Efficacy and safety of sintilimab plus bevacizumab in metastatic nasopharyngeal carcinoma after failure of platinum-based chemotherapy: An open-label phase II study.

person Nian Lu Caner Center, Sun Yat-Sen University, State Key Laboratory of Oncology in South China, Collaborative Innovation Center of Cancer Medicine, Guangzhou, China info_outline Nian Lu, Yao-fei Jiang, Weixiong Xia, Ying Huang, Chuan-miao Xie, Cheng Xu, Yan-Fang Ye, Guo-Ying Liu, Wei-Xin Bei, Liang-Ru Ke, Wang-Zhong Li, Xin Wang, Changqing Xie, Hu Liang, Xiang Yanqun

Authors person Nian Lu Caner Center, Sun Yat-Sen University, State Key Laboratory of Oncology in South China, Collaborative Innovation Center of Cancer Medicine, Guangzhou, China info_outline Nian Lu, Yao-fei Jiang, Weixiong Xia, Ying Huang, Chuan-miao Xie, Cheng Xu, Yan-Fang Ye, Guo-Ying Liu, Wei-Xin Bei, Liang-Ru Ke, Wang-Zhong Li, Xin Wang, Changqing Xie, Hu Liang, Xiang Yanqun Organizations Caner Center, Sun Yat-Sen University, State Key Laboratory of Oncology in South China, Collaborative Innovation Center of Cancer Medicine, Guangzhou, China, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, China, Sun Yat-sen University Cancer Center, Guangzhou, China, Department of Radiation Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center of Cancer Medicine, Guangzhou, China, Clinical Research Design Division, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, China, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, China, Department of Nasopharyngeal Carcinoma, Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center of Cancer Medicine, Guangzhou, China, Department of Medical Imaging, Sun Yat-Sen University Cancer Center, Guangzhou, China, Department of Thoracic Surgery and Oncology, the First Affiliated Hospital of Guangzhou Medical University, State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, Guangzhou, China, Thoracic and GI Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institute of Health, Bethesda, OH, Thoracic and GI Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD Abstract Disclosures Research Funding Other Foundation National Natural Science Foundation of China (KY013113) Background: There are limited treatment options for patients with metastatic nasopharyngeal carcinoma (mNPC) after failure of platinum-based chemotherapy. In this trial, we assessed the efficacy and safety of sintilimab plus bevacizumab in mNPC patients where platinum-based chemotherapy has failed. Methods: This was a single-center, open-label, single-arm, phase II trial for mNPC patients progressed after at least one line of systemic therapy. Patients were enrolled and received sintilimab (200 mg) plus bevacizumab (7.5mg/kg) intravenously every 3 weeks. The primary end point was objective response rate (ORR) assessed by investigators following the guidelines of RECIST 1.1. Key secondary end points were progression-free survival (PFS), overall survival (OS), duration of response (DOR), and safety. This trial is registered with ClinicalTrials.gov (NCT04872582). Results: Thirty-three patients were enrolled. Median age was 46 years (range, 18-64 years), and 63.6% of patients had previously received two or more lines of chemotherapy for metastatic disease. Median follow-up was 7.6 months (range, 4.1-17.5 months). ORR was 54.5% (95% CI, 36.4- 71.9%) with 3 complete responses (9.1%) and 15 partial responses (45.5%). Median PFS was 6.8 months (95% CI, 5.2 months to not estimable). Median DOR was 7.2 months (95% CI, 4.4 months to not estimable). Median OS was not reached. The most common potential immune-related AE was grade 1-2 hypothyroidism (42.4%). Treatment-related grade 3 or 4 adverse events (AEs) occurred in 7 patients (21.2%), including nasal necrosis (9%), hypertension (3%), pruritus (3%), total bilirubin increased (3%) and anaphylactic shock (3%). No treatment-related deaths and severe epistaxis occurred. Conclusions: This phase II trial showed that sintilimab plus bevacizumab demonstrated promising antitumor activity and manageable toxicities in mNPC patients after failure of platinum-based chemotherapy. Clinical trial information: NCT04872582.

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