"Real World" Data Support Use of Blood Test for EGFR Mutation in Advanced NSCLC

GENEVA, April 17, 2015 /PRNewswire/ --

ASSESS shows plasma circulating tumour DNA (ctDNA) testing for EGFR mutation is a viable alternative to tumour biopsy 

IGNITE supports value of EGFR mutation testing in all patients with advanced NSCLC 

AstraZeneca today presented results from two key studies showing the effectiveness of plasma circulating tumour DNA (ctDNA) testing for epidermal growth factor receptor (EGFR) mutation status in newly diagnosed patients with advanced non-small cell lung cancer (NSCLC) in clinical practice.^[1],[2]

Data from the studies - ASSESS and IGNITE - were reported at the European Lung Cancer Conference (ELCC) 2015 in Geneva, Switzerland.

ASSESS shows concordance between ctDNA testing and tumour biopsy results 

ASSESS - the first large scale "real world" study comparing tumour biopsy with ctDNA testing for EGFRm in advanced NSCLC - showed concordance between results obtained with the two techniques.^[1] In 1162 matched samples,  there was good agreement between tumour and plasma test results for EGFRm status (89%, 95%CI 87-91). Plasma testing identified approximately half of patients with EGFRm found by tumour testing, and some patients with EGFR mutations missed by tumour testing were identified as EGFRm by plasma testing.^[1] Failure to identify EGFR mutations with tumour testing was associated with use of less sensitive methodology.

Dr Martin Reck MD, PhD, Department of Thoracic Oncology, Lungen Clinic Grosshansdorf, Germany, explained that the study confirms that tumour testing is currently the best way of identifying patients with EGFR mutations but also shows the importance of using sensitive testing methods.

"ASSESS shows that plasma ctDNA testing is a viable alternative to tumour testing when tumour samples are unavailable, provided that optimal DNA extraction and appropriately sensitive methodology are used," he concluded. "It also showed that improvements can still be made in tumour testing, to ensure all patients with an EGFR mutation are identified and given appropriate treatment."

"Real world" value of EGFR mutation testing in all patients with advanced NSCLC 

Results of the IGNITE study presented at ELCC 2015 support "real world" EGFR mutation testing in all patients with advanced NSCLC.^[2] Using tissue and plasma ctDNA testing in over 3300 patients enrolled from Russia and a number of countries across Asia Pacific including China, researchers found that EGFR mutation frequency in patients with advanced NSCLC of adenocarcinoma (ADC) histology was higher versus non-ADC histology. But they suggested that levels of mutations in non-ADC were sufficient to make testing all patients worthwhile.^[2]

The success and ongoing value of "real world" studies like ASSESS and IGNITE underline AstraZeneca's position in pioneering the role of diagnostics in EGFR mutation detection.  

In Europe, ctDNA assessment of EGFRm status in patients where a tumour sample is not evaluable was recently approved for use with IRESSA^® (gefitinib), making it the first EGFR tyrosine kinase inhibitor for which ctDNA testing has been included in the label.^[3]  In February 2015, the China Food and Drug Administration (CFDA) approved an update to the IRESSA® (gefitinib) label to include blood based diagnostics when tumour tissue is not evaluable.  

NOTES TO EDITORS 

About IRESSA 

IRESSA is a targeted monotherapy for the treatment of patients with advanced or metastatic epidermal growth factor receptor mutation positive (EGFRm) non-small cell lung cancer (NSCLC). IRESSA acts by inhibiting the tyrosine kinase enzyme in the EGFR, thus blocking the transmission of signals involved in the growth and spread of tumours. EGFR mutations occur in approximately 10-15 percent of NSCLC patients in Europe and 30-40 percent of NSCLC patients in Asia.

IRESSA was launched in 2002 and is now approved in 90 countries worldwide.

In the US, AstraZeneca is working with Qiagen to develop a companion diagnostic test to guide the use of IRESSA in the treatment of patients with advanced NSCLC.

In Europe, the collaboration between AstraZeneca and Qiagen has resulted in IRESSA becoming the first EGFR tyrosine kinase inhibitor to have a European label allowing the use of circulating tumour DNA (ctDNA) obtained from a blood sample, to be used for the assessment of EGFR mutation status in those patients where a tumour sample is not an option.

About AstraZeneca 

AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of cardiovascular, metabolic, respiratory, inflammation, autoimmune, oncology, infection and neuroscience diseases. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit: http://www.astrazeneca.com.

References 

^[1]Reck M, et al. Investigating the utility of circulating-free tumour-derived DNA (ctDNA) in plasma for the detection of epidermal growth factor receptor (EGFR) mutation status in European and Japanese patients (pts) with advanced non-small-cell lung cancer (NSCLC): ASSESS study. Presented at the European Lung Cancer Conference (ELCC) Annual Meeting, Geneva; 15-18 April 2015.

^[2]Han B, et al. Determining the prevalence of EGFR mutations in Asian and Russian patients (pts) with advanced non-small-cell lung cancer (aNSCLC) of adenocarcinoma (ADC) and non-ADC histology: IGNITE study.

^[3]IRESSA EPAR Product Information. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_Product_Information/human/001016/WC500036358 Accessed February 2015.