New Research Study Supports Clinical Utility of Circulating Tumor Cell Count for Metastatic Breast Cancer

First randomized clinical trial demonstrating that CTC count may help personalize treatment choices

BOLOGNA,Italy and HUNTINGDON VALLEY,Pa.,Nov. 9,2020 --Menarini Silicon Biosystems,the pioneer of liquid biopsy technology,today announced the publication of a research study providing support for the reliability of using circulating tumor cell (CTC) count to guide frontline therapy choice for patients with estrogen receptor-positive (ER+),HER2-negative (HER2) metastatic breast cancer. Published in the November issue of JAMA Oncology,this is the first study to support clinical utility of CTC count in a randomized clinical trial.

"Based on our research,the use of the CTC count represents the first objective and reproducible decision tool to help physicians choose between hormone therapy or chemotherapy for this particular group of patients," said lead author Francois-Clement Bidard,MD,PhD,Professor of Medical Oncology at Institut Curie and University of Versailles. "Furthermore,our results indicate thattheCTC count complements but does not duplicate the physician's opinion on which treatment to choose and should be included in the decision algorithm. This CTC test may help customizing treatment decisions for all women suffering from ER+ HER2- metastatic breast cancer".

The randomized Phase III trial,known as the STIC CTC study,included 778 women with Stage 4 ER+,HER2- breast cancer and compared the outcomes of treatment decisions based on physician assessment vs. CTC count. Half of the patients were randomly assigned to the clinically driven treatment group,where treatment was selected by a physician based on clinical factors. The other half were assigned to a CTC-driven treatment group,in which patients with 5 or more CTCs in 7.5 mL of blood received chemotherapy,and those with less than 5 CTCs in 7.5 mL received hormone therapy. Menarini Silicon Biosystems' CELLSEARCH® CTC System was used to capture and isolate tumor cells circulating in the blood in all patients.

The results supported the reliability and clinical utility of using the CTC count to guide front line therapy choice. For most patients in the clinically driven arm,the CTC count correlated with the physician's choice of treatment. In the CTC-driven group,escalation of treatment to frontline chemotherapy for patients with high CTC count significantly improved progression free survival (PFS),while de-escalation to hormone therapy for patients with low CTC count did not have a detrimental impact on PFS or overall survival (OS).

"The results of the STIC CTC study provide evidence that the CTC count can support physicians when making effective treatment decisions," said Fabio Piazzalunga,President and CEO of Menarini Silicon Biosystems. "As a company,we will continue to supportresearch aimed at demonstrating the clinical utility of CTC and we maintain our commitment to improve patient management".

Since the trial began,the introduction of CDK4/6 inhibitors (palbociclib,ribociclib and abemaciclib) in combination with endocrine therapyas a frontline optionhas changed the treatment algorithm for patients with ER+ HER2- metastatic breast cancer. As a result,Menarini Silicon Biosystems has now been asked to support the analysis of CTC count in an ongoing phase III studyknown asAMBRE,promoted by Unicancer,the only French hospital network entirely devoted to fighting cancer,and conducted within the French breast cancer intergroup (UCBG) network. The study (NCT04158362) compares chemotherapy and a combination of endocrine therapy with one of the new CDK4/6 inhibitors (abemaciclib) as the initial treatment for metastatic ER+/HER2- breast cancer with high tumor burdend.

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 Systemis 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 as a clinical utility test for guiding treatment decisions. For more information on the full intended use and limitations of CELLSEARCH system,please refer to the Instructions for Use at http://documents.cellsearchctc.com/.

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,U.S.,is a wholly owned subsidiary of the Menarini Group,a multinational pharmaceutical,biotechnology and diagnostics company headquartered in Florence,with more than 17,000 employees in 140 countries.

Contact: Liz Dowling,(415) 388-2794

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Liz@dowlingdennis.net