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Plus Therapeutics to Present Positive FORESEE Clinical Trial Summary Demonstrating Utility of CNSide™ Cerebrospinal Fluid Assay in Diagnosis and Clinical Management of Patients with Leptomeningeal Metastases
Prospective FORESEE trial of CNSide Cerebrospinal Fluid (CSF) Assay met key primary and secondary endpoints CNSide CSF Assay influenced clinical management
About this update from Plus Therapeutics, Inc.
[{"type":"text","content":"Prospective FORESEE trial of CNSide Cerebrospinal Fluid (CSF) Assay met key primary and secondary endpoints CNSide CSF Assay influenced clinical management decisions in over 90% of leptomeningeal metastases (LM) cases Assay demonstrated 2.8 times the diagnostic sensitivity vs. standard cytology AUSTIN, Texas, Nov. 22, 2024 (GLOBE NEWSWIRE) -- CNSide Diagnostics, LLC, a wholly owned subsidiary of Plus Therapeutics, Inc. (Nasdaq: PSTV) (“Plus” or the “Company”), will present data from the FORESEE trial showcasing the CNSide CSF Assay Platform’s utility in diagnosing and guiding clinical decision making for breast cancer and non-small cell lung cancer patients with LM. The data will be presented at the 2024 Society for Neuro-Oncology (SNO) Annual Meeting November 21-24 in Houston, Texas. “Current gold standard CSF cytology lacks the sensitivity needed to reliably diagnose LM in most clinical situations and lacks utility for disease monitoring,” said Marc H. Hedrick, M.D., Plus Therapeutics’ President and Chief Executive Officer. “The FORESEE trial shows that CNSide may be a useful tool in accurately identifying all patients with LM, ruling out patients at risk, and enhancing the disease management and monitoring of LM.” Key highlights: The FORESEE trial achieved its primary endpoint, demonstrating that CNSide influenced treatment decisions in over 90% of cases evaluated, surpassing the predetermined 20% primary endpoint targetCNSide demonstrated enhanced sensitivity in detecting tumor cells (80%) vs. CSF cytology (29%) in patients with LMCNSide identified actionable mutations in the CSF, such as HER2 amplification, influencing 24% of therapeutic selection decisionsCNSide exhibited high specificity, with no tumor cells detected in patients without LMCNSide demonstrated improved Negative Predictive Value in ruling out LM (25%) vs. CSF cytology (10%)CNSide revealed HER2 positivity in LM tumors in 60% of breast cancer patients with HER2-negative primary tumors, informing physician treatment strategies The data will be presented on Sunday, November 24, at 10:15 a.m. CST in a session titled, “CSF Tumor Cell (CSF-TC) Detection, Quantification and Biomarker assessment Helps in Clinical Management of Breast Cancer and Non-Small Cell Lung Cancer Patients Having Leptomeningeal Disease (FORESEE Study, NCT-5414123),” by Priya Kumthekar, M.D., A...