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Gefitinib (Iressa(TM)) Lung Cancer ISEL Trial Shows no Overall Survival Advantage in a Highly Refractory Population

London (ots/PRNewswire)

AstraZeneca today announced that the
initial analysis of the primary endpoint of Study 709, IRESSA
Survival Evaluation in Lung cancer (ISEL) with 1692 patients has been
conducted, and shows that IRESSA failed to significantly prolong
survival in comparison to placebo in the overall population (HR 0.89,
p=0.11, Median 5.6 vs 5.1 months), or in patients with adenocarcinoma
(HR 0.83, p=0.07, Median 6.3 vs 5.4 months). There was a
statistically significant improvement in tumour shrinkage (objective
response rate), which did not translate into a statistically
significant survival benefit. Prospective subgroup analyses suggested
survival benefits in patients of Oriental origin and in patients who
never smoked.
"The trial was well designed, the data are robust and there is no
methodological explanation for these findings. Full results from ISEL
will be presented in the first half of 2005," commented Professor
Nick Thatcher, Principal Investigator for the ISEL study.
"ISEL was a large well conducted study that demonstrated a similar
objective response rate to that seen in the erlotinib study BR21 but,
disappointingly, this did not result in an overall survival benefit."
commented Dr Alan Barge, Worldwide Medical Director for IRESSA.
"Iressa clearly provides substantial benefits for some patients in
clinical practice and we will be working to better understand this
outcome including evaluation of EGFR expression and other
biomarkers."
AstraZeneca is now actively consulting with Regulatory Authorities
to determine the impact of these data and intends to honour a
commitment to continue to supply IRESSA to any patient receiving the
drug who, in consultation with their physician, wishes to continue
treatment. Patients currently being prescribed IRESSA should continue
to take their medication and should consult their physician about
their ongoing treatment at the first opportunity.
Note to News Editors:
Oriental patients were recruited from a number of countries
including Malaysia, Phillippines, Singapore, Taiwan and Thailand.
The ISEL study investigated the survival benefit of IRESSA 250mg
daily as monotherapy in patients with advanced NSCLC who had failed
one or more lines of chemotherapy and is the largest ever trial
conducted in this population. The split between 2nd and 3rd line
patients was approximately 50/50. Approximately 1,700 patients were
enrolled; the study population was representative of the general
NSCLC population and patients who enrolled were either intolerant of,
or refractory to, their most recent prior chemotherapy regimen.
Lung cancer is the world's biggest cancer killer: according to the
World Health Organisation in 2002, more than 1.3 million new cases
were diagnosed that year and during the same period more than 1.1
million people died from the disease. IRESSA is currently licensed
for treating the most common form of lung cancer, Non-Small Cell Lung
Cancer (NSCLC), which accounts for approximately 80 percent of all
lung cancer cases. More than 210,000 patients have been treated with
IRESSA and it is licensed in more than 30 countries including the US,
Japan, Canada, Australia and Switzerland.
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 over $18.8 billion and leading positions in sales
of gastrointestinal, oncology, cardiovascular, neuroscience and
respiratory products. AstraZeneca is listed in the Dow Jones
Sustainability Index (Global) as well as the FTSE4Good Index.
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