U.S. Food and Drug Administration Approves FoundationOne®Liquid CDx as a Companion Diagnostic for TEPMETKO® (tepotinib) to Identify Patients with MET Exon 14 Skipping Alterations in Non-Small Cell Lung Cancer

FoundationOne Liquid CDx is the first FDA-approved companion diagnostic to identify patients who may be eligible for TEPMETKO^®

Foundation Medicine, Inc. today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOne^®Liquid CDx to be used as a companion diagnostic for TEPMETKO^® (tepotinib) developed by EMD Serono, the healthcare business of Merck KGaA, Darmstadt, Germany in the U.S. and Canada. TEPMETKO received accelerated approval from the FDA in February 2021 and traditional approval in February 2024 for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations (METex14).¹ FoundationOne Liquid CDx is the first FDA-approved companion diagnostic to identify patients who may be eligible for TEPMETKO.

NSCLC accounts for approximately 85% of lung cancers,² of which 3-4% are associated with METex14.³ METex14 skipping alterations in patients have been associated with advanced disease and a poor prognosis.⁴

“Access to a high-quality liquid biopsy, like FoundationOne Liquid CDx, can help unlock the power of precision medicine for more patients with non-small cell lung cancer,” said Mia Levy, M.D., Ph.D., chief medical officer at Foundation Medicine. “We’re proud that our liquid biopsy is the first companion diagnostic approved in the U.S. for TEPMETKO as it will help identify more patients with METex14 skipping alterations who may be appropriate for targeted treatment.”

Foundation Medicine is the only company with an FDA-approved portfolio of tissue and blood-based comprehensive genomic profiling tests. From a routine blood sample, FoundationOne Liquid CDx analyzes more than 300 cancer-related genes to provide genomic insights.

With today’s approval, Foundation Medicine has more than 19 FDA-approved companion diagnostic indications for NSCLC, the most of any company.⁵

“Targeted therapies have led a revolution to how lung cancer is treated,” said GO2 for Lung Cancer President and CEO Laurie Ambrose. “Biomarker testing plays a crucial part in getting these treatments into the hands of patients. We’re excited to see that patients with advanced NSCLC have more access to treatment options because of non-invasive liquid biopsies.”

Foundation Medicine is the global leader in approved companion diagnostic indications, with 50% of all approved companion diagnostic indications for next-generation sequencing (NGS) testing in the United States and Japan.⁶

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

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 LinkedIn and X.

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 genomic alteration 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.

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1</sup> TEPMETKO. Prescribing Information. EMD Serono; 2024. Accessed May 24, 2024. https://www.emdserono.com/us-en/pi/tepmetko-pi.pdf

² American Cancer Society. Key Statistics for Lung Cancer. Updated January 29, 2024. Accessed May 22, 2024. https://www.cancer.org/cancer/types/lung-cancer/about/what-is.html

³ The Cancer Genome Atlas Research Network. Comprehensive molecular profiling of lung adenocarcinoma. Nature. 2014;511:543-550. https://doi.org/10.1038/nature13385

⁴ Awad MM, Leonardi GC, Kravets S, et al. Impact of MET inhibitors on survival among patients with non-small cell lung cancer harboring MET exon 14 mutations: a retrospective analysis. Lung Cancer. 2019;133:96-102. https://doi.org/10.1016/j.lungcan.2019.05.011

⁵ Data on File, Foundation Medicine, Inc. 2024

⁶ Data on File, Foundation Medicine, Inc. 2024

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