Genialis RNA Biomarker Predicts KRAS Outcomes in Lung Cancer

Today at the American Association for Cancer Research (AACR) 2024 Annual Meeting in San Diego, Genialis, a leading RNA-biomarker company, unveiled their latest AI/ML classifier, Genialis™ krasID. This innovative tool accurately predicts clinical benefit in patients treated with sotorasib, a KRAS inhibitor approved for KRAS G12C non-small cell lung cancers. In addition to presenting findings on the biomarker’s performance in predicting drug response across preclinical models, Genialis also shared insights into its real-world clinical benefits.

Genialis krasID utilizes RNA-sequencing and a sophisticated machine learning algorithm to delve into the fundamental aspects of KRAS biology. This innovative classifier demonstrated remarkable accuracy in predicting preclinical drug response, boasting an impressive Area Under the Receiver Operator Curve (AUROC) of 0.94. Moreover, it effectively identified real-world patient responders with an AUROC of 0.80.

In-depth analysis of real-world sotorasib patient data revealed significant insights. Patients classified as “krasID-high” exhibited a median time on treatment of nearly one year (338 days), compared to only 158 days for those classified as “krasID-low” (hazard ratio [HR] = 0.35). These findings underscore the potential of the Genialis krasID classifier to forecast response and stratify durable benefit across experimental and clinical settings.

Mark Uhlik, Vice President of Biomarker Development at Genialis, emphasized the biomarker’s versatility across drug development and clinical care. By integrating intrinsic and extrinsic biologies inherent to KRAS function, krasID is poised to excel across diverse drugs and disease settings.

KRAS mutations are widespread in various cancers, but current biomarkers often fall short in predicting or monitoring response. Genialis krasID, utilizing high-dimensional gene expression data, captures the intricate biological complexity unique to each patient, offering a more comprehensive diagnostic tool.

Rafael Rosengarten, PhD, CEO of Genialis, highlighted the urgent need for more informative diagnostic tests, particularly for patients with KRAS-driven cancers. Genialis krasID aims to provide a comprehensive understanding of these diseases, guiding personalized treatment strategies.

The AACR launch also marks the initiation of an early access program (EAP) for Genialis krasID, with over 50 biopharma companies developing numerous KRAS-targeted drugs across various disease indications. With commitments from several prominent partners, Genialis anticipates a full commercial launch of krasID in September, revolutionizing KRAS-targeted patient care.

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