Trial reportInternational journal of clinical oncology2024
First-line pembrolizumab with or without chemotherapy for recurrent or metastatic head and neck squamous cell carcinoma: 5-year follow-up of the Japanese population of KEYNOTE‑048.
Trial report in International journal of clinical oncology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02358031 (A Phase 3 Clinical Trial of Pembrolizumab), which is not on this map. Cited by 6 papers, 1 of them a synthesis that pooled it.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase 3 Clinical Trial of Pembrolizumab (MK-3475) in First Line Treatment of Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
Who cites it
6 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Efficacy and safety of PD-1 inhibitors in recurrent or metastatic squamous cell carcinoma of the head and neck: a systematic review and meta-analysis.Oncology reviews · 2026Pooled it
- Real-World Efficacy of Postoperative Adjuvant Nivolumab in High-Risk Urothelial Carcinoma: A Retrospective Comparative Study in an Asian Population.Asia-Pacific journal of clinical oncology · 2026Article
- Real-world platinum selection in immune checkpoint inhibitor-based therapy for recurrent or metastatic head and neck cancer: an exploratory multi-institutional retrospective study.Scientific reports · 2026Article
- Immune biomarkers for head and neck cancer.Cancer immunology, immunotherapy : CII · 2025Review
- Next-Generation Cancer Treatment: Photoimmunotherapy's Promise for Unresectable Head and Neck Cancers.Pharmaceutics · 2025Review
- Combination of drug-eluting bead transarterial chemoembolization and PD-1 inhibitor for treatment of unresectable head and neck squamous cell carcinoma: an initial, short-term clinical experience in a single-center retrospective cohort study.Frontiers in immunology · 2025Article
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Authors and funding
24 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundPreviously reported results from phase III KEYNOTE-048 demonstrated similar or improved overall survival (OS) with pembrolizumab or pembrolizumab-chemotherapy versus cetuximab-chemotherapy (EXTREME) in Japanese patients with recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC). We report results in Japanese patients from KEYNOTE-048 after 5 years of follow-up.
methodsPatients with R/M HNSCC of the oropharynx, oral cavity, hypopharynx, or larynx were randomly assigned 1:1:1 to pembrolizumab, pembrolizumab-chemotherapy, or EXTREME. Primary endpoints were OS and progression-free survival. Efficacy was evaluated in the programmed cell death ligand 1 (PD-L1) combined positive score (CPS) ≥ 20, PD-L1 CPS ≥ 1, and total Japanese populations.
resultsIn Japan, 67 patients were enrolled (pembrolizumab, n = 23; pembrolizumab-chemotherapy, n = 25; EXTREME, n = 19). Median follow-up was 71.0 months (range, 61.2-81.5); data cutoff, February 21, 2022. 5-year OS rates with pembrolizumab versus EXTREME were 35.7% versus 12.5% (hazard ratio [HR] 0.38; 95% CI 0.13-1.05), 23.8% versus 12.5% (HR 0.70; 95% CI 0.34-1.45), and 30.4% versus 10.5% (HR 0.54; 95% CI 0.27-1.07) in the PD-L1 CPS ≥ 20, CPS ≥ 1, and total Japanese populations, respectively. 5-year OS rates with pembrolizumab-chemotherapy versus EXTREME were 20.0% versus 14.3% (HR 0.79; 95% CI 0.27-2.33), 10.5% versus 14.3% (HR 1.18; 95% CI 0.56-2.48), and 8.0% versus 12.5% (HR 1.11; 95% CI 0.57-2.16) in the PD-L1 CPS ≥ 20, CPS ≥ 1, and total Japanese populations, respectively.
conclusionAfter 5 years of follow-up, pembrolizumab and pembrolizumab-chemotherapy showed long-term clinical benefits; results further support these treatments as first-line options for Japanese patients with R/M HNSCC. CLINICAL
trial registrationNCT02358031.
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