Methylation biomarkers for osimertinib treatment management

An epigenetic detection platform and clinical database analyze NSCLC patients' epigenetic landscape to identify non-genetic resistance mechanisms, addressing osimertinib resistance by characterizing methylation biomarkers, thereby improving treatment strategies.

WO2026050287A1 Publication Date: 2026-03-05GUARDANT HEALTH INC
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Patent Information

Application Number
PCT/US2025/043587
Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
Priority Date
2024-11-14
Filing Date
2025-08-26
Publication Date
2026-03-05

AI Technical Summary

Technical Problem

Current treatments for non-small cell lung cancer (NSCLC) using osimertinib face significant resistance due to non-genetic factors, particularly epigenetic modifications, which are not adequately addressed by existing somatic next-generation sequencing methods, accounting for only 40-45% of resistance cases.

Method used

An epigenetic detection platform and clinical database are used to analyze the epigenetic landscape of NSCLC patients, identifying epigenetic differences and non-genetic mechanisms of resistance through methylation biomarkers, employing a method that includes detecting methylation at specific sites, generating metrics, and building a classification model to characterize samples.

Benefits of technology

This approach identifies potential non-genetic mechanisms of osimertinib resistance, enhancing the understanding of treatment resistance and improving personalized treatment strategies by characterizing the epigenetic landscape of NSCLC patients.

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Abstract

Described herein are methods and compositions related to methylation-based determination and characterization of subjects afflicted with various stages of cancer, including lung cancer and non-small cell lung cancer (NSCLC). Osimertinib is one of the most common precision therapies in non-small cell lung cancer but nearly all patients eventually progress due to somatic mutations and cellular plasticity that bypass the treatment. Defining the cellular plasticity state with epigenetics will help physicians know when to switch therapies.
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