CNSide’s FORESEE Trial Demonstrates Enhanced Detection And Treatment For Leptomeningeal Metastases In Cancer Patients

CNSide Diagnostics, a subsidiary of Plus Therapeutics, Inc., is set to present findings from the FORESEE trial at the Society for Neuro-Oncology (SNO) Annual Meeting in November 2024, from 21-24 in Houston, Texas. The trial highlights the CNSide CSF Assay Platform's effectiveness in diagnosing and guiding treatment for breast cancer and non-small cell lung cancer (NSCLC) patients with leptomeningeal metastases (LM).

Marc H. Hedrick, M.D., Plus Therapeutics’ President and Chief Executive Officer, “Current gold standard CSF cytology lacks the sensitivity needed to reliably diagnose LM in most clinical situations and lacks utility for disease monitoring. 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 results include:

• CNSide passed its primary endpoint by influencing treatment decisions in over 90% of evaluated cases, exceeding the 20% target.

• The assay demonstrated 80% sensitivity in detecting tumour cells compared to CSF cytology was 29%.

• Actionable mutations, such as HER2 amplification, were identified in 24% of cases, aiding therapeutic choices.

• CNSide showed high specificity, detecting no tumour cells in patients without LM.

• It improved the negative predictive value for ruling out LM (25%) versus CSF cytology (10%).

• The platform also revealed HER2 positivity in LM tumours in 60% of breast cancer patients with HER2-negative primary tumours, influencing treatment strategies.

The data will be shared on Sunday, November 24, at 10:15 a.m. CST by Dr Priya Kumthekar, an Associate Professor of Neurology and Hematology/Oncology, and Director of the Brain Metastases Program at Northwestern University, Chicago, Illinois, in a session titled: "CSF Tumor Cell (CSF-TC) Detection, Quantification, and Biomarker Assessment Help in Clinical Management of Breast Cancer and Non-Small Cell Lung Cancer Patients Having Leptomeningeal Disease (FORESEE Study, NCT-5414123)."