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21 May 2002
ASTRAZENECA ANNOUNCES RESULTS FOR IRESSA ™ (ZD1839) IN ADVANCED HEAD AND NECK CANCER

AstraZeneca today announced data from the first Phase II trial of 'Iressa' in patients with recurrent, advanced squamous cell cancer of the head and neck, whose disease had progressed following radiation and/or chemotherapy, at the American Society of Clinical Oncology (ASCO) 38th Annual Meeting in Orlando, Florida.

Head and neck cancer is the sixth most frequently occurring cancer worldwide. The prognosis for patients with advanced, recurrent disease is poor, with less than 20 per cent of patients surviving at one year. The worldwide market for head and neck tumours is currently worth approximately $65 million, but is scheduled to grow to $243 million by 2008.

In this study, patients had an overall tumour response rate of 11 per cent. Disease control rate, including partial responses, complete responses, and stable disease, was reported as 53 per cent of the 47 patients assessed in the study. The median time to disease progression was 3.4 months. Median survival was also extended over the expected 6 months for this patient population to a reported 11 months with 47 per cent of the patients surviving at one year. The study was conducted by the University of Chicago and the National Cancer Institute (NCI) with 'Iressa' provided by AstraZeneca.

'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.

'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. Results from the Ideal 1 and 2 studies also presented at ASCO provided further confirmation of the safety profile for 'Iressa', with the majority of side effects (diarrhoea and skin rash) reported as mild and reversible. 'Iressa' 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.

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.

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