • 9 Fujian Cancer Hospital, Fujian, China.
  • 10 Affiliated Tumor Hospital of Guangxi Medical University, Guangxi, China.
  • 11 Affiliated Tumor Hospital of Harbin Medical University, Heilongjiang, China.
  • 12 Yunnan Tumor Hospital, Yunnan, China.
  • 13 Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
  • # Contributed equally.
PMID: 36136294 DOI: 10.1158/1078-0432.CCR-22-1280
Abstract

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 PD-L1-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-L1-positive 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.

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