Predictor of Response to IRESSA(TM) (Gefitinib) Investigated in First Prospective Biomarker Study

Atlanta (ots/PRNewswire) -

- Study Provides Further Evidence That High EGFR Gene Copy Number Correlates With Increased Response to IRESSA in Advanced Non-Small Cell Lung Cancer (NSCLC) Patients

Data announced today at the 42nd American Society of ClinicalOncology (ASCO) Annual Meeting further advanced the understanding ofthe importance of biomarkers in the treatment of non-small cell lungcancer (NSCLC). Data presented from the ONCOBELL study, the firstprospective biomarker study to report in NSCLC, demonstrate thatresponse to treatment with IRESSA(TM) (gefitinib) amongst patientswho had a high EGFR gene copy number, as identified by fluorescencein situ hybridization (FISH), or EGFR FISH positive, was 68%.(1) Thestudy included patients receiving IRESSA as their first or subsequenttreatment. These data provide further evidence to suggest that highEGFR gene copy number is a strong predictor of response to treatmentwith IRESSA for advanced NSCLC.

Of the 42 patients enrolled in the ONCOBELL trial, a phase IIstudy designed to evaluate the effects of IRESSA in patients withadvanced or metastatic NSCLC who were never smokers and/or EGFR FISHpositive/phosphor-akt (pAKT) positive, 47% experienced an objectiveresponse (1 complete response; 19 partial responses).(1) However,when specifically assessing those patients who were identified asbeing EGFR FISH positive (n=25), 68% of patients experienced aresponse,(1) leading the study authors to conclude that IRESSA is a"highly effective" treatment in these patients.

Lead investigator of the ONCOBELL trial, Professor FedericoCappuzzo, MD, Ospedale Bellaria Hospital, Bologna, Italy, stated,"These data are very exciting because they suggest that we canidentify, with a greater degree of certainty, those patients who maybe more likely to respond to treatment with IRESSA." ProfessorCappuzzo went on, "This study indicates that, by identifying thisbiological marker in patients prior to treatment, we can ensure theyare prescribed a therapy they are likely to respond to. This shouldbe welcome news to both clinicians and patients."

These new findings provide further support to the outcomes of ananalysis of 370 tumour samples evaluated for EGFR gene copy numberfrom the ISEL study in which approximately one third (31%, 114patients) were found to have EGFR FISH positive tumours.(2) TheseEGFR FISH positive patients appeared to achieve better survivaloutcomes and a higher objective response rate when treated withIRESSA, compared with placebo.

Further data also presented today from an analysis of 190 patientswith advanced NSCLC suggest response to platinum based chemotherapywas not associated with EGFR FISH or HER2 FISH status.(3) Althoughthese data are investigational, in conjunction with evidence fromprevious studies,(4,5) they suggest that EGFR FISH positive statusmay be more predictive in identifying patients who are likely tobenefit from treatment with EGFR-TKI therapy, such as IRESSA, asopposed to identifying those likely to benefit from chemotherapy.

Dr Nick Botwood, Worldwide Medical Director IRESSA, AstraZeneca,commented, "These data are very interesting. With the growing volumeof evidence about the predictive value of a range of biomarkers, weare beginning to be able to define more clearly which biomarkerscould be used to predict response to therapy. In the future, this mayallow clinicians to tailor treatment to a specific patient's needs.AstraZeneca continues to evaluate the role of biomarkers inidentifying which patients will respond to IRESSA in ongoing trials."

IRESSA is approved in 36 countries for the treatment of advanced NSCLC.

Notes to Editors:

'IRESSA' is a trademark, the property of the AstraZeneca group of companies.

AstraZeneca is a major international healthcare business engagedin the research, development, manufacture and marketing ofprescription pharmaceuticals and the supply of healthcare services.It is one of the world's leading pharmaceutical companies withhealthcare sales of $23.95 billion and leading positions in sales ofgastrointestinal, cardiovascular, neuroscience, respiratory, oncologyand infection products. AstraZeneca is listed in the Dow JonesSustainability Index (Global) as well as the FTSE4Good Index.

For more information about AstraZeneca, please visit: www.astrazeneca.com


1. Cappuzzo F, et al. Clinical and biological effects of gefitinib in EGFR FISH positive/phospho-akt positive or never smoker non-small cell lung cancer (NSCLC): Preliminary results of the ONCOBELL trial. ASCO 2006, Abs. 7023.

2. Hirsch FR, et al. Molecular Analysis of EGFR Gene Copy Number, EGFR Expression and Akt Activation Status in Advanced Non-small-cell Lung Cancer (aNSCLC) Treated with Gefitinib or Placebo (ISEL trial). AACR-NCI-EORTC 2005, Abs. A268.

3. Toschi L, et al. Tyrosine kinase inhibitors and chemotherapy target different non-small cell lung cancer (NSCLC) patient populations. ASCO 2006, Abs. 7111.

4. Thatcher N, Chang A, Parikh P, et al. Gefitinib plus best supportive care in previously treated patients with refractory advanced non-small-cell lung cancer: results from a randomised, placebo-controlled, multicentre study (Iressa Survival Evaluation in Lung Cancer). The Lancet 2005;366(9496):1527-37.

5. Tsao MS, et al. Erlotinib in Lung Cancer - Molecular and Clinical Predictors of Outcome. New England Journal of Medicine 2005;353:133-144.

Originaltext: AstraZenecadigital press kits: http://presseportal.de/story.htx?firmaid=18044press kits via RSS: feed://presseportal.de/rss/pm_18044.rss2

Janet Milton-Edwards, AstraZeneca, Tel: +44-1625-515-275,Mobile: +44-7990-640-119, janet.milton-edwards@astrazeneca.com;Odette England, AstraZeneca, Mobile: +44-7743-927-226,odette.england@astrazeneca.com


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Predictor of Response to IRESSA(TM) (Gefitinib) Investigated in First Prospective Biomarker Study