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Iressa Phase II study results show lung cancer promise

ORLANDO, FL -- Data confirming AstraZeneca's ZD1839 (Iressa) as an active and generally well-tolerated, potential new treatment approach for patients with previously treated advanced non-small-cell lung cancer were presented last weekend at the American Society of Clinical Oncology (ASCO) 38th Annual Meeting.

Results from the IDEAL 2 study, involving over 200 symptomatic patients treated with ZD1839, showed major reduction in tumor size in 12 percent of patients.

Forty-three percent of patients experienced an improvement in lung cancer disease symptoms and, of these, many showed an improvement by the second week of treatment. The new IDEAL 2 data add further weight to the very encouraging IDEAL 1 interim data first presented in November 2001.

Data being presented at ASCO also highlights the potential of ZD1839  in a broader range of solid common tumour types, including head and neck cancer.

Lead investigator of the IDEAL 2 study, Mark Kris, M.D., Chief of the Thoracic Oncology Service at Memorial Sloan-Kettering Cancer Center, New York, N.Y., said, "The tumor response rates and rapid symptom changes we are seeing with ZD1839 in this advanced disease population are important, especially when you consider that numerous other approaches have already failed in these patients."

Dr George Blackledge, Vice President, Medical Director of Oncology, AstraZeneca stated: "We have seen good antitumour activity in this population of lung cancer patients with advanced disease, even after numerous other therapeutic approaches have failed. We have also seen very sick patients benefit from rapid symptom relief and improved quality of life with ZD1839 (Iressa) throughout our clinical trial experience."

IDEAL 2, a randomized, double-blind, parallel-arm study, was designed to evaluate tumour response, disease-related symptom response and the safety profile of ZD1839 (Iressa) monotherapy.

All patients in the IDEAL 2 study had locally advanced or metastatic non-small-cell lung cancer (NSCLC), and all had received at least two prior chemotherapy regimens, including platinum-based therapy and docetaxel. One in four patients enrolled in IDEAL 2 had already been received with four or more chemotherapy treatments.

Specific findings:

  • Tumour response was reported in 11.8 per cent of patients treated with 250mg daily.
  • The duration of response ranged from three to over seven months with many patients still responding at the time of data cut-off; a further 31 per cent of patients treated with 250mg daily experienced disease stabilisation.
  • Symptom response was reported in 43 per cent of the patients treated with 250mg daily.
  • 60 per cent of patients who experienced a reduction in disease symptoms did so by the second week of treatment.
  • The median survival in patients treated with 250 mg was 6.5 months.

Results also provided further confirmation of ZD1839's (IRESSA) favourable safety profile, with the majority of side effects (diarrhea and skin rash) reported as mild and reversible. Prophylactic treatment for adverse events was not included in the study protocol.

Other ongoing Iressa studies include: Phase III studies in NSCLC (INTACT 1 and 2); Phase II head and neck studies; hormone refractory prostate cancer (HRPC); breast and colorectal cancers; and early investigative studies in other tumour types, and in combination with different treatment modalities. Studies of ZD1839 in earlier stages of NSCLC will be underway later this year.

Iressa is currently under regulatory review 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, respectively.

Iressa is potentially one of 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 ZD1839 is not causally associated with the same types of side effects such as alopecia, neutropenia or other hematological toxicity. It is administered as a once daily, oral tablet. ZD1839 targets and blocks, within the cell, signaling 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.

Posted: May 2002