KEYNOTE-048, a randomized, open-label Phase 3 trial (ClinicalTrials.gov, NCT02358031), evaluated KEYTRUDA monotherapy or KEYTRUDA combination, compared with the EXTREME regimen, as first-line treatment in 882 patients with recurrent or metastatic HSNCC. The dual primary endpoints were OS and PFS...
Background KEYNOTE-048 (NCT02358031) is a randomized, open-label, phase 3 trial of P or P + chemotherapy (C) vs EXTREME (E) as 1L therapy for R/M HNSCC. At 2nd interim analysis, overall survival (OS) was significantly longer with P than E in patients (pts) with PD-L1 combined ...
This study is registered at ClinicalTrials.gov, number NCT02358031. Findings Between April 20, 2015, and Jan 17, 2017, 882 participants were allocated to receive pembrolizumab alone (n=301), pembrolizumab with chemotherapy (n=281), or cetuximab with chemotherapy (n=300); of these, 754 (85%...
基于德国的II/III期FLOT4研究结果,FLOT方案成为GC/GEJC的围手术期标准治疗,病理完全缓解(pCR)率为16%。全球MATTERHORN研究(NCT04592913)首次中期分析结果显示,度伐利尤单抗联合FLOT对比安慰剂联合FLOT围手术期治疗GC/GEJC患者可显著改善pCR。...
KEYNOTE-048, a randomized, open-label Phase 3 trial (ClinicalTrials.gov, NCT02358031), evaluated KEYTRUDA monotherapy or KEYTRUDA combination, compared with the EXTREME regimen, as first-line treatment in 882 patients with recurrent or metastatic HSNCC. The dual primary endpoints were OS and PFS...
This approval was based on the randomized, 3-arm, phase III KEYNOTE-048 trial (NCT02358031), with final analysis presented May 31, 2019, at the American Society of Clinical Oncology Annual Meeting (see page 70).1 The trial examined 882 patients who received either pembrolizumab...
PURPOSE The phase III KEYNOTE-048 (ClinicalTrials.gov identifier: NCT02358031) trial of pembrolizumab in recurrent or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) included planned efficacy analyses in the total population and in participants with programmed death ligand-1 (PD-L1...
japanesepembrolizumabtotal studyBackground The global ph 3 KEYNOTE-048 studied pembrolizumab (P) or P+chemotherapy (C) vs EXTREME (E) as 1L treatment (tx) for recurrent/metastatic (R/M) HNSCC (NCT02358031). Methods Patients (pts) with R/M HNSCC and no prior systemic tx (for R/M) ...
KEYNOTE-048 (NCT02358031) is a randomized, open-label, phase 3 trial of pembrolizumab (pembro) or pembro + chemotherapy (chemo) vs EXTREME (E) as first-line therapy for recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). At the second interim analysis, overa...