ArticleThe Lancet regional health. Europe2024
Cemiplimab in locally advanced or metastatic cutaneous squamous cell carcinoma: prospective real-world data from the DRUG Access Protocol.
Article in The Lancet regional health. Europe, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 1 of them a synthesis 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
14 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Efficacy of Neoadjuvant Cemiplimab Treatment for Cutaneous Squamous Cell Carcinoma-A Systematic Review.International journal of molecular sciences · 2025Pooled it
- Conversion-intent PD-1-based chemoimmunotherapy restores surgical feasibility in borderline resectable or unresectable non-head-and-neck cutaneous squamous cell carcinoma.The oncologist · 2026Article
- A Real-World Experience of Cemiplimab in Patients with Advanced Cutaneous Squamous Cell Carcinoma.Cancers · 2026Article
- Stakeholders' experiences with a clinician-led access programme linking evidence generation and reimbursement for precision cancer treatments: the drug access protocol in the Netherlands.Acta oncologica (Stockholm, Sweden) · 2026Article
- Novel Immunotherapeutic Approaches for Patients with Head and Neck Cutaneous Squamous Cell Carcinoma.Oncology research · 2026Review
- HLX07, a novel anti-EGFR antibody, for locally advanced and metastatic cutaneous squamous cell carcinoma: an open-label, multicenter, phase II trial.Therapeutic advances in medical oncology · 2026Article
- Advanced Cutaneous Squamous Cell Carcinoma: Biology, Immunotherapy, and Evolving Prognostic Factors.Biomedicines · 2025Review
- Longitudinal data on advanced cutaneous squamous cell carcinoma from the Dutch Keratinocyte Cancer Collaborative (DKCC): a nationwide real-world database study.The Lancet regional health. Europe · 2025Article
- Article
- Peri-Implant Oral Squamous Cell Carcinoma (OSCC): Clinicopathological Features and Staging Issues.Cancers · 2025Article
- Exposed Necrotic Bone in a Head and Neck Cancer Patient: Report of a Diagnostic Challenge.Diagnostics (Basel, Switzerland) · 2025Article
- Article
- Clinical and histopathological features of advanced cutaneous squamous cell carcinoma with varying responses to cemiplimab.Journal der Deutschen Dermatologischen Gesellschaft = Journal of the German Society of Dermatology : JDDG · 2025Article
- From actinic keratosis to cutaneous squamous cell carcinoma: the key pathogenesis and treatments.Frontiers in immunology · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
17 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background: The DRUG Access Protocol provides patients with cancer access to registered anti-cancer drugs that are awaiting reimbursement in the Netherlands and simultaneously collects prospective real-world data (RWD). Here, we present RWD from PD-1 blocker cemiplimab in patients with locally advanced or metastatic cutaneous squamous cell carcinoma (laCSCC; mCSCC). Methods: Patients with laCSCC or mCSCC received cemiplimab 350 mg fixed dose every three weeks. Primary endpoints were objective clinical benefit rate (CBR), defined as objective response (OR) or stable disease (SD) at 16 weeks, physician-assessed CBR, defined as clinician's documentation of improved disease or SD based on evaluation of all available clinical parameters at 16 weeks, objective response rate (ORR), and safety, defined as grade ≥ 3 treatment related adverse events (TRAEs) occurring up to 30 days after last drug administration. Secondary endpoints included duration of response (DoR), progression-free survival (PFS), and overall survival (OS). Findings: Between February 2021 and December 2022, 151 patients started treatment. Objective and physician-assessed CBR were 54.3% (95% CI, 46.0-62.4) and 59.6% (95% CI, 51.3-67.5), respectively. ORR was 35.1% (95% CI, 27.5-43.3). After a median follow-up of 15.2 months, median DoR was not reached. Median PFS and OS were 12.2 (95% CI, 7.0-not reached) and 24.2 months (95% CI, 18.8-not reached), respectively. Sixty-eight TRAEs occurred in 29.8% of patients. Most commonly reported TRAE was a kidney transplant rejection (9.5%). Interpretation: Cemiplimab proved highly effective and safe in this real-world cohort of patients with laCSCC or mCSCC, confirming its therapeutic value in the treatment of advanced CSCC in daily clinical practice. Funding: The DRUG Access Protocol is supported by all participating pharmaceutical companies: Bayer, Janssen, Lilly, Merck, Novartis, Roche, and Sanofi.
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.