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- Title
Penpulimab, an anti-PD1 IgG1 antibody in the treatment of advanced or metastatic upper gastrointestinal cancers.
- Authors
Zheng, Yulong; Mislang, Anna Rachelle Austria; Coward, Jermaine; Cosman, Rasha; Cooper, Adam; Underhill, Craig; Zhu, Jianqing; Xiong, Jianping; Jiang, Ou; Wang, Hong; Xie, Yanru; Zhou, Yuefen; Jin, Xiaoping; Li, Baiyong; Wang, Zhongmin Maxwell; Kwek, Kon Yew; Xia, Dennis; Xia, Yu; Xu, Nong
- Abstract
Background: The safety and anti-tumor activity of penpulimab in patients with advanced upper gastrointestinal (UGI) cancers were evaluated in this study. Methods: Patients with advanced UGI cancers naive to immune checkpoint inhibitors were enrolled in two trials of penpulimab. In the Phase Ia/Ib trial in Australia, patients received penpulimab intravenous infusion of 1, 3 and 10 mg/kg every 2 weeks in dose-escalation phase and 200 mg every 2 weeks in dose-expansion phase. In the phase Ib/II trial conducted in China, patients received 200 mg penpulimab every 2 weeks. Primary endpoints were safety and tolerability for the phase Ia/Ib trial and the objective response rate for the phase Ib/II trial. The safety and efficacy of penpulimab in patients with UGI cancers in these two trials were evaluated. Results: A total of 67 patients with UGI cancers from Australia and China were enrolled in these two trials and had received penpulimab with a median of 6 (1–64) doses. 44.8% of patients experienced at least one treatment-related adverse event (TRAE), and 7.5% of patients experienced a grade ≥3 TRAE. Among 60 patients evaluable for response, the confirmed objective response rates ranged between 11.1 and 26.3% across cohorts for pancreatic cancer, cholangiocarcinoma, gastric or Gastroesophageal junction carcinoma (Gastric/GEJ), and hepatocellular carcinoma. 11/13 (85.0%) responders had ongoing responses at data cutoff date. Conclusions: Penpulimab monotherapy demonstrated an acceptable safety and encouraged anti-tumor activity in patients with advanced UGI cancers. Further exploration in a large cohort of patients is warranted. Trial registration: Phase Ia/Ib trial in Australia (NCT03352531) and phase Ib/II trial in China (NCT04172506).
- Subjects
AUSTRALIA; CHINA; GASTROINTESTINAL cancer; CANCER patients; IMMUNE checkpoint inhibitors; ESOPHAGOGASTRIC junction; ADVERSE health care events
- Publication
Cancer Immunology, Immunotherapy, 2022, Vol 71, Issue 10, p2371
- ISSN
0340-7004
- Publication type
Article
- DOI
10.1007/s00262-022-03160-1