Perioperative Camrelizumab (Investigational) With Chemotherapy Improves EFS in Resectable HNSCC

In the multicenter, phase 2 randomized CAMORAL trial conducted across 4 academic hospitals in China, investigators evaluated whether adding perioperative camrelizumab to chemotherapy improves event-free survival (EFS) compared with upfront surgery in untreated, resectable stage III to IVB head and neck squamous cell carcinoma (HNSCC). Between October 2020 and March 2024, 125 patients (mean age 56.3 years; 79.2% male; 82.4% with oral cavity primary tumors) were randomized 1:1 to either neoadjuvant-adjuvant treatment (n = 63) or the control group (n = 62). The experimental arm received two 21-day cycles of neoadjuvant camrelizumab (200 mg) combined with albumin-bound paclitaxel and carboplatin, followed by surgery, risk-adapted adjuvant therapy, and maintenance camrelizumab for up to 15 cycles. The control group underwent upfront surgery followed by standard risk-adapted adjuvant therapy.

At a median follow-up of 24.6 months (IQR, 16.8-36.5), the primary endpoint of 2-year EFS was 77.8% (95% CI, 63.6-87.0) in the neoadjuvant-adjuvant group versus 46.1% (95% CI, 31.3-59.6) in the control group (hazard ratio, 0.34; 95% CI, 0.17-0.68; P = .001). Perioperative chemoimmunotherapy also yielded higher 2-year overall survival rates (92.0% vs 69.1%; HR, 0.25; 95% CI, 0.10-0.64) and reduced distant failure (2-year distant metastasis-free survival HR, 0.15; 95% CI, 0.03-0.68). Major pathological responses were noted in 47.6% of patients and pathological complete responses in 25.4% within the investigational arm, whereas neither was seen in the upfront surgery arm.

Safety analysis showed that grade 3 or higher treatment-emergent adverse events were documented in 79.4% of patients receiving perioperative camrelizumab plus chemotherapy compared with 56.5% in the control arm. One fatal treatment-emergent adverse event occurred in the control arm. The authors concluded that perioperative camrelizumab plus chemotherapy significantly improved EFS with manageable toxic effects, supporting the evaluation of intensified perioperative immune priming in resectable locally advanced HNSCC.