The INTEREST (IRESSA Non–small-cell lung cancer Trial Evaluating REsponse and Survival against Taxotere) trial will evaluate the effectiveness of the oral anti-cancer agent, IRESSA® (gefitinib) Tablets versus Taxotere® (docetaxel) in patients with locally advanced or metastatic nonsmall-cell lung cancer (NSCLC) who have previously received platinum-based chemotherapy. This trial is the first time IRESSA is being compared to chemotherapy in this patient population. IRESSA is currently approved by the Food and Drug Administration (FDA) for NSCLC patients who have progressed on or been unable to tolerate two types of chemotherapy.

The primary objective of the study is to compare the overall survival of patients taking IRESSA to those taking the chemotherapy Taxotere. This trial will also compare the safety, tolerability and effects on patients with IRESSA and Taxotere chemotherapy use. The results of this trial may ultimately help to determine whether IRESSA can be used as a substitute for chemotherapy.

“This is a starting point to test whether biologic therapy can be as good as chemotherapy. It is a head-to-head comparison, so we will know if survival numbers are equivalent,” said Dr. Edward Kim, M.D. Anderson Cancer Center. “We’ll also know if the side-effect profiles are any different as well as the toxicities.”

Lung cancer is the leading cause of cancer deaths in the United States, estimated to account for approximately 160,440 deaths in 2004. NSCLC is the most common form of lung cancer, accounting for 80 percent of all lung cancer cases.1

Physicians and patients can obtain additional information about IRESSA and clinical trials by calling the AstraZeneca Cancer Support Network at 1-866-99-AZCSN (1-866-992-9276).

About IRESSA

The FDA approved IRESSA in May 2003 based upon data from a US Phase II trial that studied two doses of IRESSA in a total of 216 patients who received both platinum-based and docetaxel chemotherapies. Included in the FDA analysis were 142 of the 216 patients. In the group receiving the recommended dose of 250 mg/day, 13.6% (95% CI: 6.4-24.3) of the patients had their tumor shrink by at least 50%. Higher doses did not give a better response and more side effects were observed. The overall response rate for both doses combined in all 142 patients was 10.6% (95% CI: 6.0-16.8). Median duration of response was 7 months (range 4.4 to 18.6+ months). The response rates appeared to be highly variable in subgroups of the treated population (gender, smoking history and histology) varying from 4.6-29.4%.

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 and 2) showed no benefit from adding IRESSA to a doublet, platinum-based chemotherapy. Therefore, IRESSA is not indicated for use in this setting.

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.

About AstraZeneca

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.