Country for PR: United Kingdom
Contributor: PR Newswire Europe
Friday, December 11 2020 - 01:12
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 

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 D¨¹sseldorf, 
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 
¡Ý1 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 ¨C 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 


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 treatment decisions. For more information on the full intended use and 
limitations of the CELLSEARCH system, please refer to the Instructions for Use 

*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], 
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.

Logo -

Linda Pavy

Source: Menarini Silicon Biosystems