Lapatinib Ditosylate Hydrate

Results published by the DETECT study group indicate the relevance of assessing biomarker expression in Circulating Tumor Cells (CTCs) with the minimally invasive liquid biopsy-based CELLSEARCH® platform to optimize treatment strategy and outcome in patients at an advanced stage of their disease. BOLOGNA, Italy and HUNTINGDON VALLEY, Pa., Jan. 9, 2024 /PRNewswire/ -- 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." About the DETECT study program DETECT is the largest study program utilizing Circulating Tumor Cell (CTC) count and HER2 phenotype assessment to personalize treatment strategies for HER2 negative MBC. The aim of this protocol was 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 improve long-term clinical 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 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 specific treatment decisions. For more information on the full intended use and limitations of the CELLSEARCH system, please refer to the Instructions for Use at . The CELLSEARCH HER2 tumor phenotyping reagent is available as a Research Use Only product in Europe and Asia Pacific. In the USA only, the CELLSEARCH CTC test with HER2 biomarker is available to clinicians, through Menarini Silicon Biosystems' CLIA registered clinical laboratory as a laboratory developed test. 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, 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. * The CELLSEARCH® Tumor Phenotyping Reagent (HER-2/neu) is available for Research Use Only. Not for Use in Diagnostic Procedures. CONTACT: Linda PAVY – lipavy@pavyconsulting.com Logo - View original content: SOURCE Menarini Silicon Biosystems

Findings published in the special "Cancer: Biology & Diagnostics" issue of ADLM's Clinical Chemistry journal WASHINGTON, Jan. 4, 2024 /PRNewswire/ -- A new study shows that lapatinib, a drug used for the treatment of metastatic HER2-positive cancer, is associated with improved overall survival in patients with initially HER2-negative metastatic breast cancer and HER2-positive circulating tumor cells (CTCs). This groundbreaking finding was published today in a special issue of the Association for Diagnostics & Laboratory Medicine's (formerly AACC's) Clinical Chemistry journal titled "Cancer: Biology & Diagnostics." View the full study here: About 10%-20% of all breast cancer tumors express elevated levels of a protein called HER2, which causes cells to divide uncontrollably. These HER2-positive tumors respond well to HER2-targeted therapy. However, the invasive tissue biopsies needed to measure HER2 expression levels in metastatic lesions — which can differ from levels in primary tumors — are not always feasible due to the location of the metastatic site, making it difficult to comprehensively determine HER2 status. Testing the HER2 status of CTCs, which only requires a blood sample, is a promising alternative to invasive biopsy for identifying patients with metastatic cancer who might benefit from HER2-targeted therapy. In order to assess the feasibility of this approach, the DETECT III trial sought to evaluate the efficacy of HER2-targeted lapatinib therapy for metastatic breast cancer based on a diagnosis of HER2-positive CTCs at the time of metastatic relapse. It is the largest randomized trial to ever address this question. Patients eligible for the trial had metastatic breast cancer not treatable by surgery or radiotherapy alone, as well as HER2-negative tumors and/or lesions and HER2-positive CTCs. Patients received either standard therapy (chemotherapy or endocrine therapy) or standard therapy with lapatinib, and rates of CTC clearance were assessed at various intervals during the trial. No significant differences were found in CTC clearance rates between the standard and lapatinib arms, regardless of CTCs' positivity levels and when clearance rates were measured. Patients in the lapatinib arm also showed a modest yet insignificant improvement in progression free survival rates compared to those in the standard arm. Yet remarkably, patients receiving lapatinib had a median survival time of 20.5 months, more than twice as long as patients who underwent standard therapy. The lapatinib-induced boost in overall survivability was observed throughout the length of DETECT III, which spanned over five years. The study authors speculate that lapatinib may target a specific but small subgroup of CTCs with high tumor-initiating capacity, which would account for low levels of overall CTC clearance alongside large improvements in overall survivability. "DETECT III is the first clinical study indicating that phenotyping of CTCs might have clinical utility for stratification of [metastatic breast] cancer patients to HER2-targeting therapies," the authors wrote. "CTC-guided therapy may be useful to optimize treatment strategies and should be further investigated in randomized clinical trials." About the Association for Diagnostics & Laboratory Medicine (ADLM) Dedicated to achieving better health through laboratory medicine, ADLM (formerly AACC) brings together more than 70,000 clinical laboratory professionals, physicians, research scientists, and business leaders from around the world focused on clinical chemistry, molecular diagnostics, mass spectrometry, translational medicine, lab management, and other areas of progressing laboratory science. Since 1948, ADLM has worked to advance the common interests of the field, providing programs that advance scientific collaboration, knowledge, expertise, and innovation. For more information, visit . Clinical Chemistry (clinchem.org) is the leading international journal of laboratory medicine, featuring nearly 400 peer-reviewed studies every year that help patients get accurate diagnoses and essential care. This vital research is advancing areas of healthcare ranging from genetic testing and drug monitoring to pediatrics and appropriate test utilization. Christine DeLong Association for Diagnostics & Laboratory Medicine Senior Manager, Communications & PR (p) 202.835.8722 [email protected] Molly Polen Association for Diagnostics & Laboratory Medicine Senior Director, Communications & PR (p) 202.420.7612 (c) 703.598.0472 [email protected] SOURCE Association for Diagnostics & Laboratory Medicine (ADLM)