Lunit "Phase 3 Results of AI-Driven Non-Small Cell Lung Cancer Mutation Published in International Journal"

International Oncology Journal JCO Publication
Maximizing Effectiveness Using 'Lunit Scope IO'
Selected as Latest Clinical Research at ESMO 2023

Medical AI company Lunit announced on the 24th that the results of applying AI-based 'Lunit Scope' as an exploratory biomarker in a Phase 3 clinical trial of immuno-chemotherapy combination therapy for non-small cell lung cancer (NSCLC) patients with genetic mutations have been published in the international oncology journal JCO (Journal of Clinical Oncology).

Lunit's Artificial Intelligence (AI) Biomarker 'Lunit Scope IO'
[Photo by Lunit]

Lunit emphasized that this study is noteworthy for maximizing research efficacy by using Lunit Scope as an additional exploratory biomarker analysis in the clinical trial. JCO is an international journal published by the American Society of Clinical Oncology (ASCO) with a global impact factor of 50.739. Following last year, Lunit has again published the latest research related to AI biomarkers in JCO this year.

The research team demonstrated the clinical efficacy of combination therapy using immune checkpoint inhibitors such as atezolizumab and bevacizumab along with chemotherapy in NSCLC patients harboring epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) mutations. Generally, targeted therapies show strong effects in NSCLC patients with EGFR and ALK mutations, whereas the efficacy of immune checkpoint inhibitors is known to be limited. However, targeted therapies eventually develop resistance over time, increasing the demand for treatment options utilizing immune checkpoint inhibitors.

Regarding this unmet need, previous studies on immuno-chemotherapy combination therapies were conducted mainly by global major pharmaceutical companies but yielded no visible results. Therefore, Lunit explained that this study is significant as a Phase 3 clinical trial demonstrating the clinical efficacy of immuno-chemotherapy combination therapy using immune checkpoint inhibitors in NSCLC patients with EGFR and ALK mutations undergoing targeted therapy.

In this study, the research team led by Professors Myung-Joo Ahn and Se-Hoon Park from the Department of Hematology and Oncology at Samsung Medical Center randomized a total of 228 patients, including 215 with EGFR mutations and 13 with ALK mutations, from 16 medical institutions in Korea at a 2:1 ratio. Additionally, Lunit Scope was utilized to predict the prognosis of immune checkpoint inhibitors by analyzing the spatial distribution of tumor-infiltrating lymphocytes (TILs), which are immune cells, within tumor tissues and evaluating immune phenotypes.

The research team divided the patients into two groups: one received combination therapy with atezolizumab, bevacizumab, paclitaxel, and carboplatin (ABCP treatment group), and the other received combination therapy with pemetrexed and carboplatin or cisplatin (PC treatment group). The clinical efficacy was then compared. As a result, the median progression-free survival (mPFS), which is the primary endpoint indicating the duration patients survive without cancer progression or worsening, was significantly longer in the ABCP treatment group at 8.48 months compared to 5.62 months in the PC treatment group. The objective response rate (ORR), which refers to the proportion of patients whose tumors shrink or disappear completely after drug administration, was higher in the ABCP treatment group at 69.5% compared to 41.9% in the PC treatment group.

Furthermore, the research team applied Lunit Scope IO to evaluate immune phenotypes (IP) based on the distribution of tumor-infiltrating lymphocytes (TILs). The progression-free survival (PFS) in the group with TIL expression of 20% or less was 8.28 months for the ABCP treatment group and 6.93 months for the PC treatment group, showing little difference. In contrast, the PFS in the group with TIL expression of 20% or more was 12.91 months for the ABCP treatment group and 4.86 months for the PC treatment group, showing a significant difference.

Lunit emphasized that these results demonstrate that applying Lunit Scope allows precise interpretation of immune activation status based on TIL distribution, which can provide useful information for selecting patient groups that can achieve significant clinical benefits when immune checkpoint inhibitors are combined with existing anticancer therapies.

Seobum Seok, CEO of Lunit, stated, "This study was selected as a 'Late-breaking Abstract' at the recently held European Society for Medical Oncology (ESMO), one of the world's top three cancer conferences, attracting attention from academia and industry regarding AI biomarkers." He added, "Especially since this study is a clinical trial that global major pharmaceutical companies have repeatedly failed in the past, we expect that further research and collaborative activities such as developing companion diagnostic models with global pharmaceutical companies to obtain approval from the U.S. Food and Drug Administration (FDA) will become more active."

This content was produced with the assistance of AI translation services.