#USA #Metastatic Breast Cancer #Huntingdon Valley #CELLSEARCH #Menarini Silicon Biosystems

Menarini Silicon Biosystems Unveils PACE Trial Results

Menarini Silicon Biosystems has recently announced pivotal findings from the PACE trial, which highlight the potential of Circulating Tumor Cells (CTCs) as biomarkers to inform treatment strategies for patients with hormone receptor-positive (HR+), HER2-negative (HER2-) metastatic breast cancer. This study aims to guide treatment decisions for individuals who have shown progression after initial therapies involving aromatase inhibitors along with CDK4/6 inhibitors.

The Significance of CTC Enumeration

The secondary analysis of the PACE trial, published in Clinical Cancer Research, evaluated whether counting CTCs in a blood sample could provide prognostic insights for patients experiencing disease progression. Conducted across multiple centers since 2017, this clinical trial involved 203 participants who were assigned to either a monotherapy regimen or a combination treatment approach—either a doublet (endocrine therapy and a CDK4/6 inhibitor) or a triplet therapy that integrated an immune checkpoint inhibitor.

Patients were categorized based on their CTC counts: those with fewer than 5 CTCs per 7.5 mL of blood were identified as having indolent disease, while those with 5 or more CTCs were deemed to have aggressive disease. Interestingly, while an overall difference in progression-free survival was not evident across the treatment cohorts, patients exhibiting aggressive disease experienced significant enhancements in treatment outcomes with combination therapies. Specifically:

• - Patients undergoing doublet therapy saw a 57% reduction in the risk of disease progression.
• - For those receiving triplet therapy, the risk diminished by an impressive 74% compared to monotherapy.

Expert Insights

Dr. Lorenzo Gerratana, an Associate Professor at the University of Udine and one of the lead authors of the analysis, emphasized the utility of CTC enumeration in identifying patients who would gain the most from intensified treatment after showing disease progression. His insights underline that while aggressive disease patients reap substantial rewards from combination therapies, those classified with indolent disease do not experience significant benefits from escalating treatment regimens.

The biological mechanisms behind resistance to CDK4/6 inhibitors remain poorly understood, which underscores the pressing need for reliable biomarkers to steer treatment choices following disease advancement.

Consistency in Research Findings

The results align with previous conclusions from the STIC trial published in 2024. This earlier research indicated that treatment choices driven by CTC enumeration might diverge from medical decisions made by healthcare professionals and could lead to better survival outcomes or allow for treatment reductions without a detrimental impact on overall survival.

Enhancing Patient Management

Fabio Piazzalunga, President of Menarini Silicon Biosystems, remarked on the coherence of findings from both the STIC and PACE trials. He noted that their CELLSEARCH CTC enumeration technology significantly improves management strategies for patients facing the diverse challenges presented by metastatic breast cancer, especially in understanding resistance mechanisms and managing disease progression.

Currently, the CELLSEARCH test is available for in vitro diagnostic utilization in Europe and China, and within the United States, it is accessible through a certified lab in Huntingdon Valley, Pennsylvania. The company remains committed to providing healthcare professionals with tools to make better-informed treatment decisions, whether that means intensifying therapy to combat disease progression or moderating treatment intensity to maintain quality of life for patients.

About CELLSEARCH

CELLSEARCH stands out as the sole CE-marked and FDA-cleared blood test designed to enumerate CTCs. This test assists doctors in managing patients with metastatic forms of breast, prostate, and colorectal cancers. However, it is essential to note that the CELLSEARCH CTC Kit is not sanctioned for making specific treatment decisions; the clinical data referenced regarding CTC enumeration utilizes the technology in ways not explicitly cleared by regulatory bodies.

For further detail on the intended use and constraints of the CELLSEARCH system, please refer to the corresponding Instructions for Use.

About Menarini Silicon Biosystems

Menarini Silicon Biosystems operates out of Bologna, Italy, and Huntingdon Valley, Pennsylvania, as a wholly-owned entity under the Menarini Group—a sizeable multinational firm specializing in pharmaceuticals, biotechnology, and diagnostics. Based in Florence, Italy, the company employs over 17,000 personnel across 140 nations.