Trial reportJCO precision oncology2025
Clinical Interchangeability of PD-L1 Immunohistochemistry Assays in First-Line Non-Small Cell Lung Cancer Management With Cemiplimab.
Trial report in JCO precision oncology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03088540 (A Global, Randomised, Phase 3, Open-label Study of REGN2810), which is not on this map. Cited by 1 paper.
What it found
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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.
A Global, Randomised, Phase 3, Open-label Study of REGN2810 (ANTI-PD 1 Antibody) Versus Platinum Based Chemotherapy in First Line Treatment of Patients With Advanced or Metastatic PD L1+Non-small Cell Lung Cancer
Who cites it
1 citing paper in PubMed.
- Efficacy of cemiplimab in biomarker defined subgroups of non-small cell lung cancer: a systematic review and meta-analysis.Journal of thoracic disease · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
16 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeMultiple immunohistochemistry (IHC) assays targeting PD-L1 have been developed independently, and a lack of harmonization creates undue complexity for clinicians who use PD-L1 tests to guide treatment decisions. This novel bridging study demonstrates the clinical interchangeability of two PD-L1 IHC assays in first-line treatment of non-small cell lung cancer (NSCLC) with PD-L1 ≥50%.
methodsIn the phase III EMPOWER-Lung 1 study (ClinicalTrials.gov identifier: NCT03088540), 710 patients were randomly assigned 1:1 to first-line cemiplimab or platinum-doublet chemotherapy for advanced NSCLC with PD-L1 ≥50%, selected by PD-L1 IHC 22C3 pharmDx (Agilent Technologies, Santa Clara, CA).
resultsA total of 871 patient samples were retrospectively tested using the VENTANA PD-L1 (SP263) assay (Roche Diagnostics, Indianapolis, IN), including 481 enrolled patients and 390 patients who did not pass screening (22C3 PD-L1 <50%). Concordance of 22C3 and SP263 was evaluated in 768 patient samples, with an overall percent agreement (concordance) of 88% between the two assays. Overall survival (OS) and progression-free survival (PFS) were estimated in the PD-L1 ≥50% SP263+ population (including the 22C3+/SP263+ and 22C3-/SP263+ subpopulations). In the primary analysis, the clinical efficacy of cemiplimab versus chemotherapy in the 22C3+/SP263+ population (n = 324; OS hazard ratio [HR], 0.52 [95% CI, 0.34 to 0.80]; PFS HR, 0.43 [95% CI, 0.32 to 0.59]) was similar to that in the 22C3+ population (n = 563). A sensitivity analysis of the overall SP263+ population showed consistent results with the primary analysis.
conclusionSimilar efficacy (OS and PFS) was observed with the 22C3+ and SP263+ populations, demonstrating the interchangeability of these PD-L1 IHC assays for selecting patients with PD-L1 ≥50% for first-line cemiplimab monotherapy for advanced NSCLC.
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