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
  • 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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