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- Title
Efficacy and safety of surufatinib plus toripalimab, a chemotherapy-free regimen, in patients with advanced gastric/gastroesophageal junction adenocarcinoma, esophageal squamous cell carcinoma, or biliary tract cancer.
- Authors
Zhang, Panpan; Chen, Zhendong; Shi, Si; Li, Zhiping; Ye, Feng; Song, Lijie; Zhang, Yanqiao; Yin, Fei; Zhang, Xing; Xu, Jianming; Cheng, Ying; Su, Weiguo; Shi, Michael; Fan, Songhua; Tan, Panfeng; Zhong, Chen; Lu, Ming; Shen, Lin
- Abstract
Background: The programmed death 1 inhibitor toripalimab plus the angio-immuno kinase inhibitor surufatinib showed a tolerable safety profile and preliminary efficacy in patients with advanced solid tumors in a phase I study. Methods: This open-label, multi-cohort study in China enrolled patients with advanced solid tumors who had failed or were intolerable to standard treatment into tumor-specific cohorts. Patients received surufatinib (250 mg orally, once daily) plus toripalimab (240 mg intravenously, once every three weeks). Results for three cohorts (gastric/gastroesophageal junction [GC/GEJ] adenocarcinoma, esophageal squamous cell carcinoma [ESCC], and biliary tract carcinoma [BTC]) are reported here. The primary endpoint was investigator-assessed objective response rate (ORR) per Response Evaluation criteria in Solid Tumors version 1.1. Results: Between December 17, 2019, and January 29, 2021, 60 patients were enrolled (GC/GEJ, n = 20; ESCC, n = 20; BTC, n = 20). At data cutoff (February 28, 2023), ORRs were 31.6%, 30.0%, and 11.1%, respectively. Median progression-free survival was 4.1, 2.7, and 2.9 months, respectively. Median overall survival was 13.7, 10.4, and 7.0 months, respectively. Overall, grade ≥ 3 treatment-related adverse events occurred in 28 (46.7%) patients. Conclusions: Surufatinib plus toripalimab showed promising antitumor activity and a tolerable safety profile in immunotherapy-naïve patients with GC/GEJ adenocarcinoma, ESCC, or BTC. These findings warrant further study in larger randomized trials comparing surufatinib plus toripalimab with standard therapies in these tumors. ClinicalTrials.gov NCT04169672.
- Subjects
CHINA; BILIARY tract cancer; ESOPHAGEAL cancer; ESOPHAGOGASTRIC junction; SQUAMOUS cell carcinoma; BILIARY tract; ADENOCARCINOMA
- Publication
Cancer Immunology, Immunotherapy, 2024, Vol 73, Issue 7, p1
- ISSN
0340-7004
- Publication type
Article
- DOI
10.1007/s00262-024-03677-7