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Efficacy and Safety of Iparomlimab, an Anti-PD-1 Antibody, in Patients with Advanced Solid Tumors: A Phase 1c Study.
Xiong, Jianping; Ouyang, Weiwei; Yang, Mengxiang; Gao, Zhenyuan; Zhou, Huan; Lou, Hanmei; Guo, Yabing; Xu, Zhongyuan; Zheng, Ling; Liu, Ying; Wang, Zhongfeng; Sun, Ping; Niyazi, Huerxidan; Wang, Jianhua; Chen, Yan; Zhang, Baihui; Li, Lingyan; Kang, Xiaoyan; Guo, Weijian.
Afiliación
  • Xiong J; Department of Medical Oncology, The First Affiliated Hospital of Nanchang University, Nanchang, China.
  • Ouyang W; Phase I Ward, Guizhou Cancer Hospital, Guiyang, China.
  • Yang M; Department of Oncology, Liaocheng People's Hospital, Liaocheng, China.
  • Gao Z; Department of Medical Oncology, The First Affiliated Hospital of Bengbu Medical College, Bengbu, China.
  • Zhou H; Department of Medical Oncology, The First Affiliated Hospital of Bengbu Medical College, Bengbu, China.
  • Lou H; Phase I Ward, Zhejiang Cancer Hospital, Hangzhou, China.
  • Guo Y; Liver Cancer Center/Phase I Clinical Research Laboratory, Nanfang Hospital, Guangzhou, China.
  • Xu Z; Liver Cancer Center/Phase I Clinical Research Laboratory, Nanfang Hospital, Guangzhou, China.
  • Zheng L; Phase I Ward, Mengchao Hepatobiliary Hospital of Fujian Medical University, Fuzhou, China.
  • Liu Y; The Third Ward of Digestive Diseases, Henan Cancer Hospital, Zhengzhou, China.
  • Wang Z; Henan Cancer Hospital, The First Hospital of Jilin University, Changchun, China.
  • Sun P; Department of Medical Oncology, Yantai Yuhuangding Hospital, Yantai, China.
  • Niyazi H; Department of Oncology/Phase I Ward, The First Affiliated Hospital of Xinjiang Medical University, Wulumuqi, China.
  • Wang J; Department of Oncology/Phase I Ward, The First Affiliated Hospital of Xinjiang Medical University, Wulumuqi, China.
  • Chen Y; Clinical Research and Development Center, Qilu Pharmaceutical Co., Ltd, Jinan, China.
  • Zhang B; Clinical Research and Development Center, Qilu Pharmaceutical Co., Ltd, Jinan, China.
  • Li L; Clinical Research and Development Center, Qilu Pharmaceutical Co., Ltd, Jinan, China.
  • Kang X; Clinical Research and Development Center, Qilu Pharmaceutical Co., Ltd, Jinan, China.
  • Guo W; Department of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, China. guoweijian_work@163.com.
Adv Ther ; 2024 Sep 14.
Article en En | MEDLINE | ID: mdl-39276185
ABSTRACT

INTRODUCTION:

Iparomlimab (QL1604) is a humanized immunoglobulin G4 mAb against programmed cell death protein 1 (PD-1). Here, we report the preliminary efficacy, safety, pharmacokinetics, and immunogenicity of iparomlimab in patients with advanced solid tumors.

METHODS:

In this open-label, phase 1c study, patients with advanced or metastatic solid tumors, either failed or had no standard therapies available, were enrolled and received intravenous iparomlimab at 3 mg/kg once every 3 weeks. The primary efficacy endpoint was the objective response rate (ORR) assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

RESULTS:

Between July 20, 2020, and September 6, 2021, 71 patients were enrolled and received at least one dose of iparomlimab. The ORR was 9.9% (7/71) and disease control rate was 36.6% (26/71). Median duration of response of all responders was 10.7 months [95% confidence interval (CI), 1.4-not estimable]. Additionally, the median time to progression, progression-free survival, and overall survival were 1.4 months (95% CI, 1.4-2.8), 1.4 months (95% CI, 1.4-2.7), and 9.7 months (95% CI, 7.2-15.3), respectively. A total of 52 (73.2%) patients experienced treatment-related adverse events (TRAEs) (grade ≥ 3, 19.7%). The most common TRAE (≥ 10%) was anemia (18.3%). A total of 20 (28.2%) experienced immune-related adverse events (grade ≥ 3, 7.0%). TRAEs leading to discontinuation of study drug occurred in 4 (5.6%) patients, including immune-mediated myocarditis (2 patients), Guillain-Barré syndrome (1 patient), and diarrhea (1 patient).

CONCLUSIONS:

Iparomlimab showed preliminary clinical activity and had a manageable safety profile in patients with advanced solid tumors. These results support further investigation of iparomlimab as monotherapy or in combination therapy in advanced solid tumors. TRIAL REGISTRATION ClinicalTrials.gov identifier, NCT05801094. Retrospectively registered in 2023-03-24.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: Adv Ther Asunto de la revista: TERAPEUTICA Año: 2024 Tipo del documento: Article País de afiliación: China Pais de publicación: Estados Unidos
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: Adv Ther Asunto de la revista: TERAPEUTICA Año: 2024 Tipo del documento: Article País de afiliación: China Pais de publicación: Estados Unidos