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.
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)20 7075 3186
|
Emily Denney
+44 (0)20 7304 5034
Chris Major
+44 (0)20 7304 5028
|
|
Mike Rance
+44 (0)20 7304 5050
Jonathan Hunt
+44 (0)20 7304 5087
|
|
|
- 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.
- 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
|
Iressa is a trademark, property of the AstraZeneca group of companies.