On September 18, 2020 Foundation Medicine, Inc. and Takeda Pharmaceuticals USA, Inc., a wholly-owned subsidiary of Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK), reported a collaboration for the development of Foundation Medicine’s tissue- and blood-based companion diagnostics for use with marketed and investigational treatments in Takeda’s late-stage lung cancer portfolio (Press release, Foundation Medicine, SEP 18, 2020, View Source [SID1234565350]). If approved, the appropriate companion diagnostics would be used to identify patients who may be eligible for mobocertinib, an investigational drug being evaluated for the treatment of patients with epidermal growth factor receptor (EGFR) Exon20 insertion+ metastatic non-small cell lung cancer (mNSCLC), and ALUNBRIG (brigatinib), Takeda’s tyrosine kinase inhibitor (TKI) recently FDA-approved to treat patients with TKI-naïve anaplastic lymphoma kinase-positive (ALK+) mNSCLC.
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NSCLC is the most common form of lung cancer, accounting for approximately 85 percent of the estimated 1.8 million new patients diagnosed each year worldwide;1 ,2 and forty percent of patients with NSCLC are diagnosed with metastatic disease.3 EGFR Exon20 insertion mutations occur in approximately 1-2 percent of patients with mNSCLC and these patients have no FDA-approved treatment options designed to target these Exon20 alterations.4, 5 ALK+ mNSCLC is a complex and aggressive form of lung cancer found in approximately 3-5 percent of patients with mNSCLC.6,7,8
"Our collaboration with Foundation Medicine will address an urgent need for broad access to genomic tests, ultimately expanding treatment options and potentially improving outcomes for people with ALK+ and EGFR Exon20 insertion+ mNSCLC," said Christopher Arendt, Head, Oncology Therapeutic Area Unit, Takeda. "Robust, accurate and timely testing is crucial to enable oncologists to make informed treatment decisions so that advanced cancer patients receive the optimal therapy for their disease."
Foundation Medicine’s proven portfolio of FDA-approved comprehensive genomic profiling tests offer physicians both blood- and tissue-based testing options for detecting genomic alterations that help guide personalized treatment decisions. As companion diagnostics, FoundationOneCDx and FoundationOneLiquid CDx allow oncologists to identify patients who may be appropriate for FDA-approved targeted therapies. Through this collaboration, FoundationOne CDx and FoundationOne Liquid CDx will be developed for use with Takeda’s therapies.
"We’re proud to partner with Takeda on this important journey to allow more lung cancer patients to have access to genomic testing to inform personalized treatment decisions," said Cindy Perettie, Chief Executive Officer at Foundation Medicine. "Takeda shares our patient-centric approach to research and development and mission to advance personalized cancer care. This collaboration leveraging our portfolio of FDA-approved genomic tests will accelerate our shared vision and make precision medicine a reality for more patients."
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 311 genes, including rearrangements and copy number losses in BRCA1 and BRCA2, and is a companion diagnostic to identify patients who may benefit from treatment with specific targeted 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 available. For the complete label, including companion diagnostic indications and complete risk information, please visit www.F1LCDxLabel.com.
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 View Source
About Mobocertinib (TAK-788)
Mobocertinib is a potent, small-molecule TKI specifically designed to selectively target epidermal growth factor receptor (EGFR) and human EGFR2 (HER2) Exon 20 insertion mutations. In 2019, the U.S. FDA granted mobocertinib Orphan Drug Designation for the treatment of lung cancer with HER2 mutations or EGFR mutations including Exon20 insertion+ metastatic non-small cell lung cancer (mNSCLC). In April 2020, mobocertinib received Breakthrough Therapy Designation from the FDA for patients with EGFR Exon20 insertion+ mNSCLC whose disease has progressed on or after platinum-based chemotherapy. The mobocertinib development program began in the NSCLC population and is expected to expand to additional underserved populations in other tumor types. Mobocertinib is an investigational drug for which efficacy and safety have not been established.
About ALUNBRIG (brigatinib)
ALUNBRIG is a potent and selective next-generation tyrosine kinase inhibitor (TKI) that was designed to target anaplastic lymphoma kinase (ALK) molecular alterations.
ALUNBRIG is approved in the U.S. and European Union (EU) as a first-line treatment for patients with ALK-positive (ALK+) metastatic non-small cell lung cancer (mNSCLC) previously not treated with an ALK inhibitor. ALUNBRIG is also approved in more than 40 countries, including the U.S., Canada and the EU, for the treatment of people living with ALK+ mNSCLC who have taken the medicine crizotinib, but their NSCLC has worsened or they cannot tolerate taking crizotinib.