Press release summary
An exploratory analysis using Lunit’s digital pathology software found that quantitative HER2 expression was associated with treatment response in a small study of advanced biliary tract cancer. The findings were reported Oct. 14 in connection with the multicenter HERBOT phase 1b/2 trial, which enrolled 40 patients at 12 sites in South Korea and was published in Nature Medicine.
Patients received trastuzumab, nivolumab, gemcitabine and cisplatin. The trial reported a 55% objective response rate and median progression-free survival of 10.6 months. Lunit SCOPE HER2 analyzed whole-slide images to measure the proportion of tumor cells with HER2 3+ staining. Among patients with at least 10% HER2 3+ cells, the reported response rate was 80%, compared with 40% below that threshold. The difference was statistically significant in the exploratory analysis. Conventional grouping of IHC 3+ cases versus IHC 2+/ISH-positive cases did not show a statistically significant response difference.
For clinical laboratory and pathology readers, the study illustrates how continuous image-derived measurements may add information beyond categorical biomarker calls. It does not establish a new clinical cutoff or demonstrate that the software improves patient outcomes. The cohort was small, the analysis was exploratory and Lunit SCOPE is described as research use only. Larger prospective validation, assay standardization and regulatory review would be needed before the approach could guide routine treatment decisions.
Leave a Reply