AstraZeneca PLC
19 August 2002
LUNG CANCER TRIAL RESULTS SHOW NO IMPROVEMENT FOR THE COMBINED TREATMENT OF
IRESSA (ZD1839) WITH STANDARD PLATINUM-BASED CHEMOTHERAPY
AstraZeneca Continues Seeking Approvals for Iressa
Monotherapy in Lung Cancer
AstraZeneca announced today top-line results of the recently completed INTACT
trials. These results confirm that the trials were robust and well designed, but
demonstrate that 'Iressa' (ZD1839) does not provide improvement in survival when
added to standard platinum-based chemotherapy versus chemotherapy alone in
advanced non-small cell lung cancer (NSCLC). Further analyses are underway and
the data will be presented at the European Society for Medical Oncology (ESMO)
in October 2002.
'This outcome is in contrast to the good results seen in the use of 'Iressa' as
monotherapy and points to the direction for future work in this breakthrough
area of cancer treatment,' said Brent Vose, Vice President, Oncology Therapy
Area. 'AstraZeneca will continue to pursue world wide approvals for monotherapy
use of 'Iressa' in NSCLC and explore its full potential in lung cancer and in
other tumour types.'
'Iressa', a once daily, oral tablet, is the first in a new class of anti-cancer
drugs, known as Epidermal Growth Factor Receptor (EGFR) tyrosine kinase
inhibitors, to become commercially available. The monotherapy data from the
IDEAL 1 and 2 trials have confirmed 'Iressa' as an effective treatment with a
favourable tolerability profile for many patients with advanced NSCLC. These
data formed the basis of the company's regulatory submissions in several
countries including Japan, where 'Iressa' has already been approved, and in the
United States, where a review is underway. The company will also pursue similar
monotherapy submissions in all major markets, including Europe.
'Iressa' is currently in Phase II trials for a variety of other solid tumours
including head and neck, colorectal, and breast cancers, and initial data are
encouraging.
Cont...
- 2 -
The company's guidance on earnings for 2002 remains unchanged.
A teleconference for financial analysts will be held today at 13:00 (BST). The
numbers for analysts are as follows:
UK: + 44 (0) 800 559 3282
Europe: +353 (0) 233 7012
US: +1 800 310 1961
Back-up: +353 (0) 233 7014
A listen-in facility for journalists will also be available:
UK: +44 (0) 207 075 3186
'Iressa' is a trademark of the AstraZeneca group of companies.
- Ends -
August 19, 2002
Media Enquiries:
Emily Denney, Tel: +44 (0) 207 304 5034
Chris Major, Tel: +44 (0) 207 304 5028
Investor Relations:
Jonathan Hunt, Tel: +44 (0) 207 304 5087
Mike Rance, Tel: +44 (0) 207 304 5050
Notes:
INTACT 1 and 2 ('Iressa' NSCLC Trials Assessing Combination Therapy) were two
randomised Phase III trials, each of over 1,000 patients, designed to evaluate
whether 'Iressa' provides an additional survival benefit when administered in
combination with standard platinum-based chemotherapy in patients with advanced
non-small cell lung cancer (NSCLC).
IDEAL 1 and 2 ('Iressa' Dose Evaluation in Advanced Lung Cancer) showed 'Iressa'
is active as monotherapy, providing objective responses (tumour shrinkage) and
symptomatic benefit in patients with advanced NSCLC who have failed
chemotherapy.
Cont...
- 3 -
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 top five pharmaceutical
companies in the world with healthcare sales of over $16.4 billion and leading
positions in sales of oncology, gastrointestinal, anaesthesia (including pain
management), cardiovascular, central nervous system (CNS) and respiratory
products.
For further information on the Epidermal Growth Factor Receptor and its
potential role in cancer treatment, please visit www.EGFR-INFO.com.
For further information on 'Iressa' and other AstraZeneca cancer therapies,
please visit www.cancerpressoffice.com.
This information is provided by RNS
The company news service from the London Stock Exchange
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