Plus Therapeutics Reveals Positive Trial Results at 2024 SNO/ASCO CNS Conference

Plus Therapeutics, a clinical-stage pharmaceutical company, has announced promising results from its FORESEE study involving the CNSide platform used for diagnosing and managing leptomeningeal metastases (LM). The findings were presented at the 2024 Society for Neuro-Oncology (SNO) and American Society for Clinical Oncology (ASCO) CNS Metastases Conference in Denver.

The FORESEE trial, titled “A Therapy Treatment Response Trial in Patients with Leptomeningeal Metastases (LM) Using CNSide (FORESEE Study, NCT05414123),” was a prospective, multi-center observational study that enrolled 39 patients. These included 21 patients with breast cancer and 18 patients with non-small cell lung cancer, all with suspected or confirmed LM.

The trial's primary endpoint focused on how CNSide test results influenced clinical decision-making. The secondary endpoints compared CNSide to the gold standard CSF cytology and assessed its utility in personalizing treatment based on the tumor's molecular phenotype. The study was led by Dr. Priya U. Kumthekar, an Associate Professor of Neurology and Medicine at Northwestern University.

Key findings from the trial included:
- CNSide significantly influenced treatment decisions in over 90% of LM cases, surpassing the primary endpoint target of 20%.
- CNSide demonstrated an 80% sensitivity in detecting tumor cells compared to only 29% with traditional cytology.
- The platform identified actionable mutations in the CSF, such as HER2 amplification, which impacted 24% of therapeutic decisions.
- CNSide exhibited high specificity, with no tumor cells detected in patients without LM.

Dr. Priya U. Kumthekar emphasized that the trial met its primary and secondary endpoints, showcasing CNSide's high clinical utility. She noted that CNSide is a more sensitive and definitive test for LM, which could lead to earlier diagnoses and better patient management, potentially improving therapeutic outcomes.

About CNSide Test

CNSide is a laboratory-developed test (LDT) that uses a proprietary quantitative tumor cell capture and detection method. It includes assays to identify actionable molecular treatment targets, which can be critical as genetic changes occur when cancer metastasizes to the CNS. Evaluating cerebrospinal fluid with CNSide offers a unique opportunity to identify biomarkers and guide therapy selection. The test's quantitative tumor cell count assay can be used serially to monitor therapy response more effectively than current methods. CNSide is also being utilized in the ReSPECT-LM trial for quantifying circulating tumor cells (CTCs) as an exploratory endpoint.

About Leptomeningeal Metastases (LM)

LM is a rare but severe complication where primary cancer spreads to the cerebrospinal fluid and leptomeninges around the brain and spinal cord. It can occur from solid tumors, primary brain tumors, or hematological malignancies. Breast cancer is the most common cancer associated with LM, followed by lung cancer, gastrointestinal cancers, and melanoma. Approximately 5% of cancer patients develop LM, which is usually terminal, with a 1-year survival rate of 7% and a 2-year survival rate of 3%. The rise in LM incidence is attributed to longer cancer patient survival and the inefficacy of standard chemotherapies in the spinal fluid. There are currently no FDA-approved therapies specific for LM, leading many patients to succumb to the condition within weeks to months if untreated.

About Plus Therapeutics

Plus Therapeutics, Inc. is focused on developing targeted radiotherapeutics for challenging CNS cancers. The company’s pipeline includes product candidates for recurrent glioblastoma and leptomeningeal metastases. Combining image-guided local beta radiation and targeted drug delivery, Plus Therapeutics aims to enhance clinical outcomes for patients. The company has established a supply chain through strategic partnerships to develop, manufacture, and potentially commercialize its products. Plus Therapeutics operates in key cancer clinical development hubs in Austin and San Antonio, Texas.

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