New IRESSA(R) (Gefitinib) Data Presented in Bronchioalveolar Lung Cancer Data from the largest study ever conducted of patients with bronchioalveolar cancer reported NEW ORLEANS, June 5 /PRNewswire-FirstCall/ -- Data from the largest study ever conducted of patients with bronchioalveolar cancer (BAC) was presented today at the American Society of Clinical Oncology (ASCO) 40th Annual Meeting. Patients in this study received the oral medication IRESSA (gefitinib). BAC is a type of non-small-cell lung cancer (NSCLC) that has distinctive clinical, pathologic and radiographic characteristics. (Photo: http://www.newscom.com/cgi-bin/prnh/20030505/PHM039 ) "These results represent an important step forward in our efforts to better understand the complexities of this unique subset of non-small-cell lung cancer," said Dr. Howard West, lead investigator for the trial. The study was conducted by the Southwestern Oncology Group (SWOG) and enrolled 138 patients (102 chemo-na�ve, 36 previously treated) who received 500 mg of IRESSA once daily until disease progression or drug-related toxicity. Among 69 chemo-naive patients with measurable disease, the response rate (RR) was 19%, with 6% of patients experiencing a complete response (CR). In 22 previously treated patients with measurable disease, RR was 9% (0% CR). One-year survival was reported as approximately 50% in each group. Adverse events in the BAC trial included acneiform rash, diarrhea and pulmonary toxicity. Lung cancer is the leading cause of cancer deaths in the United States, estimated to account for more than 160,000 deaths in 2004.(1) NSCLC is the most common form of lung cancer, accounting for 80 percent of all lung cancer cases. BAC is increasing in incidence, especially in younger non-smoking women. About IRESSA IRESSA is approved in the United States for use as monotherapy for the treatment of patients with locally advanced or metastatic NSCLC after failure of both platinum-based and docetaxel chemotherapies. The effectiveness of IRESSA is based on objective response rates. There are no controlled trials demonstrating a clinical benefit, such as improvement in disease-related symptoms or increased survival. Results from two large (N = 2,130), controlled, randomized trials in first-line treatment of NSCLC (INTACT 1 & 2) showed no benefit from adding IRESSA to a doublet, platinum-based chemotherapy. Therefore, IRESSA is not indicated for use in this setting. The recommended dose of IRESSA in advanced NSCLC patients who have received platinum and docetaxel is 250 mg daily. Higher doses did not produce increased efficacy and resulted in increased toxicity. The response rates in the IDEAL 2 study were 13.6% (95% CI: 6.4-24.3%) at the recommended dose of 250 mg and 10.6% (95% CI: 6.0 - 16.8%) for the 250 mg and 500 mg groups combined. In a retrospective analysis, the response rates appeared to be highly variable in sub-groups of the treated population (gender, smoking history, and histology), varying from 4.6% to 29.4%. The most frequent drug-related adverse events associated with IRESSA were diarrhea (48%) sometimes associated with dehydration, rash (43%), acne (25%), dry skin (13%), nausea (13%), and vomiting (12%). These events generally occurred within the first month of therapy and usually were mild to moderate. Two percent of patients stopped taking IRESSA due to an adverse drug reaction. Infrequent cases (about 1%) of interstitial lung disease (ILD-described as interstitial pneumonia, pneumonitis, and alveolitis) have been observed in patients receiving IRESSA. Approximately 1/3 of the ILD cases were fatal. When ILD occurred, it was often accompanied by acute onset of breathing difficulty with cough or low-grade fever requiring hospitalization. The reported incidences of ILD in the 23,000 patient US expanded access program was about 0.3%. In Japanese postmarketing experience the reported rate of ILD was about 2%. In the phase III controlled studies in combination with chemotherapy, there were similar rates of ILD (about 1%) reported in both the placebo and IRESSA arms of the study. IRESSA may cause fetal harm if administered to a pregnant woman. Asymptomatic increases in liver enzymes and eye irritation have also been observed in patients receiving IRESSA. Increases in bleeding events have been observed in cancer patients taking warfarin and IRESSA. 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. In the United States, AstraZeneca is an $8.7 billion healthcare business with more than 11,000 employees. AstraZeneca is listed in the Dow Jones Sustainability Index (Global and European) as well as the FTSE4Good Index. For more information about AstraZeneca, please visit: http://www.astrazeneca-.com/ (1) American Cancer Society "Cancer Facts & Figures 2004" - 2004; 13 IRESSA is a registered trademark of the AstraZeneca group of companies. http://www.newscom.com/cgi-bin/prnh/20030505/PHM039 http://photoarchive.ap.org/ DATASOURCE: AstraZeneca CONTACT: Mary Lynn Carver, AstraZeneca, +1-302-886-7859, Web site: http://www.astrazeneca-us.com/ Company News On-Call: http://www.prnewswire.com/comp/985887.html

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