Qiagen has announced that a clinical development programme 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 US 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 signalling 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 signalling pathways and inhibits the activation of the PI3K signalling pathway. This may result in inhibition of tumour cell growth and survival in susceptible tumour cell populations.