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Clin Cancer Res. 2019 Mar 4. pii: clincanres.2994.2018. doi: 10.1158/1078-0432.CCR-18-2994. [Epub ahead of print]

Surufatinib in advanced well-differentiated neuroendocrine tumors: a multicenter, single-arm, open-label, phase Ib/II trial.

Xu JM1, Li J2, Bai CM3, Xu N4, Zhou Z5, Li Z6, Zhou C7, Jia R8, Lu M9, Cheng Y10, Mao C11, Wang W12, Cheng K13, Su C14, Hua Y15, Qi C16, Li J17, Wang W18, Li K19, Sun Q20, Ren Y21, Su W21.

Author information

1
Department of Gastrointestinal Oncology, The Fifth Medical Center, General Hospital of People's Liberation Army, Beijing, China jmxu2003@yahoo.com.
2
Department of Gastrointestinal Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Peking University Cancer Hospital and Institute.
3
medical Oncology, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences.
4
Medical Oncology, First Affiliated Hospital Zhejiang University.
5
Department of Gastric Surgery, Sun Yat-sen University Cancer Center.
6
The Department of Abdominal Oncologyand The Department of Radiation Oncology, Cancer Center, State Key Laboratory of Biotherapy, West China Hospital of Sichuan University.
7
Deparment of Oncology, Shanghai Pulmonary Hospital.
8
Department of Gastrointestinal Oncology, The Fifth Medical Center, General Hospital of People's Liberation Army.
9
Department of Gastrointestinal Oncology, Key Laboratory of Carcinogenesis and Translational Research, Ministry of Education, Peking University School of Oncology, Beijing Cancer Hospital and Institute.
10
Medical Oncology, Peking Union Medical College Hospital.
11
Cancer Center, First Affiliated Hospital, Zhejiang University School of Medicine.
12
Department of Gastric Surgery, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China.
13
the State Key Laboratory of Biotherapy, West China Hospital, West China Medical School, Sichuan University, Department of Medical Oncology, Cancer Center.
14
Department of Medical Oncology, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Tongji University Medical School Cancer Institute.
15
Department of Clinical Development and Regulatory Affairs, Hutchison MediPharma Limited.
16
Clinical development and Regulatory Affairs, Hutchson MediPharma Ltd.
17
Department of Clinical Development and Regulatory Affairs, Hutchison MediPharma Ltd.
18
School of Mathematical Sciences, Shanghai Jiao Tong University.
19
Hutchison MediPharma Limited.
20
Oncology Research, Hutchison MediPharma Limited.
21
Oncology Research, Hutchison MediPharma Ltd.

Abstract

PURPOSE:

No anti-angiogenic treatment is yet approved for extrapancreatic neuroendocrine tumors (NETs). Surufatinib (HMPL-012, previously named sulfatinib) is a small molecule inhibitor targeting vascular endothelial growth factor receptors, fibroblast growth factor receptor 1 and colony stimulating factor 1 receptor. We conducted a single-arm phase Ib/II study of surufatinib in advanced NETs.

EXPERIMENTAL DESIGN:

Patients with histologically well-differentiated, low or intermittent grade, inoperable or metastatic NETs were enrolled into a pancreatic or extrapancreatic NETs cohort. Patients were treated with surufatinib 300 mg orally, once daily. The primary endpoints were safety and objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumors (version 1.1).

RESULTS:

Of the 81 patients enrolled, 42 had pancreatic NETs, and 39 had extrapancreatic NETs. Most patients had radiological progression within one year prior to enrollment (32 patients in each cohort). In the pancreatic and extrapancreatic NETs cohorts, ORRs were 19% (95% CI 9-34) and 15% (95% CI 6-31), disease control rates were 91% (95% CI 77-97) and 92% (95% CI 79-98), and median progression-free survival was 21.2 months (95% CI 15.9-24.8) and 13.4 months (95% CI 7.6-19.3), respectively. The most common grade ≥3 treatment-related adverse events were hypertension (33%), proteinuria (12%) hyperuricemia (10%), hypertriglyceridemia and diarrhea (6% for each), and increased alanine aminotransferase (5%).

CONCLUSIONS:

Surufatinib showed encouraging anti-tumor activity and manageable toxicities in patients with advanced NETs. Two ongoing phase III studies, validating the efficacy of surufatinib in patients with NETs, will contribute to the clinical evidence.

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