CAMBRIDGE, Mass.–(BUSINESS WIRE)–Foundation Medicine, Inc., a pioneer in cancer molecular profiling, today announced its participation in a neoadjuvant screening trial in partnership with the Lung Cancer Research Foundation (LCRF) and the Lung Cancer Mutation Consortium (LCMC). This screening test, titled “LCMC4 Eevaluation of Aexploitable Drivers in EaRAdvanced stage lung cancer(LEADER), is the fourth study conducted by the LCMC and is a collaborative effort involving numerous academic study sites and pharmaceutical supporters. Foundation Medicine will be the sole provider of full genomic profiling (CGP) in the LEADER trial, which will use Foundation Medicine’s two FDA-cleared CGP tests: the tissue-based FoundationOne®CDx and the blood-based FoundationOne®Liquid CDx.
The LEADER trial uses an umbrella assay design to screen 11 actionable driver mutations in 1,000 patients with high-risk resectable non-small cell lung cancer (NSCLC). These patients are candidates for neoadjuvant therapy, which is treatment given first to shrink a tumor before the main, often surgical, treatment. By identifying patients with biomarker-positive tumors to enroll them in multiple matched therapeutic trials, the LEADER trial aims to develop critical data that can be used to support oncologists in their personalized treatment planning for cancer patients before that these patients do not undergo surgery.
“The neoadjuvant setting is a rapidly evolving space for the development of precision treatment options in lung cancer. Enabling trials in this context will continue to help us understand the impact of targeted therapies in the curative treatment of NSCLC,” says Dr. Geoff Oxnard, Vice President of Foundation Medicine, Head of Clinical Development. “At Foundation Medicine, we are committed to being an engaged collaborator in the essential research needed to shape the future of cancer care for patients at all stages, so that patients can receive the right treatment at the right time for their specific cancer.”
Results from FoundationOne CDx and FoundationOne LiquidCDx will be used by LEADER trial sites to screen patients for workable driver mutations. Although loss of circulating tumor DNA (ctDNA) is often lower early in disease, the goal of using both tests in the LEADER trial is to help researchers understand how blood CGP tests can complement tissue PGC testing to inform targeted therapy in resectable NSCLC.
Over the past two years, the FDA has granted approvals for the first tyrosine kinase inhibitor and checkpoint inhibitor, respectively, for the adjuvant treatment of resected NSCLC, each requiring precision biomarker testing. The FDA has also recently granted approval for neoadjuvant immunotherapy of resectable NSCLC, as well as first and only treatment based on immunotherapy for neoadjuvant use in NSCLC, reinforcing the value of targeted therapies as a component of curative lung cancer. These FDA approvals could better position early-stage NSCLC patients, such as those enrolled in the LEADER trial, to become potential candidates for these personalized treatment approaches.
The LEADER trial is now open for enrollment and will include participation from trial sites and investigators from the oncology community, including MD Anderson Cancer Center, Memorial Sloan Kettering Cancer Center, Dana Farber Cancer Institute, Yale Cancer Center/Smilow Cancer Hospital and many more.
In a new “Trial in Progress” abstract presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting June 3-7, Boris Sepesi, MD, associate professor of thoracic and cardiovascular surgery at the University of Texas MD Anderson Cancer Center, and Principal Investigator of the LEADER trial, and Mark Kris, MD, Attending Physician, Department of Thoracic Oncology, Department of Medicine at Memorial Sloan Kettering Cancer Center, will detail LEADER’s primary goal of determining the proportion of patients with resectable NSCLC within the trial who possess actionable oncogenic factors. Foundation Medicine CGP test results will inform LEADER trial sites on their neoadjuvant therapy selection and enrollment in independent therapeutic trials with genomically compatible neoadjuvant therapy, standard therapies, or other trials if no factors are detected . Learn more about ASCO.org, and visit Foundation Medicine at booth #13019 to learn more. follow on Twitter and LinkedIn for more details on the Foundation Medicine data presented at ASCO22.
About Foundation Medicine: Your Essential Partner in Cancer Care
Foundation Medicine is a pioneer in molecular cancer profiling, working to shape the future of clinical care and research. We collaborate with a wide range of partners in the cancer community and strive to set the standard for quality, scientific excellence and regulatory leadership. Our deep understanding of cancer biology helps doctors make informed treatment decisions for their patients and enables researchers to develop new drugs. Every day, we are committed to helping our partners find answers and take action, enabling more people around the world to benefit from precision cancer care. For more information, visit us at www.FoundationMedicine.com and follow us on Twitter and LinkedIn.
About Foundation One®CDx
FoundationOne CDx is next-generation sequencing based on in vitro diagnostic device for the detection of substitutions, insertion and deletion alterations (indels) and copy number alterations (CNA) in 324 genes and rearrangements of selected genes, as well as genomic signatures, including the microsatellite instability (MSI) and tumor mutation load (TMB) using DNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue samples. FoundationOne CDx is for prescription use only and is intended as a companion diagnostic to identify patients who may benefit from treatment with certain targeted therapies in accordance with their approved therapeutic product labeling. Additionally, FoundationOne CDx is intended to provide tumor mutation profiling for use by qualified healthcare professionals in accordance with professional oncology guidelines for patients with solid malignant neoplasms. Use of the test does not guarantee that a patient will be matched to a treatment. A negative result does not exclude the presence of an alteration. Some patients may require a biopsy. For a complete list of targeted therapies for which FoundationOne CDx is indicated as a companion diagnostic, please visit http://www.foundationmedicine.com/genomic-testing/foundation-one-cdx.
About Foundation One®Liquid CDx
FoundationOne Liquid CDx is a next-generation sequencing-based qualitative in vitro diagnostic test for prescription use only that uses high-throughput hybridization-based targeted capture technology to analyze 324 genes using cell-free DNA (cfDNA) isolated from plasma derived from peripherally anticoagulated whole blood of patients with advanced cancer. The test is FDA-cleared to report short variants in over 300 genes and is a companion diagnostic to identify patients who may benefit from treatment with specific therapies (listed in Table 1 of Intended Use) in accordance to the labeling of the approved therapeutic product. Additional genomic findings may be reported and are not prescriptive or conclusive for the labeled use of a specific therapeutic product. Use of the test does not guarantee that a patient will be matched to a treatment. A negative result does not exclude the presence of an alteration. Patients who are negative for associated diagnostic mutations should be referred for tumor tissue testing and mutation status confirmed using an FDA-cleared tumor tissue test, if possible. For the full label, including associated diagnostic indications and full risk information, please visit www.F1LCDxLabel.com.
Basic medicine® and Foundation One® are registered trademarks of Foundation Medicine, Inc.
Source: Foundation Medicine