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Preprint finds surrogate endpoints dominate US cancer-drug approvals

A medRxiv analysis of 354 FDA oncology approvals from 2014 through early 2025 found surrogate endpoints had become the dominant primary measure used for approval. The authors also reported different relationships between surrogate-endpoint benefits and overall survival for immunotherapy and non-immunotherapy approvals.

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AI Estimates Tumour Immune Markers from H&E Slides

A bioRxiv preprint describes HistoProfile, an AI model that estimates immune-marker measurements from routine cancer tissue slides. The authors report AUROCs of 0.78–0.89 for distinguishing biomarker-high from biomarker-low tumours.

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Preprint reports aristolochic acid DNA signature in blood and urine

A 12-patient preprint reports that duplex sequencing detected the aristolochic acid-associated SBS22a mutation signature in blood and urine from patients with signature-positive urothelial tumours. The findings are a proof of concept, not yet a validated population screening test.

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Melanoma study links major response to 98% five-year survival

A pooled analysis of 1,038 patients found 86.5% five-year overall survival after neoadjuvant immune checkpoint inhibitors for resectable melanoma. Among patients whose tumours had a major pathological response, estimated five-year survival was 98%.

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Phase 1 trial reports responses to a WRN inhibitor in MSI cancers

In a first-in-human phase 1 trial, the oral WRN inhibitor RO7589831 produced disease control in 74.2% of 66 evaluable patients with MSI cancers, with confirmed partial responses in seven. The study selected two doses for further testing, while tumour biopsies did not provide a conclusive measure of target engagement.

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Plasma Neoepitope Search Hit Limits in a Four-Patient Study

A bioRxiv preprint reports that plasma mass spectrometry could detect some tumor-associated peptides, but neoepitope searches were constrained by limited overlap between cfDNA and tumor mutations and by MS sensitivity. Tissue remained the stronger reference for identifying tumor mutations and neoepitopes.