Lunit Presents Groundbreaking Study on Predicting Treatment Response by HER2 Analysis in Colorectal Cancer

– Collaborative study with NCCHE shows that AI analysis of HER2 expression and the tumor microenvironment is linked to treatment response of Pertuzumab+Trastuzumab in colorectal cancer

SEOUL, South Korea, Aug. 1, 2023 /PRNewswire/ — Lunit (KRX:328130.KQ), a leading provider of AI-powered solutions for cancer diagnostics and therapeutics, today announced the presentation of a groundbreaking study at the ASCO (American Society of Clinical Oncology) Breakthrough conference, to be held from August 3 to August 5 in Yokohama, Japan.

Co-led by Lunit and Dr. Takayuki Yoshino from the National Cancer Center Hospital East (NCCHE), the study reveals a significant breakthrough in understanding the relationship between the HER2 (Human Epidermal growth factor Receptor 2) detailed expression profile analyzed by AI, and treatment response to Pertuzumab plus Trastuzumab in metastatic colorectal cancer (mCRC) patients. This study showcases the potential of Lunit SCOPE HER2, an AI-powered solution designed to detect HER2 expression profile in detail, to provide valuable insights that can predict treatment response, thereby advancing personalized medicine in mCRC patients.

The study utilized HER2 immunohistochemistry (IHC) and H&E-stained whole-slide images (WSI) from 30 mCRC patients confirmed HER2-positive through tumor tissue or circulating tumor DNA (ctDNA) analysis. Lunit SCOPE HER2 was employed to assess HER2 levels. HER2 intensity was categorized into negative, 1+, 2+, or 3+. The study employed a higher HER2 cutoff (HER2 3+ higher than 50%) than the standards used in breast and gastric cancers (HER2 3+ higher than 10%).

The findings demonstrated a wide variation in the proportion of HER2 3+ tumor cells among the samples assessed by pathologists. Objective response rates (ORR) for Pertuzumab plus Trastuzumab treatment in the entire patient group and the HER2 IHC 3+ patient subgroup assessed by pathologists were 26.7% and 34.8%, respectively. Importantly, Lunit SCOPE HER2 identified that the >50% HER2 3+ patient subgroup had an ORR of 42.1%, which contained all 8 responding patients. Consistent with the above, there were no responders in the subgroup of HER2 3+ 10%-49% or <10%. Moreover, patients with HER2 3+ ≥ 50% demonstrated clinically significant improvement in progression-free survival (PFS) and overall survival (OS) compared to those with HER2 3+ < 50%.

“This remarkable research will be the beginning of a revolution that AI technology will bring to cancer medicine,” said Dr. Takayuki Yoshino of the National Cancer Center Hospital East (Kashiwa, Chiba), principal investigator of the SCRUM-Japan MONSTAR-SCREEN project. “This finding has the potential to bring more appropriate treatment to patients, leading to further personalized medicine. We are pleased that Lunit’s cutting-edge AI-based diagnostic technology and our project leading the development of therapies will work together to bring a new approach to cancer treatment.”

“This groundbreaking study marks a significant milestone for Lunit and reinforces our commitment to advancing personalized medicine in cancer treatment,” said Brandon Suh, CEO of Lunit. “The findings from this study demonstrate the potential of Lunit SCOPE HER2 to provide valuable insights in predicting treatment response for HER2-positive metastatic colorectal cancer patients. We are excited about the possibilities of using AI-powered solutions to improve treatment decisions and patient outcomes across a broad range of cancer types.”

This study demonstrates for the first time that the further stratification of HER2 3+ CRC patients by HER2 expression via Lunit SCOPE HER2 has predictive implications for the efficacy of a HER2-targeted therapeutic. Lunit’s ongoing research in collaboration with NCCHE and other partners aims to develop this paradigm of HER2 continuous expression as a predictor for HER2-targeted therapeutics such as monoclonal antibodies and antibody-drug conjugates (ADC).

About Lunit

Lunit is a deep learning-based medical AI company on a mission to conquer cancer. Our focus is on developing AI solutions for precision diagnostics and therapeutics, ensuring the right diagnosis, and treatment, at the right cost for each patient. Lunit is devoted to developing advanced medical image analytics and AI-based biomarkers via cutting-edge technology.

Founded in 2013, Lunit has been acknowledged around the world for its advanced, state-of-the-art technology and its application in medical images. Its technology has been recognized at international AI competitions surpassing giants like Google, IBM, and Microsoft. As a medical AI company grounded on clinical evidence, the company’s findings are presented in major peer-reviewed journals such as the Journal of Clinical Oncology and JAMA Network Open, and global conferences including ASCO and AACR.

After receiving FDA clearance and the CE Mark, our flagship Lunit INSIGHT suite is clinically used in approximately 2,000 hospitals and medical institutions across 40+ countries. Lunit is headquartered in Seoul, South Korea with offices and representatives worldwide. For more information, please visit

About Lunit SCOPE

Lunit SCOPE is a suite of AI-powered software that analyzes tissue slide images for digital pathology and AI biomarker development, aiming to optimize workflow and facilitate more accurate and predictive clinical data for clinicians and researchers.

Lunit SCOPE platform offers multiple tissue analysis AI software products and assays that can streamline digital pathology workflow and diagnostics and enhance the drug development process.

Lunit SCOPE IO analyzes the tumor microenvironment (TME) based on H&E analysis and provides AI-based predictive clinical outcome information. In addition, AI-driven Immunohistochemistry (IHC) slide analysis services are offered, through products such as Lunit SCOPE PD-L1, Lunit SCOPE HER2, Lunit SCOPE ER/PR, and others.