Medical AI company Lunit said Sept. 23 that research on HER2-positive biliary tract cancer using its AI biomarker platform Lunit SCOPE has been published in Nature Medicine, a leading medical journal with an impact factor of 52.5.
Biliary tract cancer occurs relatively more frequently in South Korea than in other countries, making research led by Korean medical researchers important, and it has a poor prognosis, with life expectancy of only about a year even with standard treatment. In particular, HER2-positive patients, who account for about 15% of all biliary tract cancer patients, have been reported to have worse outcomes than HER2-negative patients.
The paper reports results from a clinical trial of first-line treatment for HER2-positive advanced biliary tract cancer led by a research team headed by Lee Chung-geun, a professor at Yonsei University College of Medicine. Lunit researchers were co-authors and conducted AI-based whole-slide image analysis and biomarker analysis. The study was previously presented as a rapid oral presentation at the 2026 American Society of Clinical Oncology (ASCO 2026) annual meeting.
The research team evaluated a treatment regimen in 40 patients that added the HER2-targeted drug Herceptin (trastuzumab) to standard first-line chemotherapy with gemcitabine and cisplatin combined with the immunotherapy Opdivo (nivolumab). The overall objective response rate (ORR) was 55%, while progression-free survival (PFS) was 10.6 months.
Lunit used Lunit SCOPE HER2 to precisely analyze HER2 expression patterns in patients’ whole-slide images (WSIs), while Lunit SCOPE IO classified patients’ immune phenotypes into three categories — immune-active, immune-excluded and immune-desert — and examined their association with treatment response.
The analysis found an association between the proportion of HER2-overexpressing tumor cells and the degree of tumor reduction after treatment. In addition, patients with an immune-excluded phenotype, who had previously shown limited benefit from immunotherapy, had longer progression-free survival than patients with an immune-desert phenotype when targeted therapy was added.
Lunit CEO Seo Beom-seok said, “The achievement of Lunit SCOPE contributing to research into biliary tract cancer, where treatment options are limited, has been published in a globally renowned academic journal. We will remain focused on establishing Lunit SCOPE as a platform that provides evidence for decision-making ranging from patient selection and clinical trial design to drug development.”
Lunit, founded in 2013, is a medical AI company developing solutions that use AI to support cancer diagnosis and treatment. Its main products include Lunit INSIGHT, an image analysis solution that assists in cancer diagnosis, and Lunit SCOPE, which analyzes tumor tissue to support biomarker discovery and prediction of treatment response.