LEADER Trial Will Use Results from Foundation Medicine’s Comprehensive Genomic Profiling Tests to Screen for Actionable Driver Mutations to Inform Trial Enrollment and Targeted Therapy Options for Patients

New “Trial in Progress” Abstract at 2022 American Society of Clinical Oncology (ASCO) Annual Meeting Details LEADER’s Primary Objective to Determine the Proportion of Patients Possessing Actionable Oncogenic Drivers to Enable Treatment Decisions

Foundation Medicine, Inc., a pioneer in molecular profiling for cancer, today announced its participation in a neoadjuvant screening trial in partnership with the Lung Cancer Research Foundation (LCRF) and Lung Cancer Mutation Consortium (LCMC). This screening trial, entitled “LCMC4 Evaluation of Actionable Drivers in EaRly Stage Lung Cancer” (LEADER), is the fourth study conducted through the LCMC and is a collaborative effort involving numerous academic study sites and pharmaceutical supporters. Foundation Medicine will be the sole provider of comprehensive genomic profiling (CGP) in the LEADER trial, which will utilize both of Foundation Medicine’s FDA-approved CGP tests: the tissue-based FoundationOne^®CDx and the blood-based FoundationOne^®Liquid CDx.

The LEADER trial is utilizing an umbrella trial design to screen for 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 as a first step to shrink a tumor before the main treatment, often surgery. By identifying patients with biomarker-positive tumors for enrollment to several matched therapeutic trials, the LEADER trial aims to develop essential data that can be used to support oncologists in their personalized treatment planning for cancer patients prior to such patients undergoing surgery.

“The neoadjuvant setting is a rapidly evolving space for the development of precision treatment options in lung cancer. Enabling trials in this setting will continue to help us understand the impact of targeted therapies in the curative treatment of NSCLC,” says Dr. Geoff Oxnard, Foundation Medicine’s VP, Head of Clinical Development. “At Foundation Medicine, we are committed to being an engaged collaborator in the pivotal research needed to shape the future of cancer care for patients at all stages, so that patients can get on the right therapy at the right time for their specific cancer.”

The results from both FoundationOne CDx and FoundationOne LiquidCDx will be used by LEADER trial sites to screen patients for actionable driver mutations. While circulating tumor DNA (ctDNA) shed is often lower in early disease, the goal of using both tests in the LEADER trial is to help researchers understand how blood-based CGP testing can complement tissue-based CGP testing to inform targeted treatment in resectable NSCLC.

In 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 testing for precision biomarkers. The FDA has also recently granted approval for neoadjuvant immunotherapy for resectable NSCLC, as well as the first-and-only immunotherapy-based treatment 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, like those who are enrolled in the LEADER trial, to become potential candidates for these personalized treatment approaches.

The LEADER trial is now open to enrollment and will include participation from trial sites and investigators across 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 others.

In a new “Trial in Progress” abstract being presented at the American Society of Clinical Oncology (ASCO) 2022 Annual Meeting from June 3-7, Boris Sepesi, M.D., 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, M.D., Attending Physician, Thoracic Oncology Service, Department of Medicine at Memorial Sloan Kettering Cancer Center will detail LEADER’s primary objective of determining the proportion of resectable NSCLC patients within the trial who possess actionable oncogenic drivers. Results from Foundation Medicine CGP testing will inform the LEADER trial sites on their selection of neoadjuvant therapy and enrollment onto independent therapeutic trials with genomically matched neoadjuvant treatment, standard therapies or other trials if no driver is detected. Read more on ASCO.org, and visit Foundation Medicine at Booth #13019 to learn more. Follow along on Twitter and LinkedIn for more details about Foundation Medicine’s data being presented at ASCO22.

About Foundation Medicine: Your Essential Partner in Cancer Care

Foundation Medicine is a pioneer in molecular profiling for cancer, working to shape the future of clinical care and research. We collaborate with a broad range of partners across the cancer community and strive to set the standard for quality, scientific excellence, and regulatory leadership. Our deep understanding of cancer biology helps physicians make informed treatment decisions for their patients and empowers researchers to develop new medicines. Every day, we are driven to help our partners find answers and take action, enabling more people around the world to benefit from precision cancer care. For more information, please visit us on www.FoundationMedicine.com and follow us on Twitter and LinkedIn.

About FoundationOne^®CDx

FoundationOne CDx is a next-generation sequencing based in vitro diagnostic device for detection of substitutions, insertion and deletion alterations (indels), and copy number alterations (CNAs) in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue specimens. 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 to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with solid malignant neoplasms. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. Some patients may require a biopsy. For a full 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 FoundationOne^®Liquid CDx

FoundationOne Liquid CDx is a qualitative next generation sequencing based in vitro diagnostic test for prescription use only that uses targeted high throughput hybridization-based capture technology to analyze 324 genes utilizing circulating cell-free DNA (cfDNA) isolated from plasma derived from anti-coagulated peripheral whole blood of advanced cancer patients. The test is FDA-approved 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 the Intended Use) in accordance with the approved therapeutic product labeling. Additional genomic findings may be reported and are not prescriptive or conclusive for labeled use of any specific therapeutic product. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. Patients who are negative for companion diagnostic mutations should be reflexed to tumor tissue testing and mutation status confirmed using an FDA-approved tumor tissue test, if feasible. For the complete label, including companion diagnostic indications and complete risk information, please visit www.F1LCDxLabel.com.

Foundation Medicine^® and FoundationOne^® are registered trademarks of Foundation Medicine, Inc.

Source: Foundation Medicine

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