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155P - Surufatinib plus toripalimab for 2L treatment of advanced gastric or gastroesophageal junction (G/GEJ) adenocarcinoma, esophageal squamous cell carcinoma (ESCC) and neuroendocrine carcinoma (NEC): A multicenter, single-arm phase 2 study


09 Dec 2021


On-Demand e-Posters Display


Ming Lu


Annals of Oncology (2021) 32 (suppl_7): S1428-S1457. 10.1016/annonc/annonc787


M. Lu1, X. Yu2, Z. Chen3, Y. Zhang4, Z. Li5, X. Zhang6, F. Yin7, F. Ye8, Y. Cheng9, L. Song10, J. Xu11, J. Zhou12, H. Shi12, P. Tan12, S. Fan12, W. Su12, L. Shen13

Author affiliations

  • 1 Peking University Cancer Hospital & Institute, 100000 - Beijing/CN
  • 2 Fudan University Shanghai Cancer Center, Shanghai/CN
  • 3 The Second Hospital of Anhui Medical University, Heifei/CN
  • 4 Harbin Medical University Cancer Hospital, Harbin/CN
  • 5 West China Hospital of Sichuan University, Chengdu/CN
  • 6 Collaborative Innovation Center for Cancer Medicine, Sun Yat-Sen University Cancer Center, Guangzhou/CN
  • 7 The Fourth Hospital of Hebei Medical University, Shijiazhuang/CN
  • 8 The First Affiliated Hospital of Xiamen University, Xiamen/CN
  • 9 Jilin Cancer Hospital, Chaoyang Borough, 130021 - Changchun/CN
  • 10 The First Affiliated Hospital of Zhengzhou University, Zhengzhou/CN
  • 11 The Fifth Medical Center, General Hospital of the People's Liberation Army, Beijing/CN
  • 12 HUTCHMED, Shanghai/CN
  • 13 Peking University Cancer Hospital & Institute, Beijing/CN


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Abstract 155P


Surufatinib (S, a small-molecule inhibitor of VEGFR1-3, FGFR1 and CSF-1R) plus toripalimab (T, an anti-PD-1 antibody) showed encouraging antitumor activity in solid tumors. Here, we report the results of 3 cohorts of advanced G/GEJ adenocarcinoma, ESCC and NEC of an ongoing, multi-cohort, phase 2 study of S + T (NCT04169672).


Patients (pts) with histologically confirmed G/GEJ adenocarcinoma or advanced/metastatic ESCC or advanced NEC who progressed after 1L systemic chemotherapy were enrolled in cohorts A, B, C, respectively. Eligible pts received 21-day cycles of S (250 mg orally QD) plus T (240 mg IV, Q3W). The primary endpoint was objective response rate (ORR) per RECIST 1.1.


Sixty-two pts were enrolled, 21, 20, 21 in cohorts A, B, C, respectively. At data cutoff (Aug 1, 2021), 61 pts (20, 20, 21 in cohorts A, B, C) had at least one post baseline tumor assessment; of them, the confirmed ORR (95%CI) were 30% (11.89-54.28), 30% (11.89-54.28), 23.8% (8.22-47.17) in cohorts A, B, C, respectively, and DCR (95%CI) were 80% (56.34-94.27), 60% (36.05-80.88), 71.4% (47.82-88.72). Median PFS (mPFS) (95%CI): 4.11 mo (2.60-6.90), 2.73 mo (1.25-5.45) and 4.14 mo (1.45-5.45); median OS: not reached (median duration of follow up, 10.09 mo), 9.72 mo (7.79-NR) and 10.87 mo (9.07-NR), respectively. In subgroups of PD-L1 positive pts, in cohort A (defined CPS ≥1), cohorts B and C (CPS ≥5), respectively, the confirmed ORR: 37.5% (15.20-64.57) in 16 pts, 38.5% (13.86-68.42) in 13 pts and 22.2% (2.81-60.01) in 9 pts; mPFS: 4.50 mo (2.60-7.59), 4.27 mo (1.25-5.72) and 5.32 mo (1.18-11.50), respectively. In overall pts (n=62), 27 (43.5%) pts reported G≥3 TRAEs, most commonly (≥3 pts) with neutrophil count decreased, WBC decreased, anemia, hypertension (4 [6.5%], each); and hypertriglyceridemia, hyperglycemia (3 [4.8%], each). Two (3.2%) pts had TRAEs led to treatment discontinuation or death.


S + T exhibited promising efficacy and manageable toxicity in pts with previously treated advanced G/GEJ adenocarcinoma, ESCC and NEC, especially for PD-L1 positive pts.

Clinical trial identification


Editorial acknowledgement

We thank Xia Yin (medical writer of HUTCHMED) for the abstract editing work.

Legal entity responsible for the study





J. Zhou, H. Shi, P. Tan, S. Fan, W. Su: Financial Interests, Personal, Full or part-time Employment: HUTCHMED. All other authors have declared no conflicts of interest.

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