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

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

BOLOGNA, Italy and HUNTINGDON VALLEY, Pa., Dec. 10, 2020 /PRNewswire/ -- Menarini Silicon Biosystems ^[1], 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® 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 ^[2] 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/^[3].

*The CELLSEARCH® 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 ^[4], 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 ^[5]

Contact:Linda Pavylinda.pavy@bcw-global.com ^[6]