#United States #Breast Cancer #Menarini #CTC #Huntingdon Valley

Menarini Silicon Biosystems' PACE Trial Results

Menarini Silicon Biosystems has published pivotal findings from its PACE trial, which explores the clinical advantages of enumerating circulating tumor cells (CTCs) in patients with a specific subtype of metastatic breast cancer. This research, featured in Clinical Cancer Research, is particularly focused on individuals with hormone receptor-positive (HR+) and HER2-negative (HER2-) cancer, who have shown progression after initial treatments with aromatase inhibitors and CDK4/6 inhibitors.

Background

The importance of CTC counts in aiding healthcare professionals to adjust treatment plans has gained traction in oncology. The secondary analysis conducted in the PACE trial emphasizes how counting these cells circulating in the bloodstream can assist in deciding whether to intensify or reduce treatment when managing women with metastatic breast cancer.

In total, 203 participants were randomized to receive either monotherapy or combination therapy. The combination treatments varied from dual therapy, which includes an endocrine therapy coupled with a CDK4/6 inhibitor, to a triple approach involving both along with an immune checkpoint inhibitor.

Trial Findings

Patients in the study were categorized into two prognostic groups based on their CTC levels: those with fewer than 5 CTCs per 7.5 ml of blood, classified as having indolent disease, and those with 5 or more CTCs, deemed to have aggressive disease. While overall survival rates did not significantly differ between the treatment groups in the entire study population, notable benefits emerged for patients classified with aggressive disease. Those receiving combined therapies exhibited a 57% reduction in the risk of disease progression compared to monotherapy, while those on triple therapy experienced a remarkable 74% risk reduction.

Expert Insights

Dr. Lorenzo Gerratana, a physician-researcher at IRCCS CRO Aviano in Italy and lead author of the biomarker analysis, remarked, "This analysis spotlights the utility of CTC enumeration for identifying patients most likely to benefit from intensified treatments following progression on initial therapy. Aggressive disease forms achieved substantially better clinical outcomes with combination treatment, whereas indolent forms did not show significant treatment advantages over monotherapy."

Despite the advancements, the biological mechanisms behind resistance to CDK4/6 inhibitors remain inadequately understood, fostering a significant demand for reliable biomarkers that can guide therapeutic decisions after disease progression.

Correlation with Prior Research

These findings resonate with earlier results from the STIC trial, which indicated how therapeutic decisions informed by CTC counts could differ from clinicians’ choices and lead to improved survival rates or allow for the reduction of treatment without negatively impacting survival outcomes.

Conclusion

Fabio Piazzalunga, President of Menarini Silicon Biosystems, emphasized the consistency in findings across the STIC and PACE trials, asserting that their CELLSEARCH CTC enumeration system is pivotal in improving care strategies within the complex landscape of metastatic breast cancer. The CELLSEARCH test is currently available for clinical use in Europe and China and through a CAP/CLIA/ISO 15189 accredited laboratory located in Huntingdon Valley, Pennsylvania, USA.

About CELLSEARCH

CELLSEARCH is renowned for being the first clinically validated blood test designed to detect and enumerate CTCs, contributing significantly to the management of patients with metastatic cancers, including breast, prostate, and colorectal cancers. It is essential to note that while CELLSEARCH is a valuable tool for clinical practice, it is not approved to directly guide specific therapeutic decisions. Clinical data discussed here pertain to experimental uses of the system beyond its approved indications.

Corporate Overview

Menarini Silicon Biosystems, headquartered in Bologna, Italy, and Huntingdon Valley, Pennsylvania, is a wholly-owned subsidiary of the Menarini Group, a global pharmaceutical and biotechnology firm based in Florence, Italy, employing over 17,000 professionals across 140 countries.