![]() results in our cohort, a median OS of 9 months is in keeping with the. The pembrolizumab monotherapy and combination arms had similar response rates, PFS, and AE profiles. Results of the KEYNOTE-048 trial also reported improved OS for pembrolizumab monotherapy and pembrolizumab in combination with chemotherapy, versus. Keynote-048 study was subsequently published in which they reported profound. The pembrolizumab plus chemotherapy combination versus EXTREME also improved overall survival in all 3 populations. Methods: KEYNOTE-048 was a randomised, phase 3 study of participants with untreated locally incurable recurrent or metastatic HNSCC done at 200 sites in 37 countries. The adverse event (AE) profile showed that there were less serious AEs in patients who received pembrolizumab monotherapy. Background: Pembrolizumab is active in head and neck squamous cell carcinoma (HNSCC), with programmed cell death ligand 1 (PD-L1) expression associated with improved response. Response rates were lower with pembrolizumab monotherapy versus EXTREME in the overall population, but the duration of response was longer. Protocol-specified final analysis of the phase 3 KEYNOTE-048 trial of pembrolizumab (pembro) as first-line therapy for recurrent/metastatic head and neck. Purpose: The phase III KEYNOTE-048 ( 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) combined positive score (CPS) 1 and CPS. References : Rischin D, Harrington KJ, Greil R, et al. In the total population, pembrolizumab monotherapy showed no PFS improvements and was noninferior, but it did not meet the superiority threshold. The positive results of KEYNOTE-048 represent significant progress in our field for our patients facing the challenges of R/M HNSCC. Pembrolizumab monotherapy versus EXTREME showed significantly improved OS in patients with PD-L1 CPS ≥20 and CPS ≥1. The regimens were investigated in 3 populations: patients who had a PD-L1 combined positive score (CPS) of ≥20 and ≥1, and in the overall population. 048 trial that CPI therapy alone or together with chemotherapy is an effective treatment for. Danny Rischin, MD, director, Division of Cancer Medicine, head, Department of Medical Oncology, Peter MacCallum Cancer Centre, discusses the phase III KEYNOTE-048 trial, which examines pembrolizumab (Keytruda) or pembrolizumab plus chemotherapy versus EXTREME as first-line therapy for patients with recurrent/metastatic head and neck squamous cell carcinoma. Conclusion: Our findings confirm the results of the KEYNOTE-. Danny Rischin, MD, director, Division of Cancer Medicine, head, Department of Medical Oncology, Peter MacCallum Cancer Centre, discusses results from the protocol-specified final analysis of the phase III KEYNOTE-048 trial of pembrolizumab (Keytruda) as frontline therapy for recurrent/metastatic head and neck squamous cell carcinoma.
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