IRESSA(TM) (gefitinib) demonstrates clinical activity in multiple tumour types

IRESSA(TM) (gefitinib) DEMONSTRATES CLINICAL ACTIVITY IN MULTIPLE TUMOUR TYPES AstraZeneca announced today that new data presented at the 39th American Society of Clinical Oncology Annual Meeting in Chicago demonstrate the potential of IRESSA(TM) (gefitinib, ZD1839) to have anti-tumour activity across a broad range of common cancers. Encouraging data from Phase ll trials in advanced colorectal cancer, non-small cell lung cancer (NSCLC), breast cancer and brain cancer support IRESSA's current and future role as an efficacious anti-cancer agent that is generally well tolerated across all tumour types. "Data demonstrating IRESSA's clinical efficacy in advanced NSCLC have now led to approvals in several major markets, "said Brent Vose, Vice President, Oncology Therapy Area. "Today's news that there is further evidence to suggest IRESSA may also provide clinical benefit in additional cancers is encouraging, and we are committed to researching and further developing IRESSA in a number of these disease areas through an extensive clinical trial programme." IRESSA is the first in a new class of anti-cancer drugs known as Epidermal Growth Factor Receptor (EGFR) - Tyrosine Kinase (EGFR-TK) inhibitors and has been approved for the treatment of advanced NSCLC by the U. S. Food and Drug Administration, the Australian Therapeutic Goods Administration, and the Japanese Ministry of Health, Labour and Welfare. IRESSA is currently undergoing regulatory review with several other regulatory authorities worldwide for the treatment of advanced NSCLC. Since its launch in Japan in July 2002, IRESSA has recorded $86 million in sales. The worldwide market for lung cancer is currently worth approximately $1.6 billion, the majority of which is accounted for by NSCLC, and is expected to grow to $8 billion by 2011. Advanced colorectal cancer and breast cancer each represent additional multi- billion dollar potential markets. COLORECTAL CANCER Encouraging early phase II data indicate that the addition of IRESSA to the triple combination chemotherapy known as FOLFOX* for advanced colorectal cancer could lead to improvements in clinical outcomes. Data demonstrated that 75 per cent of previously untreated colorectal cancer patients achieved a partial response ¯where their tumour had shrunk by at least half ¯ when they received IRESSA in combination with FOLFOX. Additionally, 29 per cent of patients whose cancer progressed on prior chemotherapy responded when given FOLFOX plus IRESSA. Previous studies have shown that FOLFOX alone gives an overall response rate of approximately 50 per cent in previously untreated patients, while for patients who have received prior therapy; the response rate is around 9 per cent. The data also showed the combination with IRESSA to be generally well tolerated, with the most commonly reported side effects being diarrhoea and nausea. Colorectal cancer is the second most common cancer in the world. Non Small Cell Lung Cancer (NSCLC) New findings from the IDEAL** 2 study demonstrate that patients, with advanced NSCLC cancer who had failed at least two prior treatments, experienced improvement in the debilitating symptoms of their cancer when taking IRESSA monotherapy once daily, and were more likely to achieve better outcomes in terms of their overall survival rates and tumour shrinkage if their symptoms improved. A separate retrospective analysis of NSCLC patients who received IRESSA once daily on a compassionate use basis, also reveals that those who had failed at least one previous chemotherapy treatment achieved good disease control. Out of 72 evaluable patients, 43 per cent achieved disease control, where their cancer had stopped progressing or they experienced tumour shrinkage. IRESSA also demonstrated an acceptable safety profile with the most frequent side effects observed being skin rash and diarrhoea. BREAST CANCER Two Phase ll trials in patients with advanced breast cancer who had failed previous treatment options confirm previously reported clinical activity of monotherapy IRESSA in recurrent breast cancer. The first study assessed anti-tumour activity and tolerability of IRESSA in 31 patients with advanced breast cancer. Ten patients (32 per cent) experienced stable disease (SD) for at least three months, including six patients who had SD for more than 4 months and three patients for more than 6 months. IRESSA was generally well tolerated with the majority of adverse events being mild (grade 1/2). In a second study of 33 patients with advanced breast cancer, IRESSA was also generally well tolerated and had anti-tumour activity in patients with ER-negative tumours and ER-positive tumours, who had been treated with tamoxifen but had developed resistance to the drug. BRAIN CANCER Two studies further suggest IRESSA may have anti-tumour activity in several types of brain cancers, including glioblastoma multiforme (GBM), one of the most common but aggressive and fatal forms of primary brain tumours. In the first study, 51 patients ¯ diagnosed with glioblastomas and who had received previous treatment ¯ were treated with IRESSA. Of these, one patient achieved a partial response and 22 (43 per cent) achieved stable disease where their cancer stopped progressing. In a second study, of 50 patients, five patients achieved a partial response (four patients had glioblastoma and one patient had anaplastic oligodendroglioma), when treated with IRESSA after their tumours had progressed following radiation therapy. IRESSA's tolerability profile was consistent with that seen in other trials with the most common side effects being skin rash, fatigue and diarrhoea. Media Enquiries: Staffan Ternby, 08-553 261 07, 070/557 43 00 Emily Denney, +44 (0) 207 304 5034 Louise Marland, Global PR Manager, Oncology, +44 (0) 7900 607794 Investor Relations: Staffan Ternby, 08-553 261 07, 070/557 43 00 Mina Blair Robinson, +44 (0) 207 304 5084 Jonathan Hunt, +44 (0) 207 304 5087 Notes to editors IRESSA(TM) is a trademark of the AstraZeneca group of companies. · 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(TM) and lung cancer, please visit www.iressa.com · For further press information regarding IRESSA(TM) and other AstraZeneca cancer therapies, please visit www.cancerpressoffice.com * FOLFOX is a triple combination of oxaliplatin and 5-fluorouracil (5-FU) two cytotoxic chemotherapy agents with leucovorin (folinic acid) ** IDEAL = IRESSA Dose Evaluation in Advanced Lung Cancer ------------------------------------------------------------ This information was brought to you by Waymaker http://www.waymaker.net The following files are available for download: http://www.waymaker.net/bitonline/2003/06/02/20030602BIT00610/wkr0001.doc http://www.waymaker.net/bitonline/2003/06/02/20030602BIT00610/wkr0002.pdf