Phase II study of enlonstobart (SG001), a novel PD-1 inhibitor in patients with PD-L1 positive recurrent/metastatic cervical cancer

Gynecol Oncol. 2024 Dec:191:165-171. doi: 10.1016/j.ygyno.2024.10.001.

Guiling Li ¹, Xiaofan Li ², Rutie Yin ³, Mei Feng ⁴, Jing Zuo ⁵, Shuqing Wei ⁶, Shan Kang ⁷, Hongmei Sun ⁸, Xiumin Li ⁹, Yili Wang ¹⁰, Yunyan Zhang ¹¹, Li Sun ¹², Daren Lin ¹³, Xiaohong Ruan ¹³, Zhitu Zhu ¹⁴, Kui Jiang ¹⁵, Hu Liu ¹⁶, Wei Wang ¹⁷, Deshun Hao ¹⁸, Ying Chen ¹⁸, Silong Xiang ¹⁸, Miao Niu ¹⁸, Lingying Wu ¹⁹

Affiliations

1 Department of Gynecologic Oncology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China.
2 Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Radiation Oncology, Peking University Cancer Hospital & Institute, Beijing, China.
3 Department of Obstetrics and Gynecology, West China Second University Hospital, Chengdu, Sichuan, China.
4 Department of Gynecology, Fujian Cancer Hospital & Fujian Medical University Cancer Hospital, Fuzhou, Fujian, China.
5 Department of Gynecology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
6 Department of Geriatrics, Shanxi Provincial Cancer Hospital, Taiyuan, Shanxi, China.
7 Department of Obstetrics and Gynecology, Hebei Medical University Fourth Affiliated Hospital and Hebei Provincial Tumor Hospital, Shijiazhuang, Hebei, China.
8 Department of Oncology, Jiamusi Cancer and Tuberculosis Hospital, Jiamusi, Heilongjiang, China.
9 Department of Gynecologic Oncology, Linyi Cancer Hospital, Linyi, Shandong, China.
10 Department of Oncology, The First Affiliated Hospital of Gannan Medical University, Ganzhou, Jiangxi, China.
11 Department of Radiation Oncology, Harbin Medical University Cancer Hospital, Harbin, Heilongjiang, China.
12 Department of Gynecologic Oncology, The Second Affiliated Hospital of Medical College of Qingdao University, Qingdao Central Hospital, Qingdao, Shandong, China.
13 Department of Oncology, Jiangmen Central Hospital, Jiangmen, Guangdong, China.
14 Department of Oncology, The First Affiliated Hospital of Jinzhou Medical University, Jinzhou, Liaoning, China.
15 Department of Oncology, The Second Affiliated Hospital of Dalian Medical University, Dalian, Liaoning, China.
16 Department of Oncology, The First Affiliated Hospital of USTC, Anhui Provincial Cancer Hospital, Hefei, Anhui, China.
17 Department of Gynecology, The Second Hospital of Shanxi Medical University, Taiyuan, Shanxi, China.
18 CSPC Zhongqi Pharmaceutical Technology Co., Ltd, Shijiazhuang, Hebei, China.
19 Department of Gynecology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. Electronic address: wulingying@csco.org.cn.

PMID: 39447517 DOI: 10.1016/j.ygyno.2024.10.001

Abstract

Background: Platinum-based chemotherapy with or without bevacizumab is the first-line treatment for patients with recurrent or metastatic cervical Cancer (r/mCC), and the treatment options are limited for r/mCC after first-line treatment. Enlonstobart (SG001) is a fully humanized and high-affinity anti-PD-1 immunoglobulin G4 monoclonal antibody. Previous phase Ib study demonstrated that SG001 had a promising efficacy in patients with PD-L1 positive r/mCC.

Methods: In this multicenter, single-arm, open-label, phase II study, eligible patients were ≥ 18 years with PD-L1-positive cervical Cancer who had progression on or intolerance to the first-line platinum-based chemotherapy. Patients received SG001 240 mg every two weeks for 24 months or until disease progression, intolerable toxicities, or Other study discontinuation criteria were met. The primary endpoint was confirmed objective response rate (ORR) assessed by RECIST version 1.1 by independent review committee.

Results: 107 patients were enrolled with median age of 53 years (range 26-72). 64.5 % of patients had a ECOG of 1. After a median follow-up of 14.0 months (range 0.4-21.9), confirmed ORR was 29.0 %, with two complete responses and twenty-nine partial responses. The disease control rate was 54.2 %. Median duration of response was 16.6 months (95 % CI 10.8-NA), median progression free survival was 3.1 months (95 % CI 2.2-6.9). Median overall survival was not reached. 104 patients (97.2 %) experienced at least one treatment emergent adverse events TEAEs, of which 38 patients (35.5 %) had grade 3 or higher TEAEs. The most common treatment-related adverse events were leukopenia (19.6 %), increased aspartate aminotransferase (18.7 %), anemia (17.8 %), increased alanine aminotransferase (15.9 %), hypothyroidism (15.0 %), neutropenia (15.0 %), and hyperthyroidism (11.2 %).

Conclusion: SG001 monotherapy demonstrated durable anti-tumor activity with acceptable safety in patients with PD-L1 positive r/mCC with progression on or intolerance to the first-line platinum-based chemotherapy.

Trial registration: ClinicalTrials.gov (NCT04886700).

Keywords

Cervical cancer; Efficacy; Enlonstobart; PD-L1; SG001; Safety.

Products

Cat. No.

Product Name

Description

Target

Research Area
HY-P991352

SG-001

Anti-PDCD1/PD-1/CD279 mAb

PD-1/PD-L1

Cancer

Name
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