Iressa Study Results

AstraZeneca PLC 20 May 2002 Iressa(TM) Study Results Confirm Efficacy in Advanced Non-small Cell Lung Cancer AstraZeneca announced today that the final phase II results from the pivotal 'Iressa' IDEAL ('Iressa' Dose Evaluation in Advanced Lung Cancer) 1 and 2 studies presented at the American Society of Clinical Oncology (ASCO) 38th Annual Meeting in Orlando, Florida, confirm 'Iressa' as an effective, potential new treatment approach, with a favourable tolerability profile for many patients with advanced non-small cell lung cancer (NSCLC). Additional data on 'Iressa' in patients with recurrent, advanced squamous cell cancer of the head and neck, whose disease has progressed following radiation and/or chemotherapy, will be presented tomorrow (Tuesday, May 21 - announcement to appear on http:// www.astrazeneca.com/ mainnav1/s_news/c_news/ index.html). Taken together, the results from IDEAL 1 and 2, in which more than 400 patients with previously treated advanced NSCLC were treated with 'Iressa', demonstrate consistent anti-tumour activity and potential patient benefits for 'Iressa'. These well-controlled phase II trials were unprecedented in their scope and design to test a novel, molecularly targeted anticancer agent, and AstraZeneca is highly encouraged by the remarkable consistency of effect in these trials, especially in IDEAL 2, where patients had previously failed on multiple cancer treatments. Lung cancer is a leading cause of cancer death for both men and women and the incidence continues to increase world-wide. The five-year relative survival rate for all stages of lung cancer combined is only 15 per cent. The worldwide market for lung cancer is currently worth approximately $1.6 billion, the majority of which is accounted for by NSCLC. 'Iressa' is currently under regulatory approval with the US Food and Drug Administration (FDA) and the Japanese Ministry of Health, Labour and Welfare (MHLW) for the treatment of advanced non-small cell lung cancer following the submission of clinical packages in December 2001 and January 2002. IDEAL Study Results The IDEAL 2 study was a randomised, double-blind, parallel-arm study, designed to evaluate tumour response, disease-related symptom response and the safety profile of 'Iressa' monotherapy. Two hundred and sixteen patients were randomised to receive oral 'Iressa' at either 250mg per day or 500mg per day. All patients in the IDEAL 2 study had locally advanced and/or metastatic NSCLC, and all had previously failed at least two, and as many as five, prior chemotherapy regimens, including platinum-based therapy and docetaxel. One in four patients enrolled in IDEAL 2 had already been treated with four or more chemotherapy treatments, which had ceased to continue to provide benefit. Top line results are as follows: • Tumour response was reported in 11.8 per cent of patients treated with 250mg daily • Symptom response was reported in 43 per cent of all patients and in 95 per cent of patients with tumour response treated with 250mg daily • Median survival of patients treated with 250 mg daily was 6.5 months The IDEAL 1 study also tested the safety and efficacy of 250 mg and 500 mg of 'Iressa', but did so in patients who had previously failed on only one or two cytotoxic regimens. In contrast to IDEAL 2, these patients were not required to be symptomatic at baseline. Final results from the IDEAL 1 study were presented at the ASCO meeting and the top line results are as follows: • Tumour response rate was 18.4 per cent with 250 mg daily • Thirty-four (34) per cent of patients remained progression free after four months • Symptom response was reported in 40 per cent of patients Overall, there was comparable efficacy for both 250 mg/day and 500 mg/day treatment; however, the 500 mg dose caused greater toxicity as measured by the incidence of adverse events and withdrawals due to drug-related adverse events. Additionally, results from IDEAL 1 and 2 provided further confirmation of the favourable safety profile for 'Iressa', with the majority of side effects (diarrhoea and skin rash) reported as mild and reversible. 'Iressa' is leading a new class of anti-cancer drugs known as selective epidermal growth factor receptor (EGFR) inhibitors. This targeted mode of action is different from cytotoxic chemotherapies and 'Iressa' is not causally associated with the same types of side effects such as alopecia, neutropenia or other haematological toxicity. It is administered as a once daily, oral tablet. Within the cell, 'Iressa' targets and blocks signalling pathways that are implicated in the growth and survival of cancer cells. These pathways appear to play a major role in the growth of many solid tumours; therefore, 'Iressa' may have therapeutic potential in a broad range of common cancers. 'Iressa' is a trademark of the AstraZeneca group of companies. Date: 20 May 2002 Media Enquiries: Emily Denney, Tel: +44 (0) 207 304 5034 Steve Brown, Tel: +44 (0) 207 304 5033 Investor Relations: Mina Blair Robinson, Tel: +44 (0) 207 304 5084 Jonathan Hunt, m Tel: +44 (0) 207 304 5087 -Ends- This information is provided by RNS The company news service from the London Stock Exchange

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