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

Geneva (ots/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(R) (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(R) (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/WC500036
358 Accessed February 2015.

ots Originaltext: AstraZeneca
Im Internet recherchierbar: http://www.presseportal.de

Contact:
CONTACTS Media Enquiries Gill Hayes +44(0)78-6737-5083
Anthonia Aboyeji +44(0)78-8473-1627