Presentation (CTI)

OBJECTIVES: Precision oncology focuses on specific subpopulations characterized by distinct biomarker expression. Guidelines recommend testing for biomarkers that specifically inform treatment choices. Implementation of testing guidelines in clinical practice is often slow to scale. Emerging biomarkers (crucial for new and future treatments) may be under-tested and consequently under-reported in real-world data, creating evidence gaps. This research describes how testing of archival biosamples across 10 indications, using IQVIA’s Oncology Evidence Network, provides robust biomarker insights and addresses these evidence gaps for Health Technology Assessments and regulatory submissions.
METHODS: Sites with extensive biobanks and pathology services enabled access to biosamples from patients’ archival tissue or blood samples, advanced testing facilities, and comprehensive EMR data. These were used to construct clinically rich study datasets for specific cohorts defined by the emerging biomarker of interest for a specific study. Details are provided on the set-up used to generate two different cohorts of patients retrospectively tested for two specific biomarkers.
RESULTS: Tumor biopsy or blood samples were available for testing at 24 sites across 7 European countries and the US. Excluding samples of insufficient quality, tests were performed for 508 patients (additional patients are still planned to be tested): 89 samples (microdissection slides) were shipped by 2 sites to a central lab for testing, 419 samples were tested locally by 22 sites. Established assays appropriate to each biomarker were used in each of the studies: immunohistochemistry, next generation sequencing and quantitative real-time polymerase chain reaction.
CONCLUSIONS: Our approach provides a robust solution for generating high-quality real-world biomarker insights as an alternative to burden some prospective sample collection studies, but requires precise and complex coordination between multiple sites, data linkage, and well-defined biomarker testing standards. Retrospective testing studies can meet the needs of upcoming therapy launches targeting novel biomarkers (e.g. lung, prostate, urothelial carcinoma, or gastrointestinal cancers).