Results published by the DETECT study group indicate the relevance of assessing biomarker expression in Circulating Tumor Cells (CTCs) with the minimally invasive liquid biopsy-based CELLSEARCH® platform to optimize treatment strategy and outcome in patients at an advanced stage of their disease.

BOLOGNA, Italy and HUNTINGDON VALLEY, Pa., January 9, 2024 –Menarini Silicon Biosystems, a pioneer of liquid biopsy technology, announced today the publication in the Journal of Clinical Chemistry of the final results of the multicenter DETECT III clinical trial. This interventional, investigator-initiated, phase III trial evaluated the efficacy of HER2-targeted therapy in metastatic breast cancer patients with HER2 negative tissue biopsy of the primary and/or metastatic site and HER2 positive CTCs detected with the CELLSEARCH system. Patients randomized to the treatment arm with reference HER2-targeted TKI (Tyrosine Kinase Inhibitor) lapatinib, in addition to standard therapy, showed greater overall survival (OS) over patients treated with standard therapy alone. This allowed physicians to consider early initiation of HER2-targeted therapy. Based on the primary tumor and/or metastatic site characteristics and the current standard of care those patients would not have been eligible for HER2 targeted therapy.

According to Prof. Dr. med. Wolfgang Janni, MD, PhD, Professor and Chair of the Department of Obstetrics and Gynecology at the University of Ulm, Germany, study director of the DETECT III trial: “the results of this trial suggest the potential of CTCs as noninvasive surrogates for invasive tissue-based biomarkers, as well as an early monitoring tool. CTC phenotyping could contribute to personalized treatment approaches that allow us to improve management of patients with advanced disease and discordant expression of the HER2 receptor”.

A total of 2,137 patients with HER2 negative MBC were screened for HER2 positive CTCs using Menarini Silicon Biosystems' CELLSEARCH® CTC System and the CELLSEARCH HER2 tumor phenotyping reagent*. 105 patients, with at least one detected HER2 positive CTC in the initial CTC screening phase, were randomized to either lapatinib in combination with standard therapy or to standard therapy alone. Patients in the lapatinib arm had a significantly improved OS with a median survival time of 20.5 months compared to a median survival time of 9.1 months for patients in the standard arm (HR 0.54; 95% CI 0.34–0.86; p = 0.008). While investigators acknowledge some limitations in the study design, the results indicate that CTC-guided treatment allocation may help optimize treatment strategies and should therefore be further investigated. The study also confirmed the prognostic role of CELLSEARCH CTC enumeration. Patients with no evidence of CTCs at the time of first follow-up showed a 3-fold increase in OS compared to patients with CTCs (42.4 months vs 14.1 months median OS; HR 0.33; 95% CI 0.16–0.68; p = 0.002)

“We are thrilled by the fact that the DETECT III study provides additional data further elucidating the potential value of our minimally invasive CELLSEARCH technology,” said Fabio Piazzalunga, President of Menarini Silicon Biosystems. "This study is another example of why we are so committed to pursuing our investments in the CELLSEARCH platform in different cancer settings.”

About the DETECT study program

DETECT is the largest study program utilizing Circulating Tumor Cell (CTC) count and HER2 phenotype assessment to personalize treatment strategies for HER2 negative MBC. The aim of this protocol was to evaluate the impact of adapting therapeutic interventions based on CTC phenotypes in patients with a discordant HER2 negative primary tumor biopsy and HER2+ over expression of CTCs in the metastatic setting. The study results consistently show the importance of adding HER2 targeted therapy in this patient population to improve long-term clinical outcomes.

About CELLSEARCH

CELLSEARCH is the first and only clinically validated blood test cleared by the U.S. Food & Drug Administration (FDA) for detecting and counting CTCs to aid physicians in managing patients with metastatic breast, prostate, and colorectal cancers when used in conjunction with other clinical methods of monitoring. The test is also approved by the China National Medical Products Administration (NMPA) for use in monitoring patients with Metastatic Breast Cancer. The CELLSEARCH System is the most extensively studied CTC technology, with research published in more than 650 peer-reviewed publications.

CELLSEARCH Circulating Tumor Cell Kit is not cleared or approved for use to guide specific treatment decisions. For more information on the full intended use and limitations of the CELLSEARCH system, please refer to the Instructions for Use at http://documents.cellsearchctc.com/.

 

The CELLSEARCH HER2 tumor phenotyping reagent is available as a Research Use Only product in Europe and Asia Pacific.

In the USA only, the CELLSEARCH CTC test with HER2 biomarker is available to clinicians, through Menarini Silicon Biosystems’ CLIA registered clinical laboratory as a laboratory developed test.

About Menarini Silicon Biosystems

Menarini Silicon Biosystems offers unique rare cell technologies and solutions that provide clinical researchers with access to unparalleled resolution in the study of cells and their molecular characterization.

Menarini Silicon Biosystems, based in Bologna, Italy, and Huntingdon Valley, Pa., U.S., is a wholly owned subsidiary of the Menarini Group, a multinational pharmaceutical, biotechnology and diagnostics company headquartered in Florence, Italy, with more than 17,000 employees in 140 countries.

* The CELLSEARCH® Tumor Phenotyping Reagent (HER-2/neu) is available for Research Use Only. Not for Use in Diagnostic Procedures.

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