|
|
|
|
De: PR Newswire
Brasil
Para: THERESA CATHARINA DE GÓES CAMPOS
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
NSCLC.
Notes to Editors:
'IRESSA' is a trademark, the property of the
AstraZeneca group of
companies.
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:
www.astrazeneca.com
References
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.
SOURCE AstraZeneca
05/06/2006
CONTACT: Janet Milton-Edwards, +44-1625-515-275,
Mobile:
+44-7990-640-119,
janet.milton-edwards@astrazeneca.com, or Odette
England, Mobile: +44-7743-927-226,
odette.england@astrazeneca.com,
both of AstraZeneca
Web site: http://www.astrazeneca.com
BNED: NG
FONTE: PR NEWSWIRE LATIN AMERICA
CORAL GABLES - MIAMI-US
CONTATOS: USA-MARY D'LEON
BRASIL-NÉLIA GARCIA
TELS: USA:1-305-507-2550/BRASIL:55-21-2132-8461
FAXES: USA:1-305-461-8670/BRASIL:55-21-2132-8469
E-MAILS: nelia_garcia@prnewswire.com.br
mary_dleon@prnewswire.com
PALAVRA-CHAVE: RJ
PALAVRA-CHAVE/RAMO DE ATIVIDADE: SAÚDE
PALAVRA-CHAVE/EMPRESA: ASTRAZENECA
O texto acima, distribuído pela PR Newswire
Brasil, é de inteira responsabilidade de seu
cliente. A utilização deste material não implica
em custo.
|
|
|
|