#Italy #Bologna #Menarini #CELLSEARCH® #PACE Study

Menarini Silicon Biosystems Unveils PACE Study Findings

Menarini Silicon Biosystems, a pioneer in cell-based liquid biopsy technology, recently announced promising results from the PACE study, focusing on the utility of CELLSEARCH® circulating tumor cell (CTC) enumeration in treating hormone receptor-positive (HR+), HER2-negative, metastatic breast cancer. These findings, published in Clinical Cancer Research, showcase the significance of CTC count as a guideline for therapy escalation after disease progression.

The second analysis of the PACE trial underscores the importance of monitoring CTCs in the blood as a predictive biomarker. This analysis was aimed at determining whether CTC counts could provide prognostic information for patients with HR+/HER2- metastatic breast cancer who had progressed after first-line treatment with aromatase inhibitors plus CDK4/6 inhibitors.

Involving 203 patients, the study randomized participants into two groups: one group received endocrine monotherapy, while the other underwent combination therapy involving either double treatment (endocrine therapy plus a CDK4/6 inhibitor) or triple therapy (endocrine therapy, CDK4/6 inhibitor, and an immune checkpoint inhibitor). The dividing point was set at a CTC level of 5 or more per 7.5 ml of blood, categorizing patients into 'indolent' (less than 5 CTCs) and 'aggressive' disease classifications.

Interestingly, while no substantial difference in progression-free survival was found across treatment groups for the overall population, patients categorized with aggressive disease showed noteworthy results. Those treated with combination therapies experienced a significant reduction in progression risk: a 57% decrease for the double therapy group and a 74% decrease for the triple therapy group compared to those receiving monotherapy.

Dr. Lorenzo Gerratana, an associate professor at the University of Udine and lead author on the PACE biomarker analysis, emphasized the findings, stating that CTC counts can better identify HR+/HER2- metastatic breast cancer patients who may benefit from more aggressive treatment post-progression. This distinction is crucial, as patients with aggressive disease benefited from combination therapies, while indolent patients showed no substantial advantage from intensified treatment.

With the mechanisms behind resistance to CDK4/6 inhibitors yet to be fully understood, reliable biomarkers like CTC counts are essential for guiding treatment following disease progression. These insights resonate with findings from the STIC study, which showed that treatment decisions based on CTC values could diverge from standard physician evaluations, potentially leading to enhanced survival outcomes or enabling treatment de-escalation without compromising patient wellbeing.

Fabio Piazzalunga, President of Menarini Silicon Biosystems, remarked, 'The STIC and PACE studies consistently illustrate how our CELLSEARCH CTC enumeration can enhance patient management in heterogeneous metastatic breast cancer scenarios, where both resistance mechanisms and disease progression present ongoing challenges. This testing is available for in vitro diagnostics in Europe and China, and through our accredited lab in Huntingdon Valley, PA, for the U.S. market.'

About CELLSEARCH

CELLSEARCH is the only CE-marked clinically validated blood test approved by the U.S. Food and Drug Administration (FDA) for the detection of CTCs, assisting physicians in treating patients with metastatic breast, prostate, and colorectal cancer. However, it's important to note that the CELLSEARCH kit for circulating tumor cells is not approved for guiding specific treatment decisions.

About Menarini Silicon Biosystems

Based in Bologna, Italy, and Huntingdon Valley, PA, USA, Menarini Silicon Biosystems is a wholly-owned subsidiary of the Menarini Group, a multinational pharmaceutical, biotechnology, and diagnostics company headquartered in Florence, Italy, with over 17,000 employees in 140 countries.