Camrelizumab Plus Famitinib in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma: A Phase 2 Study.

Abstract

To evaluate the outcomes of patients with refractory recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) treated with camrelizumab combined with famitinib following platinum-based chemotherapy. In this multicenter, phase 2, single-arm trial, patients with R/M HNSCC who had documented progression after platinum-based chemotherapy were administered camrelizumab 200 mg every 3 weeks and famitinib at 20 mg once daily (cohort 1). The primary endpoint was the objective response rate (ORR). The key secondary endpoints included progression-free survival (PFS), duration of response (DOR), time to objective response (TTR), disease control rate (DCR), overall survival (OS), and safety. Between August 07, 2020 and June 22, 2022, a total of 20 patients with R/M HNSCC were enrolled. The median age of the patients was 61 years (range, 37-69). The ORR was 35.0% (95% CI, 15.4-59.2) and the DCR was 55.0% (95% CI, 31.5-76.9). The median TTR was 2.23 months (95% CI, 2.0-8.3), the median DOR was 8.0 months (95% CI, 2.2 to not reach), the median PFS was 4.1 months (95% CI, 1.7-10.3), and the median OS was 8.4 months (95% CI, 3.0-17.0), with a median follow-up duration of 7.2 months (range 0.1 months to 19.6 months). Treatment-related adverse events (TRAEs) of grade ≥ 3 included decreased white blood cell count (15.0%), hypertension (15.0%), pneumonia (15.0%), and tumor bleeding (15.0%). The most common TRAEs of any grade were decreased white blood cell count (50.0%), anemia (50.0%), hypertension (50.0%), and decreased platelet count (45.0%). In this single-arm phase II trial, camrelizumab plus famitinib demonstrated encouraging efficacy and a manageable safety profile in patients with refractory R/M HNSCC. These preliminary findings warrant further investigation. ClinicalTrials.gov identifier: NCT04346381.