AstraZeneca PLC said yesterday it was working with Swiss drug giant Roche Holding AG and Dutch provider of sample and assay technologies for molecular diagnostics, Qiagen NV, to develop companion diagnostic tests to support its portfolio of lung cancer medicines.
IRESSA, an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor blocks the signals from the EGFR, that lead to tumour growth.
EGFR, a protein is found in abnormally high levels on the surface of many types of cancer cells, especially in non-small cell lung cancer (NSCLC) cells.
Using Qiagen's diagnostic test, doctors would be able to identify patients with the EGFR mutation, and therefore candidates with the best treatment prospects with IRESSA, through a blood test.
In the main method currently used for assessing EGFR mutation status tumour tissue is collected by needle biopsy or during resection.
A highly-sensitive assay is used in Qiagen's test to detect EGFR mutations in the small fragments of circulating tumour DNA (ctDNA) in plasma taken from patients' blood samples.
Reliable identification of EGFR mutation status had been demonstrated in the test using samples from the Phase IV 'IRESSA follow up measure' (IFUM) study.
This collaboration forms part of a long-standing relationship between AstraZeneca and Qiagen, which are now seeking seeking approval from the European Medicines Agency for the ctDNA test, as a companion diagnostic for IRESSA.
In a press release today Qiagen announced the collaboration agreement with AstraZeneca Plc for the co-development and commercialisation 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 analyses 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 US 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.