Adjuvant PD-1 blockade with camrelizumab in high-risk locoregionally advanced nasopharyngeal carcinoma (DIPPER): A multicenter, open-label, phase 3, randomized controlled trial.

• DOI: 10.1200/jco.2024.42.17_suppl.lba6000
• Publication Date: 2024-06-05T13:28:57Z
• Authors: Jun Ma; Ying Sun; Ye-Lin Liang; Xu Liu; Liangfang Shen; Weihan Hu; Guangyuan Hu; Fangyun Xie; Ying Huang; Guorong Zou; Ning Zhang; Chuanben Chen; Xiaozhong Chen; Xiaodong Zhu; Yawei Yuan; Kunyu Yang; Feng Jin; Shu-Bin Hong; Hongyun Zhao; Ji-Bin Li
• Keywords: Clinical endpoint; Chemoradiotherapy

LBA6000 Background: Patients with high-risk locoregionally advanced nasopharyngeal carcinoma (NPC) often experience disease relapse even after receiving standard-of-care treatment, e.g. induction chemotherapy (IC) followed by concurrent chemoradiotherapy (CCRT). The benefit of PD-1 inhibitor as adjuvant treatment following IC+CCRT in NPC remains unclear. Methods: (T4N1M0 or T1-4N2-3M0) who have received gemcitabine and cisplatin (GP) IC CCRT were recruited at 11 centers China. They randomly assigned (1:1) within 2 weeks the last radiation dose to receive intravenous camrelizumab (200 mg once every 3 for 12 cycles; Camrelizumab Arm) observation (Standard-therapy Arm). primary endpoint was event-free survival (EFS). It is estimated that approximately 442 patients would provide 80% power detect a hazard ratio (HR) 0.52 log-rank test two-sided α level 0.05. Quality life (QoL) assessed EORTC-C30. Results: A total 450 Arm (n=226) Standard-therapy (n=224). After median follow-up 37 months (corresponding 41 when calculated from start standard therapy), 3-year EFS 86.9% 77.4% (intention-to-treat population; HR 0.61, 95% CI 0.38–0.96; P = 0.03). incidence grade 3-4 adverse events (AEs) 11.2% 3.2% Arm, including immune-related AEs 8 (3.9%) Arm. Reactive capillary endothelial proliferation most common event related (RECP, 87.8%, 4 (1.8%) had RECP). Treatment-related deaths occurred 1 (<1%) group (subarachnoid hemorrhage) (nasopharyngeal necrosis). During there no clinically meaningful deterioration health-related quality associated use camrelizumab. Conclusions: Adjuvant blockade significantly improved NPC, mild toxicity comparable life. Clinical trial information: NCT03427827 . [Table: see text]