Camrelizumab plus chemotherapy or apatinib in the first-line treatment of recurrent or metastatic head and neck squamous cell carcinoma: A double-cohort phase II study.

Abstract

e18005 Background: Targeting vascular endothelial growth factor receptor (VEGFR) may synergistically enhance the antitumor effects of immune checkpoint inhibitors (ICIs). This study evaluated the efficacy and safety of camrelizumab with chemotherapy (Arm A) or apatinib (Arm B) as first-line treatment in patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC). Methods: This open-label, double-cohort, multicenter, phase II study (NCT05156970) enrolled patients with recurrent or metastatic HNSCC who had not received prior systemic therapy for metastatic or recurrent disease. In Arm A, patients received camrelizumab (200 mg intravenous, day 1), followed by docetaxel (75 mg/m²) and cisplatin (75 mg/m²) or carboplatin (area under the curve 5) on day 2 every 3 weeks for up to six cycles, followed by camrelizumab monotherapy (200 mg intravenous, day 1, every 3 weeks). In Arm B, patients received camrelizumab (200 mg intravenous, day 1, every 3 weeks) plus oral apatinib (250 mg daily). The primary endpoint was overall survival (OS). Secondary endpoints included objective response rate (ORR), progression-free survival (PFS), and safety. Results: Between July 2021 and May 2024, 81 patients were enrolled (41 in Arm A and 40 in Arm B). The median follow-up was 11.93 months. The median OS was 16.40 months (95% confidence interval [CI], 4.13-28.67) in Arm A and 21.00 months (95% CI, 16.63-25.37) in Arm B. The median PFS was 4.57 months (95% CI, 1.11-8.03) in Arm A and 4.20 months (95% CI, 0.00-8.54) in Arm B. The ORR was 46.3% (95% CI, 32.0%-61.0%) in Arm A and 50.0% (95% CI, 35.0%-65.0%) in Arm B. Grade 3 or higher treatment-related adverse events occurred in six patients (14.6%) in Arm A and seven (17.5%) in Arm B. Conclusions: Camrelizumab combined with chemotherapy or apatinib demonstrated encouraging survival outcomes, with a favorable safety profile. These findings support further investigation of camrelizumab-based regimens as first-line treatments for patients with recurrent or metastatic HNSCC. Clinical trial information: NCT05156970 .