Penpulimab combined with anlotinib in patients with R/M HNSCC after failure of platinum-based chemotherapy: a single-arm, multicenter, phase Ⅱ study
Yuankai Shi, Lei Gao, Ye Tian, Chunxue Bai, Junhui Chen, Jing Wang, Xiaoling Li, Cheng Zhang, Ying Sun, Hua Su, Zhong Wu Liu
Abstract
•Penpulimab combined with anlotinib demonstrated promising efficacy in R/M HNSCC patients.•Manageable safety was observed in R/M HNSCC patients treated with penpulimab combined with anlotinib.•These results support further study of penpulimab combined with anlotinib in R/M HNSCC. BackgroundTreatment 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.Patients and methodsHere, 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.ResultsOf 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.ConclusionPenpulimab combined with anlotinib demonstrated promising efficacy and manageable safety in R/M HNSCC patients after failure of platinum-based chemotherapy. 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.