Protocol-specified final analysis of the phase 3 KEYNOTE-048 trial of pembrolizumab (pembro) as first-line therapy for recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC). J Clin Oncol. 2019;37(suppl 15; abstr 6000). doi: 10.1200/JCO.2019.37.15_suppl. 6000...
LIMITATION: This post-hoc analysis (median follow-up time: 64.6 months) in KEYNOTE-189 was exploratory in nature and occurred after the protocol-specified final analysis. No formal statistical testing was planned for this updated analysis and, therefore, no statistical conclusions can be dr...
PFS with KEYTRUDA and ipilimumab at the protocol-specified first-interim analysis (6 months) and in a 5-year post hoc extension analysis4,6 6-Month Analysis6 PFS by BICR Analysisk KEYTRUDA 10 mg/kg IV Q3W (n=277)KEYTRUDA 10 mg/kg IV Q2W (n=279)Ipilimumab IV (n=278) ...
The study was conducted in accordance with the protocol, its amendments, the Declaration of Helsinki, and the standards of Good Clinical Practice. All participants provided written informed consent. Outcomes The primary efficacy endpoints in KEYNOTE-048 (OS and progression-free survival) and secondary...
Protocol-specified final analysis of the phase 3 KEYNOTE-048 trial of pembrolizumab (pembro) as first-line therapy for recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC). J Clin Oncol. 2019;37(15):6000. doi:10.1200/JCO.2019.37.15_suppl.6000 Download PDF...
The study protocol and all amendments were approved by the appropriate ethics committee at each center. The study was conducted in accordance with the protocol, its amendments, and standards of Good Clinical Practice. All patients provided written informed consent. Assessments and outcomes Tumor respons...