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.
SOURCE AstraZeneca