Final publication of the groundbreaking results with novel treatment gefitinib (IRESSA, ZD1839) in lung cancer patients

London 15 June, 2003 – AstraZeneca’s new anti-cancer drug gefitinib (IRESSA, ZD1839) has shown unprecedented clinical benefit in the treatment of advanced non-small cell lung cancer (NSCLC), according to key study results published today in the Journal of Clinical Oncology. In the international IDEAL 1 study (IRESSA Dose Evaluation in Advanced Lung Cancer), over 50% of advanced NSCLC patients – whose tumours had progressed on previous, conventional chemotherapy – showed stabilisation or regression of their disease with gefitinib 250mg/day, accompanied in the majority of cases by rapid improvement in the debilitating symptoms of lung cancer (which include unrelenting cough, chest pain, shortness of breath and fatigue).

‘These were very seriously ill patients for whom established cancer treatments could offer nothing more’ explained lead investigator Professor Giuseppe Giaccone of Academic Hospital Free University, Amsterdam, The Netherlands. ‘Not only did gefitinib hold back the progression of the disease in half the patients but in nearly 20% of patients their tumours actually shrunk, something we would not normally expect to see at this sort of stage in the illness.’Gefitinib – the first in a new class of biological anti-cancer drugs known as ‘Epidermal Growth Factor Receptor (EGFR) inhibitors’ – is thought to work by blocking a specific set of chemical signals that tell cancer cells to grow and multiply. It has been approved for the treatment of advanced non-small cell lung cancer (NSCLC) in the United States, Australia and Japan and is currently undergoing regulatory review with several other regulatory authorities worldwide for the treatment of advanced NSCLC. Unlike standard cytotoxic drugs, gefitinib does not cause haematological side effects and the majority of side effects reported (for example diarrhoea and skin rash) are mild and reversible.’Although sadly the majority of patients with advanced lung cancer have a limited life expectancy and few remaining treatment options, gefitinib has provided benefits never before observed in this very sick population – a few extra weeks or months of life with rapid and noticeable relief from symptoms after an average of eight days,’ Professor Giaccone said.Brent Vose, Vice President and Head of Oncology at AstraZeneca commented, ‘Lung cancer is a complex, severely symptomatic illness with a devastating impact on the patient and their family. Survival rates are often very poor and over the past three decades there have been few advances in treatment options or survival outcomes for patients with advanced lung cancer. New treatment options like gefitinib, which can help stabilise the disease and improve quality of life, are urgently needed.’Lung cancer is the biggest cancer killer in the world, causing more deaths each year than breast, prostate and bowel cancer put together. NSCLC is the most common form, accounting for 80% of cases. In the year 2000 there were over 1.2 million people diagnosed with lung cancer world-wide (approximately 370,000 in Europe) and more than 1 million people died from the disease (340,000 in Europe). Only 1 in every 10 people with lung cancer is alive 5 years after diagnosis. In contrast, with recent advances in treatment and care, almost three quarters of women with breast cancer can expect to live for at least five years and often much longer.AstraZeneca continues its tradition of research excellence and innovation in oncology that led to the development of its current anti-cancer therapies including ‘Arimidex’, ‘Casodex’, ‘Faslodex’, ‘Nolvadex’, ‘Zoladex’ and ‘Tomudex’ as well as a range of novel targeted products such as anti-proliferatives, anti-angiogenics, vascular targeting and anti-invasive agents. AstraZeneca is also harnessing rational drug design technologies to develop new compounds that offer advantages over current cytotoxic and hormonal treatment options. The company has over 20 different anti-cancer projects in research and development.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 $17.8 billion and leading positions in sales of gastrointestinal, oncology, cardiovascular, neuroscience and respiratory products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global and European) as well as the FTSE4Good Index.For more information, please visit www.astrazenecapressoffice.com