Surufatinib plus toripalimab in patients with advanced neuroendocrine tumours and neuroendocrine carcinomas: An open-label, single-arm, multi-cohort phase II trial

作者：Panpan Zhang, Si Shi, Jianming Xu, Zhendong Chen, Lijie Song, Xing Zhang, Ying Cheng, Yanqiao Zhang, Feng Ye, Zhiping Li, Fei Yin, Dongmei Ji, Heli Gao, Yi Li, Wei J. Chen, Minjie Yang, Desheng Weng, Chunjiao Wu, Yue Ma, Wang Sheng, Yaqin Zhao, Xiaolei Yin, Weina Shen, Weiguo Su, Michael Shi, Songhua Fan, Panfeng Tan, Qian Xu, Ming Lu, Lin Shen · 发表于：European Journal of Cancer · 年份：2024 · DOI：10.1016/j.ejca.2024.113539 · 被引用次数：21 · 研究领域：Neuroendocrine Tumor Research Advances、Lung Cancer Research Studies、Thyroid Cancer Diagnosis and Treatment

BACKGROUND: The programmed death 1 inhibitor toripalimab plus the angio-immuno kinase inhibitor surufatinib revealed a tolerable safety profile and preliminary efficacy in patients with advanced solid tumours in a phase I study. PATIENTS AND METHODS: This was an open-label, single-arm, multi-cohort phase II study in China. Patients with advanced neuroendocrine tumours (NETs) or neuroendocrine carcinomas (NECs) or mixed neuroendocrine non-neuroendocrine neoplasms (MiNENs) who had failed or were intolerable of standard treatment were given surufatinib (250 mg orally, once daily) plus toripalimab (240 mg intravenously, once every 3 weeks). Primary end-point was investigator-assessed objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1. Secondary end-points included duration of response (DoR), disease control rate, progression-free survival (PFS), overall survival (OS), and safety. RESULTS: Forty patients were enrolled into two cohorts by tumour types (NET, n = 19; NEC-MiNEN, n = 21). ORRs (95% CIs) were 21.1% (6.1-45.6) and 23.8% (8.2-47.2) in the NET and NEC-MiNEN cohorts, respectively. Median DoR was 7.1 months (6.9-not evaluable [NE]) and 4.1 months (3.0-NE), respectively. Median PFS was 9.6 months (4.1-NE) and 4.1 months (1.5-5.5); median OS was 27.3 (15.3-NE) and 10.9 months (9.1-14.6), respectively. Overall, grade ≥ 3 treatment-related adverse events occurred in 18 (45.0%) patients. CONCLUSIONS: Surufatinib plus toripalimab showed anti...