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."