A phase I study of subcutaneous envafolimab (KN035) monotherapy in Chinese patients with advanced solid tumors.
10.3760/cma.j.cn112152-20220530-00373
- Author:
Rong Rui LIU
1
;
Shan Zhi GU
2
;
Tie ZHOU
3
;
Li Zhu LIN
4
;
Wei Chang CHEN
5
;
Dian Sheng ZHONG
6
;
Tian Shu LIU
7
;
Nong YANG
8
;
Lin SHEN
9
;
Si Ying XU
10
;
Ni LU
10
;
Yun ZHANG
10
;
Zhao Long GONG
10
;
Jian Ming XU
1
Author Information
1. Department of Medical Oncology, Senior Department of Oncology, the Fifth Medical Center of PLA General Hospital, Beijing 100071, China.
2. Department of Interventional Radiology, Hunan Cancer Hospital, Changsha 410031, China.
3. Department of Urology, Changhai Hospital of Shanghai, Shanghai 200433, China.
4. Cancer Center, the First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou 510405, China.
5. Department of Gastroenterology, First Affiliated Hospital to Soochow University, Suzhou 215006, China.
6. Department of Medical Oncology, Tianjin Medical University General Hospital, Tianjin 300052, China.
7. Department of Medical Oncology, Zhongshan Hospital, Fudan University, Shanghai 200032, China.
8. Lung Cancer and Gastrointestinal Unit, Hunan Cancer Hospital, Changsha 410031, China.
9. Department of Gastrointestinal Oncology, Peking University Cancer Hospital, Beijing 100142, China.
10. 3D Medicines Co. Ltd, Chengdu 610036, China.
- Publication Type:Journal Article
- Keywords:
Anti-programmed death-ligand 1 antibody;
Efficacy;
Envafolimab;
Malignant tumor;
Safety
- MeSH:
Humans;
East Asian People;
Neoplasms/pathology*;
Antibodies, Monoclonal, Humanized/therapeutic use*
- From:
Chinese Journal of Oncology
2023;45(10):898-903
- CountryChina
- Language:Chinese
-
Abstract:
Objective: To evaluate the safety and antitumor activity of envafolimab monotherapy in Chinese patients with advanced solid tumors. Methods: This open-label, multicenter phase I trial included dose escalation and dose expansion phases. In the dose escalation phase, patients received subcutaneous 0.1, 0.3, 1.0, 2.5, 5.0 or 10.0 mg/kg envafolimab once weekly (QW) following a modified "3+ 3" design. The dose expansion phase was performed in the 2.5 mg/kg and 5.0 mg/kg (QW) dose cohorts. Results: At November 25, 2019, a total of 287 patients received envafolimab treatment. During the dose escalation phase, no dose-limiting toxicities (DLT) was observed. In all dose cohorts, drug-related treatment-emergent adverse events (TEAEs) for all grades occurred in 75.3% of patients, and grade 3 or 4 occurred in 20.6% of patients. The incidence of immune-related adverse reactions (irAE) was 24.0% for all grades, the most common irAEs (≥2%) included hypothyroidism, hyperthyroidism, immune-associated hepatitis and rash. The incidence of injection site reactions was low (3.8%), all of which were grades 1-2. Among the 216 efficacy evaluable patients, the objective response rate (ORR) and disease control rate (DCR) were 11.6% and 43.1%, respectively. Median duration of response was 49.1 weeks (95% CI: 24.0, 49.3). Pharmacokinetic (PK) exposure to envafolimab is proportional to dose and median time to maximum plasma concentration is 72-120 hours based on the PK results from the dose escalation phase of the study. Conclusion: Subcutaneous envafolimab has a favorable safety and promising preliminary anti-tumor activity in Chinese patients with advanced solid tumors.
