Multicenter phase 3 trial of standard chemoradiotheray with concurrent and adjuvant camrelizumab for high risk nasopharyngeal carcinoma

A phase 3 trial at seven centers in China assesed treatment with camrelizumab (anti-PD-1) in addition to concurrent chemoradiotherapy and as maintenance treatment in patients with high risk nasopharyngeal carcinoma (NPC). Patients aged 18 to 70 years with newly diagnosed high risk NPC after three cycles of induction chemotherapy with gemcitabine and cisplatin were randomly assigned to receive combination chemoradiotherapy based on cisplatin (standard treatment group; n=196) or standard treatment with 19 cycles of intravenous camrelizumab (200 mg) once every three weeks (radiotherapy plus two concurrent cycles and 17 adjuvant cycles; camrelizumab group; n=194). Primary endpoint was progression-free survival (PFS). At a median follow-up of 39.9 months (IQR 36.8-43.4), PFS was higher in the camrelizumab group than in the standard treatment group (at 36 months: 83.4% versus 71.3%; sHR 0.51; p=0.001), as were distant metastasis-free survival and locoregional recurrence-free survival. The incidence of acute and late adverse events (grade 3 or 4) was 50.5% and 3.2% in the camrelizumab group compared with 48.7% and 3.7% in the standard treatment group; immunological adverse events (grade 3 or 4) occurred in 10.2% of patients in the camrelizumab group. The authors conclude that the addition of camrelizumab to concurrent chemoradiotherapy and as maintenance treatment improved progression-free survival among patients with high risk NPC after induction chemotherapy.