BOSTON & SAN DIEGO--(BUSINESS WIRE)--Genialis, the RNA-biomarker company, today presented a poster on a new AI/ML classifier, Genialis™ krasID, that accurately predicts clinical benefit in a real-world cohort of patients who received sotorasib, a KRAS inhibitor currently approved for KRAS G12C non-small cell lung cancers. Genialis presented additional findings on the performance of the biomarker in predicting drug response across preclinical models and real-world clinical benefit at the American Association for Cancer Research (AACR) 2024 Annual Meeting in San Diego on April 5-10, 2024.
Genialis krasID analyzes foundational aspects of KRAS biology using RNA-sequencing and a machine learning algorithm comprising numerous biologic signatures. The classifier predicted preclinical drug response with an accuracy of 0.94 Area Under the Receiver Operator Curve (AUROC) and correctly selected real-world patient responders with an AUROC of 0.80. Kaplan-Meier analysis of the real-world sotorasib patient data considered time on treatment as an available proxy for progression-free survival. This analysis showed that patients classified as “krasID-high” had median time on treatment of almost one year (338 days), compared with those classified as “krasID-low” with median time on treatment of only 158 days (hazard ratio [HR] = 0.35). Taken together, these early results demonstrate that the Genialis krasID classifier can predict response and stratify durable benefit in experimental and clinical settings.
“Genialis krasID is designed to support the entire lifecycle of drug development and clinical care. Because the model incorporates biologies that are intrinsic to KRAS function in the tumor and extrinsic to the surrounding tumor milieu, we expect this biomarker to perform well for diverse drugs across disease settings and mutation status,” said Mark Uhlik, Vice President of Biomarker Development at Genialis.
KRAS mutations are prevalent in many common oncologic malignancies, including lung, colorectal, and pancreatic cancers, with frequencies ranging from 25 percent in NSCLC to nearly 95 percent in pancreatic. Even with two FDA approvals of KRAS inhibitors, the rate of patient response (~30-40%) and the durability of responses (~10-11 months) leaves room for improvement. Most biomarkers in the KRAS space measure only KRAS mutation status, which may be necessary to receive the drug but is insufficient to predict or monitor response or to inform further therapeutic interventions. By using high-dimensional gene expression data, Genialis krasID captures underlying biological complexity unique to each individual patient.
“Genialis recognizes an urgent need for patients with lung, colorectal and pancreatic cancers to have access to more informative diagnostic tests that steer them to the best possible medicines for their disease,” said Rafael Rosengarten, PhD, CEO of Genialis. “We’re just at the dawn of being able to treat KRAS-driven cancers. With Genialis krasID, we can provide the most complete picture of the diseases we’re trying to defeat, and a plan for how to win.”
AACR marks the launch of an early access program (EAP) for Genialis krasID. Over 50 biopharma companies are currently developing more than 70 different KRAS-targeted drugs across over 12 disease indications. The total KRAS therapy market today is estimated at approximately $240 million, with a compound annual growth rate of 36% to reach $10 billion by 2032. Meanwhile, available diagnostics to support KRAS-targeted patient care are limited to mutation-based tests.
Last week, Genialis announced the addition of two new partners as it assembles the world’s most ethnographically diverse cancer data sets. For the new Genialis krasID program, Genialis already has commitments from several marquee partners across biopharma, diagnostics, and clinical research centers and is reserving space to add a handful more of select organizations. Early access program members will gain the opportunity to have their KRAS-related data analyzed by Genialis to establish a foundation for implementing krasID within their translational and clinical workflows. Genialis anticipates a full commercial launch of the biomarker product in September. For more information on Genialis RNA-biomarker programs, please visit https://www.genialis.com/rna-biomarkers/.
About Genialis
Genialis, the RNA biomarker company, is creating a world where healthcare delivers the best possible outcomes for patients, their families, and their communities. Genialis develops and validates clinically actionable biomarkers informed by the world’s most ethnographically diverse cancer data sets to better predict patient responses and guide treatment decisions for targeted inhibitors, immunotherapies, and other emerging therapeutic classes. Genialis is trusted by pharma and diagnostics partners, and together, we are transforming medicine through data. For more information, please visit www.genialis.com.
