Lunit announced the presentation of a study at the ASCO (American Society of Clinical Oncology) Breakthrough conference, to be held from August 3 to August 5, 2023 in Yokohama, Japan. 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 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).