Phase II study of enlonstobart (SG001), a novel PD-1 inhibitor in patients with PD-L1 positive recurrent/metastatic cervical cancer
Year: 2024
Type: article
Study design: Clinical Trial
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).
Source: Gynecologic Oncology
Institutions: Wuhan Union Hospital, Huazhong University of Science and Technology, Peking University Cancer Hospital, West China Second University Hospital of Sichuan University, Fujian Medical University, Fujian Provincial Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Shanxi Provincial Cancer Hospital, Hebei Medical University, Fourth Hospital of Hebei Medical University, First Affiliated Hospital of Gannan Medical University, Harbin Medical University, Third Affiliated Hospital of Harbin Medical University, Qingdao University, Jiangmen Central Hospital, Jinzhou Medical University, Dalian Medical University, Second Affiliated Hospital of Dalian Medical University, University of Science and Technology of China, Shanxi Medical University, Second Hospital of Shanxi Medical University, CSPC Pharmaceutical Group, Cancer Hospital of Chinese Academy of Medical Sciences
Language: English
Subfield: Oncology
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $4,060
OpenAlex ID: W4403665595