Fast-tracking clinical readiness of test to support identification of patients eligible for novel Novartis PI3K inhibitor BYL719 (alpelisib)
Germantown, Maryland, and Hilden, Germany, December 6, 2018 – QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced that a clinical development program is underway with Novartis to bring to market a molecular test as a companion diagnostic to guide the use of the investigational compound BYL719 (alpelisib) in combination with fulvestrant for men and postmenopausal women living with PIK3CA mutated hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer.
The Novartis drug candidate is in late-stage development, and QIAGEN expects to provide its companion diagnostic to clinical laboratory partners who will then be ready to offer immediate access to the test upon potential regulatory approvals of BYL719 and QIAGEN’s test.
Novartis has completed a Phase III clinical trial (SOLAR), testing BYL719 in combination with fulvestrant for patients with PIK3CA mutated HR+/HER2- advanced breast cancer.
QIAGEN’s companion diagnostic for PIK3CA mutations will provide a complete Sample to Insight workflow, from DNA extraction to detection of the clinically relevant mutations and final reporting. The test will be clinically validated for analysis of both FFPE tissue and liquid biopsy samples using plasma. The companion diagnostic will run on the Rotor-Gene Q MDx cycler, which is part of the modular QIAsymphony family of automation solutions, established in numerous pathology laboratories worldwide.
“There is an unmet medical need for improved treatment options in patients living with HR-positive, HER2-negative advanced breast cancer with a PIK3CA mutation. Currently, no FDA-approved drugs are available on the U.S. market to specifically target this mutation in breast cancer. Under our master collaboration agreement with Novartis, we are fast-tracking the development of a companion diagnostic for BYL719 to help close this gap,” said Jonathan Arnold, Vice President and Head of Oncology and Precision Diagnostics for QIAGEN. “The new QIAGEN therascreen test will provide clinically relevant information to aid physicians in choosing which patients to treat with BYL719. The test will be launch-ready for patient testing on “day one” if approved by the FDA, in collaboration with a leading molecular pathology lab.”
Mutations of the PIK3CA gene are found in many types of cancer, including breast. The PIK3CA variants alter the body’s protein signaling and, in combination with other gene mutations, may lead to uncontrolled proliferation of cells and development of cancer. BYL719, a phosphatidylinositol 3-kinase (PI3K) inhibitor, targets signaling pathways and inhibits the activation of the PI3K signaling pathway. This may result in inhibition of tumor cell growth and survival in susceptible tumor cell populations.
Building on the U.S. Food and Drug Administration’s modernized regulatory approach to advanced diagnostics, QIAGEN is building a network of collaborations to accelerate the availability of innovative companion diagnostics that enable precision medicine for cancer patients.
QIAGEN is a pioneer in Personalized Healthcare and the global leader in collaborations with pharmaceutical and biotechnology companies to co-develop and commercialize companion diagnostics, which detect genetic abnormalities to provide insights that guide clinical decision-making on the use of drugs in diseases such as cancer. QIAGEN is working under master collaboration agreements with more than 25 pharmaceutical companies to develop companion diagnostic tests for their drug candidates. QIAGEN expects more than 5 FDA submissions and / or U.S. launches until the end of 2018.
QIAGEN N.V., a Netherlands-based holding company, is the leading global provider of Sample to Insight solutions that enable customers to gain valuable molecular insights from samples containing the building blocks of life. Our sample technologies isolate and process DNA, RNA and proteins from blood, tissue and other materials. Assay technologies make these biomolecules visible and ready for analysis. Bioinformatics software and knowledge bases interpret data to report relevant, actionable insights. Automation solutions tie these together in seamless and cost-effective workflows. QIAGEN provides solutions to more than 500,000 customers around the world in Molecular Diagnostics (human healthcare), Applied Testing (forensics, veterinary testing and food safety), Pharma (pharma and biotech companies) and Academia (life sciences research). As of September 30, 2018, QIAGEN employed approximately 4,900 people in over 35 locations worldwide. Further information can be found at http://www.qiagen.com.
Certain statements contained in this press release may be considered forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended. To the extent that any of the statements contained herein relating to QIAGEN's products, collaborations markets, strategy or operating results, including without limitation its expected adjusted net sales and adjusted diluted earnings results, are forward-looking, such statements are based on current expectations and assumptions that involve a number of uncertainties and risks. Such uncertainties and risks include, but are not limited to, risks associated with management of growth and international operations (including the effects of currency fluctuations, regulatory processes and dependence on logistics), variability of operating results and allocations between customer classes, the commercial development of markets for our products to customers in academia, pharma, applied testing and molecular diagnostics; changing relationships with customers, suppliers and strategic partners; competition; rapid or unexpected changes in technologies; fluctuations in demand for QIAGEN's products (including fluctuations due to general economic conditions, the level and timing of customers' funding, budgets and other factors); our ability to obtain regulatory approval of our products; difficulties in successfully adapting QIAGEN's products to integrated solutions and producing such products; the ability of QIAGEN to identify and develop new products and to differentiate and protect our products from competitors' products; market acceptance of QIAGEN's new products and the integration of acquired technologies and businesses. For further information, please refer to the discussions in reports that QIAGEN has filed with, or furnished to, the U.S. Securities and Exchange Commission (SEC).