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DETECT program studies validate clinical relevance of CTC HER2 phenotypes in metastatic breast cancer patients with HER2 negative primary tumor and positive impact of reference anti-HER2 treatment on overall survival

BOLOGNA, Italy and HUNTINGDON VALLEY, Pa., Dec. 10, 2020 /PRNewswire-AsiaNet/ --

- Results presented at the 2020 San Antonio Breast Cancer Symposium confirm the

relevance of screening for HER2+ CTCs from blood samples in patients with a

HER2 negative primary tumor biopsy to optimize treatment strategy and patient

outcome

Menarini Silicon Biosystems

[https://c212.net/c/link/?t=0&l=en&o=2974193-1&h=2883067015&u=http%3A%2F%2Fwww.siliconbiosystems.com%2F&a=Menarini+Silicon+Biosystems ], a pioneer of liquid

biopsy technology, announced today new data from the DETECT study program.

These data focused on women with HER2 negative metastatic breast cancer (MBC)

based on primary tumor biopsy, and HER2+ CTCs. The results of this large

program demonstrate that screening for HER2+ CTCs, in the blood samples of

these patients, is an important tool to guide therapy decisions and improve

patient outcomes. Furthermore, the randomized DETECT III phase III study,

discussed in a poster spotlight session during the 2020 San Antonio Breast

Cancer Symposium, shows that adding reference HER2 targeted TKI (tyrosine

kinase inhibitor) lapatinib to standard therapy has a positive impact on OS

(overall survival) in this particular patient population. DETECT program is the

largest screening analysis to-date on the added value of taking into

consideration HER2+ overexpression by CTCs in women with a primary HER2

negative breast cancer tumor biopsy, to optimize patient management.

Prof. Dr. med. Tanja N. Fehm, full Professor and Head of the Department of

Gynecology & Obstetrics at the Heinrich-Heine University of Düsseldorf,

Germany, said: "The results obtained in the overall DETECT program clearly

indicate that CTC HER2 status is an additional important prognostic and

predictive tool to CTC enumeration, because it allows us to better understand,

beyond the information gathered from the primary tumor biopsy, what our most

critical patients need, so that we can provide them with better care."

Metastatic disease remains, indeed, the principal cause of cancer related

deaths. CTCs have repeatedly been shown to represent qualified biomarkers to

decipher various clinical and molecular complexities of advanced cancers. "The

opportunity provided by the DETECT III study, to optimize treatment for

patients with metastatic disease who are initially diagnosed with HER2

negative- breast cancer and therefore logically deprived of the HER2 therapy

they may actually need, is likely to remove a significant roadblock in the

search for a cure to the high burden of this distant recurrent type of breast

cancer," she added.

More than 1,900 patients with HER2 negative MBC were screened for CTC

enumeration and phenotype using Menarini Silicon Biosystems' CELLSEARCH(R) CTC

System. The CTCs were labeled with an anti HER2 antibody*, stained and

classified according to staining intensity. HER2 status of CTCs was assessed in

1,159 CTC-positive patients. A total of 174 (15.0%) patients had a CTC count

≥1 with strong HER2 staining. This situation was significantly

associated, in a univariate analysis, with shorter OS.

Finally 105 patients with moderate-to-strong positive CTC-HER2 staining were

enrolled in the DETECT III study and randomized to either the lapatinib in

combination with standard therapy arm or standard therapy alone arm. Patients

in the lapatinib arm had a significantly improved OS. In addition, patients

with no evidence of CTC (CTC0), at the time of first follow-up within a median

of 73 days, showed better OS compared to patients with CTCs (HR 0.36; 95% CI

0.17 – 0.76; p-value= 0.005). The main conclusion of the DETECT program is that

HER2 over expression on CTCs, in patients with metastatic HER2 negative primary

breast cancer, provides a key signal to physicians to consider a more

appropriate therapeutic option.

"Breast cancer is a heterogenous disease with an increasing number of

therapeutic strategies that physicians can prescribe depending on individual

patient characteristics and for which they are eager to obtain appropriate

noninvasive diagnostic tools to help them optimize their choices in real-time,"

said Cecilia Simonelli, MD and Global Medical Affairs Head at Menarini Silicon

Biosystems. "We are particularly committed to leveraging our technology so that

this becomes possible and so that we can contribute to the ultimate goal of

allowing even the most difficult cancers to become curable."

About the DETECT study program

DETECT is the largest study program on the role of Circulating Tumor Cell (CTC)

count and HER2 phenotype assessment to personalize treatment strategies for

HER2 negative MBC. The aim of this program is 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 optimize patient

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

[https://c212.net/c/link/?t=0&l=en&o=2974193-1&h=3104001831&u=http%3A%2F%2Fwww.cellsearchctc.com%2F&a=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 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/

[https://c212.net/c/link/?t=0&l=en&o=2974193-1&h=1885058484&u=http%3A%2F%2Fdocuments.cellsearchctc.com%2F&a=http%3A%2F%2Fdocuments.cellsearchctc.com%2F

].

*The CELLSEARCH(R) Tumor Phenotyping Reagent (HER-2/neu) is for Research Use

Only. Not for Use in Diagnostic Procedures. The performance characteristics and

safety have not been established and are not cleared or approved by the FDA.

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

[https://c212.net/c/link/?t=0&l=en&o=2974193-1&h=2883067015&u=http%3A%2F%2Fwww.siliconbiosystems.com%2F&a=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.

http://www.siliconbiosystems.com/press-releases/new-research-study-supports-clinical-utility-of-circulating-tumor-cell-count-for-metastatic-breast-cancer

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Contact:

Linda Pavy

linda.pavy@bcw-global.com

Source: Menarini Silicon Biosystems