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Surufatinib in Combination with Toripalimab Demonstrates Antitumor Responses in Previously Treated Patients with Gastric or Gastroesophageal Adenocarcinoma

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Gastric and gastroesophageal junction (GEJ) adenocarcinoma are among the most common cancers and are the third leading cause of cancer-related mortality worldwide.1 The incidence of each cancer type varies by geographic region, with a higher incidence in Asia, Central and Eastern Europe, and Latin America, and declining incidences of gastric cancer in Western Europe and the United States.1 Despite this decline, the incidence of GEJ adenocarcinoma is on the rise in Western Europe and the United States.1 As a majority of cases are asymptomatic or nonspecific in the early stages, approximately 40% of cases are not diagnosed until they are in the advanced stages, leading to a poor prognosis and limited effective treatment options.1 Cytotoxic chemotherapy with the addition of trastuzumab or ramucirumab has been used as first- and/or second-line therapies for gastric and GEJ adenocarcinoma.1 The need for expanded treatment options has led to several clinical trials, including a phase 2 study evaluating the effectiveness of surufatinib in combination with toripalimab in solid tumors, including advanced gastric and GEJ adenocarcinoma. Surufatinib is a kinase inhibitor that targets VEGFRs and FGFR to inhibit angiogenesis, along with CSF-1R to limit its expression in the tumor microenvironment. Toripalimab is a PD-1 inhibitor.

In this clinical trial, 21 patients with gastric or GEJ adenocarcinoma who failed first-line chemotherapy were enrolled and administered 250 mg surufatinib once a day and 240 mg toripalimab intravenously every 3 weeks. The median patient age was 58 years, and 81% of participants were male. The study’s primary end point was objective response rate (ORR), determined by RECIST version 1.1. There were 15 patients who had ≥1 post-baseline efficacy evaluations. These evaluations found that 2 patients had a confirmed partial response to treatment, 3 patients had unconfirmed partial responses to treatment, and 6 patients had stable disease with treatment. Progressive disease was found in 3 patients and 1 patient remained unevaluable. Per immune-related RECIST, 5 patients had a partial response, 7 patients had stable disease, and 2 patients had progressive disease.

The confirmed ORR was 13.3% and the unconfirmed ORR was 33.3%. The disease control rate was 73.3%, and the median progression-free survival was 3.71 months. Analysis of treatment-related adverse events found 14.3% of patients had a grade ≥3 adverse event (AE). The most common treatment-related AEs were anemia, lymphopenia, decreased lymphocyte count, decreased white blood cell count, herpes zoster, and liver injury. One patient had a serious treatment-related event, and 1 patient died during the study from unknown causes.

The patient responses and the manageable treatment-related AEs make treatment with surufatinib in combination with toripalimab a promising therapy for patients with previously treated gastric or GEJ adenocarcinoma.


Shen L, Lu M, Chen Z, et al. Phase II trial of surufatinib plus toripalimab for disease progression after first-line chemotherapy with platinum and fluoropyrimidine in advanced gastric or gastroesophageal junction adenocarcinoma. J Clin Oncol. 2021;39(suppl_15):e16040.


  1. Hsu A, Zayac AS, Eturi A, Almhanna K. Treatment for metastatic adenocarcinoma of the stomach and gastroesophageal junction: 2020. Ann Transl Med. 2020;8:1109.

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