'Predicting Drug Efficacy with AI' Lunit "We Will Expand to ADC Area"

Medical AI company Lunit announced on the 1st that it will attend the American Society of Clinical Oncology (ASCO) Breakthrough 2023 conference held in Yokohama, Japan, from the 3rd to the 5th.

[Photo by Lunit]

At this conference, Lunit plans to present oral and poster presentations on the results of a combination therapy study of trastuzumab (brand name Herceptin) and pertuzumab (Perjeta) for human epidermal growth factor receptor 2 (HER2)-positive metastatic colorectal cancer (mCRC) patients, conducted jointly with the National Cancer Center Hospital East (NCCHE) in Japan.

In this phase 2 combination clinical trial involving 30 HER2-positive colorectal cancer patients, Lunit participated by utilizing its AI-based whole tissue slide image analyzer, ‘Lunit Scope HER2,’ and AI biomarker platform, ‘Lunit Scope IO.’ Generally, HER2 expression is commonly observed in breast and gastric cancer patients but is known to be extremely rare in colorectal cancer patients. This clinical trial was conducted with Investigational New Drug (IND) approval in Japan and is also known to be the first approved HER2-targeted therapy clinical trial in colorectal cancer.

The research team used Lunit Scope HER2 to classify HER2 staining intensity into 1+, 2+, and 3+ levels to detect tumor cells, and analyzed the tumor microenvironment?including tumor-infiltrating lymphocytes (TIL), macrophages, and fibroblasts?using Lunit Scope IO. As a result, the objective response rate (ORR) to the combination therapy among all 30 HER2-positive metastatic colorectal cancer patients was 26.7%, and the response rate among 23 patients classified as HER2 3+ by Lunit Scope HER2 was higher at 34.8%. ORR refers to the level of anticancer treatment effect where tumor size is reduced or completely disappears.

When applying a HER2 3+ distribution value of 50%, which is higher than the existing breast and gastric cancer standard of HER2 3+ 10%, the ORR in this group was 42.1%. Progression-free survival (PFS) and overall survival (OS) in these patient groups were also significantly improved in patients with HER2 3+ 50% or higher. PFS refers to the period during which cancer progression or recurrence does not occur, and OS refers to the total survival time of the patient.

The company explained, "This result demonstrates that the AI-based Lunit Scope HER2 can provide more precise predictions than the existing HER2 immunohistochemistry (IHC) method and treatment response predictions based on positive expression levels." Additionally, the research team proved through Lunit Scope IO’s tumor microenvironment analysis that the density of immune and stromal cells such as TIL, macrophages, and fibroblasts within tumor cells significantly affects the outcomes of combination therapy.

Based on this colorectal cancer study using Lunit Scope HER2, Lunit expects that HER2-targeted therapy research will be activated in other cancer types beyond breast and gastric cancers. Furthermore, with the recent launch of AstraZeneca (AZ) and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan), which is gaining attention as a next-generation anticancer therapy, Lunit plans to continuously expand its research scope to include HER2 antibody-drug conjugates (ADC) and other areas.

Seobum Seok, CEO of Lunit, said, “In the clinical trial of HER2-positive colorectal cancer patients with NCCHE, we confirmed the potential of Lunit Scope HER2 to precisely predict patient treatment responses. Based on these research results, we will proceed with regulatory approval procedures so that Lunit Scope HER2 can be used as a biomarker for trastuzumab-pertuzumab combination therapy for metastatic colorectal cancer treatment in Japan.”