Five-year outcome of camrelizumab plus chemotherapy for recurrent or metastatic nasopharyngeal carcinoma: multicenter phase 3 trial

The phase 3 CAPTAIN-1st trial, at 28 centers in China, evaluated addition of camrelizumab to first-line chemotherapy for patients with recurrent or metastatic nasopharyngeal carcinoma (R/M NPC). Five-year outcome of the trial has now been published. The trial included 263 patients, who were randomized to camrelizumab (n=134) or placebo (n=129) in combination with gemcitabine and cisplatin for 4 to 6 cycles, followed by maintenance camrelizumab or placebo. The median survival follow-up was 63.5 months for the camrelizumab group and 63.0 months for the placebo group. The median overall survival (OS) was 34.5 months (95% CI 29.4-45.7) with camrelizumab and 26.6 months (19.8-33.5) with placebo (HR 0.74; p=0.047; after adjusting for age imbalance HR 0.65; p=0.01). The OS benefits were generally consistent across subgroups. In the camrelizumab group, patients who achieved rapid clearance of Epstein-Barr virus (EBV) DNA had significantly longer OS compared with those without EBV DNA clearance (HR 0.32; p<0.001). The authors conclude that these findings provide the first 5-year evidence supporting the benefit of PD-1-based chemoimmunotherapy in this setting.