Date: 2014-07-28
Type of information: Development agreement
Compound: liquid biopsy-based companion diagnostic to be paired with Iressa®
Company: AstraZeneca (UK) Qiagen (The Netherlands)
Therapeutic area: Cancer - Oncology
Type agreement: development
Action mechanism:
Disease: non-small cell lung cancer
Details: * On July 28, 2014, Qiagen announced a collaboration agreement with AstraZeneca for the co-development and commercialization of a liquid biopsy-based companion diagnostic to be paired with Iressa®, AstraZeneca’s targeted therapy for non-small cell lung cancer (NSCLC). The project builds on a master framework agreement signed by both companies in 2013 and aims to develop and market a novel Qiagen companion diagnostic that analyzes plasma samples to assess EGFR mutation status in NSCLC patients. The assay will be designed to guide the treatment of NSCLC patients with Astra Zeneca’s oral monotherapy anti-cancer treatment when tumour tissue is not available. Qiagen already offers the therascreen EGFR RGQ PCR Kit (therascreen EGFR test) as a tissue-based companion diagnostic for lung cancer patients, which was approved in the U.S. by the FDA in July 2013 and in China in May 2014. The companies will collaborate to create a new companion diagnostic for Iressa® based on liquid biopsy samples from NSCLC patients, rather than requiring invasive surgical collection of tissue samples. Data from several studies, including the IFUM Study (Iressa® Follow-up Measure) presented at the “World Lung 2013” conference, provided evidence of the ability to assess the EGFR status of advanced lung cancer patients using blood / plasma samples. This breakthrough provides hope for patients for whom surgical biopsy is not an option by enabling them to have their EGFR mutation status assessed using a less invasive method. Iressa® is an epidermal growth factor receptor-tyrosine kinase (EGFR-TK) inhibitor that acts to block signals for cancer cell growth and survival. Certain EGFR gene mutations occur in a significant number of lung cancers, and these mutation-positive tumours are particularly sensitive to IRESSA. Qiagen and AstraZeneca plan to develop a test that detects 21 EGFR mutations to identify patients most likely to benefit from the therapy, adapting Qiagen technologies from the FDA-approved therascreen® EGFR RGQ PCR Kit. The new test kit is planned to run onQiagen\'s Rotor-Gene Q system, a member of the QIAsymphony family of automated instruments.
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