J Immuno Cancer: A Comparative Analysis of Phase III Clinical Trials for The Treatment of Head and Neck Squamous Cell Carcinoma Patients with Anti-PD1 Single Drug

Two Phase III clinical trials (CheckMate 141 and KEYNOTE 040) have independently demonstrated that the total lifetime (OS) of patients with failed platinum-based treatment can be improved with anti-PD1 monotorth therapy in patients with recurrent and/or metastatic head and neck squamous cell carcinoma (R/M HNSCC)compared to standard care (SOC) chemotherapy monodrug (especially citoxitamitis, dositaor, or methotrexate), R/M HNSCC patients use nivolumab or pembrolizumab treatment to improve OS, the risk ratio (HR) 0.70 (95% CI 0.51-0.96; p - 0.01) and 0.80 (95% CI 0.65-0.98, p - 0.0161) respectivelyThe gains of OS were similar in the two studies, highlighting the role of anti-PD1 drugs in patients with R/M HNSCCOne of the significant differences between CheckMate 141 and KEYNOTE 040 was the OS observed in the control group SOC (the median of KEYNOTE 040 was 6.9 months and the median of CheckMate 141 was 5.1 months), which inadvertently set a high threshold in the biostatistical analysis of 040, so the clinical results of each patient in the analysis had an impactour comparative analysis of the two studies to identify potential factors in the control group that could affect the biostatistical results of clinical trials may have an impact on futureimmuno
therapeutic clinical trial design