Penpulimab combined with anlotinib in patients with R/M HNSCC after failure of platinum-based chemotherapy: a single-arm, multicenter, phase Ⅱ study

Treatment regimens for recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) after failure of platinum-based chemotherapy have been illustrated with limited efficacy.Here, we report a single-arm, multicenter, phase Ⅱ study of R/M HNSCC patients treated with a programmed cell death-1 antibody penpulimab (200 mg) and anlotinib (12 mg) after failing at least one line of platinum-based chemotherapy.Of 38 patients in total, 13 (34.21%) patients achieved partial response and 16 (42.11%) patients achieved stable disease. After a median follow-up of 7.06 months (range: 4.14-15.70 months), the independent review committee-assessed objective response rate was 34.21%, the disease control rate was 76.32%. The median progression-free survival was 8.35 months (95% confidence interval 5.95-13.11 months). Twelve patients died and the median overall survival (OS) was not reached. The 12-month OS rate was 59.76%. Grade 3/4 treatment-related adverse events occurred in 47.37% of the patients.Penpulimab combined with anlotinib demonstrated promising efficacy and manageable safety in R/M HNSCC patients after failure of platinum-based chemotherapy.