Theresa Catharina de Góes Campos

  De: PR Newswire Brasil
Assunto: Predictor of Response to IRESSA(TM) (Gefitinib) Investigated in First Prospective Biomarker Study
05 de junho de 2006 12:25 HORALOCAL

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

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

ATLANTA, June 5 /PRNewswire/ -- Data announced today at the 42nd
American Society of Clinical Oncology (ASCO) Annual Meeting further
advanced the understanding of the importance of biomarkers in the
treatment of non-small cell lung cancer (NSCLC). Data presented from
the ONCOBELL study, the first prospective biomarker study to report
in NSCLC, demonstrate that response to treatment with IRESSA(TM)
(gefitinib) amongst patients who had a high EGFR gene copy number, as
identified by fluorescence in situ hybridization (FISH), or EGFR FISH
positive, was 68%.(1) The study included patients receiving IRESSA as
their first or subsequent treatment. These data provide further
evidence to suggest that high EGFR gene copy number is a strong
predictor of response to treatment with IRESSA for advanced NSCLC.
Of the 42 patients enrolled in the ONCOBELL trial, a phase II study
designed to evaluate the effects of IRESSA in patients with advanced
or metastatic NSCLC who were never smokers and/or EGFR FISH
positive/phosphor-akt (pAKT) positive, 47% experienced an objective
response (1 complete response; 19 partial responses).(1) However,
when specifically assessing those patients who were identified as
being EGFR FISH positive (n=25), 68% of patients experienced a
response,(1) leading the study authors to conclude that IRESSA is a
"highly effective" treatment in these patients.
Lead investigator of the ONCOBELL trial, Professor Federico Cappuzzo,
MD, Ospedale Bellaria Hospital, Bologna, Italy, stated, "These data
are very exciting because they suggest that we can identify, with a
greater degree of certainty, those patients who may be more likely to
respond to treatment with IRESSA." Professor Cappuzzo went on, "This
study indicates that, by identifying this biological marker in
patients prior to treatment, we can ensure they are prescribed a
therapy they are likely to respond to. This should be welcome news to
both clinicians and patients."
These new findings provide further support to the outcomes of an
analysis of 370 tumour samples evaluated for EGFR gene copy number
from the ISEL study in which approximately one third (31%, 114
patients) were found to have EGFR FISH positive tumours.(2) These
EGFR FISH positive patients appeared to achieve better survival
outcomes and a higher objective response rate when treated with
IRESSA, compared with placebo.
Further data also presented today from an analysis of 190 patients
with advanced NSCLC suggest response to platinum based chemotherapy
was not associated with EGFR FISH or HER2 FISH status.(3) Although
these data are investigational, in conjunction with evidence from
previous studies,(4,5) they suggest that EGFR FISH positive status
may be more predictive in identifying patients who are likely to
benefit from treatment with EGFR-TKI therapy, such as IRESSA, as
opposed 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 volume
of evidence about the predictive value of a range of biomarkers, we
are beginning to be able to define more clearly which biomarkers
could be used to predict response to therapy. In the future, this may
allow clinicians to tailor treatment to a specific patient's needs.
AstraZeneca continues to evaluate the role of biomarkers in
identifying which patients will respond to IRESSA in ongoing trials."
IRESSA is approved in 36 countries for the treatment of advanced

Notes to Editors:

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

AstraZeneca is a major international healthcare business engaged in
the research, development, manufacture and marketing of prescription
pharmaceuticals and the supply of healthcare services. It is one of
the world's leading pharmaceutical companies with healthcare sales of
$23.95 billion and leading positions in sales of gastrointestinal,
cardiovascular, neuroscience, respiratory, oncology and infection
products. AstraZeneca is listed in the Dow Jones Sustainability Index
(Global) as well as the FTSE4Good Index.

For more information about AstraZeneca, please visit:


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.
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;

SOURCE AstraZeneca
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+44-7990-640-119,, or Odette
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