• Tien-Hua Chen, Peter Mu-Hsin Chang, and Muh-Hwa Yang.
• Division of Medical Oncology, Department of Oncology, Taipei Veterans General Hospital; Taipei, Taiwan, ROC.
• J Chin Med Assoc. 2021 Apr 1; 84 (4): 361-367.

BackgroundImmunotherapy has become the current standard of care for recurrent and metastatic head and neck squamous cell carcinoma (R/M HNSCC). One potential approach to improve immunotherapy efficacy is to combine pembrolizumab, an anti-PD-1 agent, with lenvatinib, a potent multikinase inhibitor. In this study, we presented our up-to-date experience with pembrolizumab/lenvatinib combination therapy in heavily pretreated R/M HNSCC.MethodsPatients who had R/M HNSCC, were ineligible for curative treatment, progressed after at least two lines of systemic treatment and had received pembrolizumab/lenvatinib combination therapy were enrolled in this study. The primary endpoint was the objective response rate. The secondary endpoints included the disease control rate, overall survival, progression-free survival, and the duration of response.ResultsA total of 14 patients were enrolled in this study. All the patients had received at least two lines of systemic treatment and radiation therapy, and 71% of patients had failed previous anti-PD-1 treatment. The objective response rate of pembrolizumab/lenvatinib combination therapy was 28.6% (95% confidence interval [CI], 5.0%-52.2%). The disease control rate was 42.9% (95% CI, 17.0%-68.8%). The overall survival and progression-free survival were 6.2 months (95% CI, 2.9-9.6) and 4.6 months (95% CI, 0.05-0.9.2), respectively. Of those who had failed previous anti-PD-1 therapy, partial responses were observed in two patients. All the patients with partial responses were in the tumor proportion score <50 and combined positive score 1 to 19 groups.ConclusionOur study provided up-to-date evidence that pembrolizumab/lenvatinib combination therapy achieved objective responses in both heavily pretreated and anti-PD-1 refractory R/M HNSCC patients. This study supported the use of pembrolizumab/lenvatinib combination therapy in R/M HNSCC patients without standard of care.Copyright © 2021, the Chinese Medical Association.

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