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All Times EDT

Wednesday, September 21
Wed, Sep 21, 4:15 PM - 5:30 PM
Salon C
Finding the Needle in the Haystack: Statistical Challenges in Using CtDNA as a Meaningful Endpoint in Regulatory Decision-Making

Driver Mutation Variant Allele Frequency (VAF) in Circulating Tumor DNA and Association with Clinical Outcome in NSCLC Patients with EGFR- and KRAS-Mutated Tumors (304744)

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*Meijuan Li, Eisai Oncology  

Keywords: VAF, ctDNA, driver mutation, Overall Survival time, real world evidence data

Clinical implementation of mutational analysis for NGS-based assays has largely been of a binary nature with pathogenic mutations being reported as either positive or negative. Actionability on the continuous output of variant allele frequency (VAF) has not been well characterized in the clinical setting, limiting its use. In this talk, the association of allele frequency of clinically relevant short variants in circulating free DNA (cfDNA) with overall survival (OS) for patients using real-world data was also assessed. The results of the association analysis indicated that VAF of the predictive biomarker mutation negatively correlated with OS of NSCLC patients who were under different treatment option. The results from this study may support ctDNA a potential surrogate endpoint of the clinical outcome.