ArticleFrontiers in immunology2026
Prediction of clinical outcomes of advanced cutaneous squamous cell carcinoma to PD-1 inhibition directly from histopathology slides using inferred transcriptomics.
Article in Frontiers in immunology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Introduction: Metastatic or locally advanced cutaneous squamous cell carcinoma (cSCC) that is not amenable to local therapy is treated with programmed death-1 (PD-1) inhibitors. Although response rates are relatively high, there are no validated predictive biomarkers to guide treatment. As a result, a subset of patients - particularly frail and elderly patients which can be treated with local palliative therapy - are exposed to immune-related adverse events without clinical benefit. Here, we present a retrospective evaluation of ENLIGHT-DP, a novel digital pathology biomarker which predicts response to PD-1 inhibition in advanced cSCC directly from histopathology slides using inferred transcriptomics. Methods: We scanned high-resolution hematoxylin and eosin (H&E) slides from pretreatment tumor samples of 38 patients with advanced cSCC treated with cemiplimab and retrospectively generated an individualized prediction score using the ENLIGHT-DP pipeline in a two-step process: (i) inference of mRNA expression profiles directly from H&E slides using the DeepPT deep-learning algorithm, and (ii) integration of these inferred transcriptomes into ENLIGHT, a transcriptomics-based precision oncology platform that predicts therapeutic response. We unblinded clinical outcomes and assessed the predictive performance of ENLIGHT-DP. Results: The cohort consisted primarily of frail, elderly patients (median age 81 years), with 18 patients having an ECOG performance status ≥2. Using a binary threshold for classification, ENLIGHT-DP significantly predicted response to cemiplimab, demonstrating a positive predictive value of 84.2% and an odds ratio (OR) of 4.8 (95% CI: 1.1-22.1), along with significant stratification for progression-free survival with HR = 0.22 (95% CI: 0.05-0.95, p = 0.023) and outperforming performance status, age and site of cancer. Comparative analyses of inferred immune-related transcriptomic signatures revealed significant differences between cSCC and head and neck squamous cell carcinoma, underscoring distinct tumor immunobiology. Conclusion: This exploratory study introduces ENLIGHT-DP as a digital pathology biomarker shown to significantly predict clinical outcomes in patients with cSCC treated with PD-1 inhibitors.
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