Healthcare Industry News:  non-small cell lung cancer 

Diagnostics Oncology Regulatory

 News Release - March 25, 2020

ArcherDX Receives Approval for Archer(R)MET Companion Diagnostic for TEPMETKO(R) (Tepotinib) in Advanced Non-Small Cell Lung Cancer in Japan

BOULDER, Colo., March 25, 2020 -- (Healthcare Sales & Marketing Network) -- ArcherDX, Inc., today announced that its ArcherMET companion diagnostic (CDx) has been approved by the Japanese Ministry of Health, Labour and Welfare (MHLW) and the Pharmaceutical Medical Devices Agency (PMDA) to detect MET exon 14 (METex14) skipping alterations in tissue (RNA) and liquid biopsy (ctDNA) from patients with advanced non-small cell lung cancer (NSCLC) for consideration for treatment with Merck KGaA, Darmstadt, Germany's oral MET inhibitor, TEPMETKO®* (tepotinib). ArcherMET is the first and only CDx to be approved for the detection of MET gene alterations and it allows for testing of blood and tissue samples. TEPMETKO is the first approved MET inhibitor in Japan, and is indicated for the treatment of unresectable, advanced or recurrent non-small cell lung cancer with METex14 skipping alterations. TEPMETKO is administered orally once daily. Please see recent news about TEPMETKO here.

Merck KGaA, Darmstadt, Germany launched a strategic partnership with ArcherDX in 2018 to develop a CDx featuring both liquid and tissue biopsy capabilities, including a program to identify METex14 skipping alterations among patients with advanced NSCLC.

"We're delighted that the Japan approval of ArcherMET as a companion diagnostic for TEPMETKO means NSCLC patients will have access to Merck KGaA, Darmstadt, Germany's targeted therapy with demonstrated efficacy," said Jason Myers, Ph.D., Chief Executive Officer and co-founder, ArcherDX. "This approval is the most recent highlight from our ongoing partnership with Merck KGaA, Darmstadt, Germany, and demonstrates our ability to deliver highly accurate and precise companion diagnostics that enable our global partners to accelerate access to therapies for patients in need and democratize personalized medicine."

"With the approval of TEPMETKO and its companion diagnostic, ArcherMET in Japan, NSCLC patients harboring MET exon 14 skipping alterations can now be identified and treated with a targeted approach and precision that was not previously possible," said Zhen Su, M.D., MBA, Senior Vice President & Head of Global Franchise Oncology, Merck KGaA, Darmstadt, Germany. "We are excited that through our partnership with ArcherDX, we are able to address this unmet medical need with a precision approach and deliver important progress for patients living with this aggressive form of lung cancer."

Lung cancer is one of the most common types of cancer worldwide, with approximately 2 million cases diagnosed in 2018.i It is also the second most common type of cancer in Japan. Alterations of the MET signaling pathway, such as METex14 skipping alterations, are found in various cancer types, including 3% to 5% of NSCLC cases, and correlate with aggressive tumor behavior and poor clinical prognosis.ii,iii,iv

*The brand name TEPMETKO® is not approved for use outside of Japan.

About ArcherDX

ArcherDX is a leading genomic analysis company democratizing precision oncology through a suite of products and services that are highly accurate, personal, actionable and easy to use in local settings. Our Archer® platform, with our proprietary Anchored Multiplex PCR (AMP™) chemistry at the core, has enabled us to develop industry-leading products and services to optimize therapy and enable cancer monitoring across sample types. We develop and commercialize research use only (RUO) products, are developing in vitro diagnostic (IVD) products, and offer services that meet the unique needs of our customers and their clinical applications. Our RUO product portfolio consists of VaiantPlex®, FusionPlex®, LiquidPlex™ and Immunoverse™, which we collectively refer to as ArcherPlex™. STRATAFIDE and Personalized Cancer Monitoring (PCM) are IVD products currently in development and have both received Breakthrough Device Designation from the FDA. ArcherDX is headquartered in Boulder, Colorado. Learn more at and follow @ArcherDXInc on Twitter, Facebook and LinkedIn.

Forward-Looking Statements

This press release may contain forward-looking statements that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements contained in this press release other than statements of historical fact, are forward-looking statements. The words "believe," "may," "will," "estimate," "continue," "anticipate," "intend," "plan," "expect," "predict," "potential," "opportunity," "goals," or "should," and similar expressions are intended to identify forward-looking statements. These forward-looking statements include, among others, statements regarding the impact of the Japan approval of ArcherMET as a companion diagnostic for TEPMETKO on patients. Such statements are based on management's current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors. ArcherDX has based these forward-looking statements largely on its current expectations and projections about future events and trends. These forward-looking statements are subject to a number of risks, uncertainties and assumptions. Moreover, ArcherDX operates in a competitive and rapidly changing environment. New risks emerge from time to time. It is not possible for its management to predict all risks, nor can it assess the impact of all factors on its business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements it may make. ArcherDX undertakes no obligation to revise or publicly release the results of any revision to such forward-looking statements, except as required by law. Given these risks and uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements. All forward-looking statements are qualified in their entirety by this cautionary statement.

i Bray F, et al. CA Cancer J Clin. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. 2018;68(6):394–424. PMID:30207593

ii Reungwetwattana T, et al. Lung Cancer 2017;103:27-37.

iii Mo HN, et al. Chronic Dis Transl Med 2017; 3(3):148-153.

iv Lutterbach B, et al. Cancer Res 2007;67:2081–8.

Source: ArcherDX

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