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

PR60195

GENEVA, Apr.18, 2015 / PRN=KYODO JBN/ --

- 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/WC500036358

Accessed February 2015.

SOURCE: AstraZeneca