Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2023
Pembrolizumab With or Without Chemotherapy in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma: Updated Results of the Phase III KEYNOTE-048 Study.
Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 319 papers, 9 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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.
Neoadjuvant Chemoimmunotherapy With or Without SBRT Followed by Surgery for Locoregionally Advanced Squamous Cell Carcinoma of the Oral Cavity and Oropharynx: A Phase II Randomized Trial
Head and Neck Advanced Research for Multi-Omics and Optimized Immunotherapy(HARMONI)
Who cites it
319 citing papers in PubMed, 9 syntheses or guidelines pooled it, 450 citations in OpenAlex.
- Two-year follow-up outcomes of neoadjuvant therapy in oral squamous cell carcinoma: an exploratory systematic review and meta-analysis.BMC oral health · 2026Pooled it
- Advancements in immunotherapy for oropharyngeal cancer: Current landscape and future prospects.Biomedical papers of the Medical Faculty of the University Palacky, Olomouc, Czechoslovakia · 2026Pooled it
- Efficacy of first-line immune checkpoint inhibitors for recurrent/metastatic head and neck cancer: a systematic review and meta-analysis.Immunotherapy · 2026Pooled it
- Efficacy and safety of immunotherapy in head and neck tumors: a systematic review and meta-analysis of clinical outcomes and survival benefits.Frontiers in oncology · 2026Pooled it
- Immunotherapy plus targeted therapy for recurrent or metastatic head and neck squamous cell carcinoma: an updated meta-analysis and subgroup analysis by target mechanism.Frontiers in oncology · 2026Pooled it
- Second-event endpoints (EFS2, PRFS2 and PFS2) after anti-PD-(L)1-based RCTs: a systematic review and meta-analysis.Journal for immunotherapy of cancer · 2025Pooled it
- Efficacy and safety of pembrolizumab in the treatment of advanced hepatocellular carcinoma: a systematic review and meta-analysis.European journal of clinical pharmacology · 2025Pooled it
- Evidence-based guideline diagnosis, treatment, prevention and aftercare of oropharyngeal and hypopharyngeal carcinoma.German medical science : GMS e-journal · 2025Guideline
- Efficacy of Immune Checkpoint Inhibitors in the Treatment for Head and Neck Cancer Patients: A Systematic Review and Network Meta-Analysis.Oncology research · 2025Pooled it
- Pembrolizumab-Chemotherapy Versus Pembrolizumab in Head and Neck Squamous Cell Carcinoma: A PD-L1 CPS-Stratified Analysis of Updated KEYNOTE-048 Data.International journal of cancer · 2026Trial
- OPTIM: a randomized phase II trial of nivolumab followed by nivolumab-ipilimumab or docetaxel at progression in recurrent/metastatic squamous cell carcinoma of the head and neck (OPTIM; AIO-KHT-0117).British journal of cancer · 2026Trial
- Enfortumab Vedotin plus Pembrolizumab as First-line Treatment in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma: Results from EV-202 Cohort 9.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026Trial
- Efficacy and safety of toripalimab in combination with cetuximab in patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC): a phase 1b/2 study.Signal transduction and targeted therapy · 2026Trial
- Pembrolizumab combined with nab-paclitaxel and platinum in recurrent/metastatic HNSCC: efficacy, safety, and survival predictive model.ESMO open · 2026Trial
- Camrelizumab Plus Famitinib in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma: A Phase 2 Study.Cancer medicine · 2026Trial
- Stereotactic Body Radiation Therapy With Pembrolizumab in Programmed Cell Death Protein 1 Inhibitor-Refractory Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma: A Phase 2 Trial.International journal of radiation oncology, biology, physics · 2026Trial
- Modified EXTREME regimen versus modified TPEx regimen as first-line treatment for recurrent or metastatic head and neck squamous cell carcinoma: a multicenter, open-label, randomized, exploratory study (TEMPER study).International journal of clinical oncology · 2026Trial
- Evaluation of Neutrophil to Lymphocyte Ratio in Patients With Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma Treated With a Combination of Cetuximab and Nivolumab in a Phase II Clinical Trial.American journal of clinical oncology · 2026Trial
- Trial
- Phase II study of magrolimab combination therapies in patients with head and neck squamous-cell carcinoma.ESMO open · 2026Trial
259 more citing papers are in PubMed but not listed here.
Corrections and comments
- Commented on by
Authors and funding
21 authors at 17 institutions in 13 countries.
Funding
Abstract
purposePembrolizumab and pembrolizumab-chemotherapy demonstrated efficacy in recurrent/metastatic head and neck squamous cell carcinoma in KEYNOTE-048. Post hoc analysis of long-term efficacy and progression-free survival on next-line therapy (PFS2) is presented.
methodsPatients were randomly assigned (1:1:1) to pembrolizumab, pembrolizumab-chemotherapy, or cetuximab-chemotherapy. Efficacy was evaluated in programmed death ligand 1 (PD-L1) combined positive score (CPS) ≥ 20, CPS ≥ 1, and total populations, with no multiplicity or alpha adjustment.
resultsThe median study follow-up was 45.0 months (interquartile range, 41.0-49.2; n = 882). At data cutoff (February 18, 2020), overall survival improved with pembrolizumab in the PD-L1 CPS ≥ 20 (hazard ratio [HR], 0.61; 95% CI, 0.46 to 0.81) and CPS ≥ 1 populations (HR, 0.74; 95% CI, 0.61 to 0.89) and was noninferior in the total population (HR, 0.81; 95% CI, 0.68 to 0.97). Overall survival improved with pembrolizumab-chemotherapy in the PD-L1 CPS ≥ 20 (HR, 0.62; 95% CI, 0.46 to 0.84), CPS ≥ 1 (HR, 0.64; 95% CI, 0.53 to 0.78), and total (HR, 0.71; 95% CI, 0.59 to 0.85) populations. The objective response rate on second-course pembrolizumab was 27.3% (3 of 11). PFS2 improved with pembrolizumab in the PD-L1 CPS ≥ 20 (HR, 0.64; 95% CI, 0.48 to 0.84) and CPS ≥ 1 (HR, 0.79; 95% CI, 0.66 to 0.95) populations and with pembrolizumab-chemotherapy in the PD-L1 CPS ≥ 20 (HR, 0.64; 95% CI, 0.48 to 0.86), CPS ≥ 1 (HR, 0.66; 95% CI, 0.55 to 0.81), and total (HR, 0.73; 95% CI, 0.61 to 0.88) populations. PFS2 was similar after pembrolizumab and longer after pembrolizumab-chemotherapy on next-line taxanes and shorter after pembrolizumab and similar after pembrolizumab-chemotherapy on next-line nontaxanes.
conclusionWith a 4-year follow-up, first-line pembrolizumab and pembrolizumab-chemotherapy continued to demonstrate survival benefit versus cetuximab-chemotherapy in recurrent/metastatic head and neck squamous cell carcinoma. Patients responded well to subsequent treatment after pembrolizumab-based therapy.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.