Randomized phase 2 trial of perioperative camrelizumab plus chemotherapy for locally advanced head and neck squamous cell carcinoma

Despite multimodal treatment, recurrence remains common in patients with resectable locally advanced head and neck squamous cell carcinoma (HNSCC). Whether perioperative chemoimmunotherapy improves long-term outcomes is not clear. The randomized phase 2 CAMORAL trial, at 4 centers in China, evaluated perioperative camrelizumab plus nab-paclitaxel and carboplatin chemotherapy for resectable locally advanced HNSCC. Patients aged 18 to 75 years with untreated, resectable stage III to IVB HNSCC were assigned to neoadjuvant-adjuvant treatment plus up to 15 cycles camrelizumab maintenance (n=63) or standard surgery-based treatment with risk-adapted adjuvant therapy (’control’, n=62). The primary endpoint was 2-year event-free surival (EFS) rate. The median duration of follow-up was 24.6 months (16.8-36.5). The 2-year EFS rate was77.8% (95% CI 63.6-87.0) in the neoadjuvant-adjuvant group versus 46.1% (31.3-59.6) in the control group (HR 0.34; p=0.001). Major pathological response and pathological complete response were seen in 47.6% and 25.4% in the neoadjuvant-adjuvant group, respectively, and in no patients in the control group. The 2-year overall survival rates were 92.0% and 69.1%, respectively (HR 0.25; 95% CI 0.10-0.64); the HR of 2-year distant metastasis-free survival was 0.15 (95% CI 0.03-0.68). Grade 3 or higher treatment-emergent adverse events occurred in 79.4% of patients in the neoadjuvant-adjuvant group and 56.5% of patients in the control group; 1 fatal treatment-emergent adverse event occurred in the control group. The authors conclude that perioperative camrelizumab plus chemotherapy significantly improved EFS with manageable toxic effects (visual abstract).