Iressa Study Results
AstraZeneca PLC
20 May 2002
Iressa(TM) Study Results Confirm Efficacy in Advanced Non-small
Cell Lung Cancer
AstraZeneca announced today that the final phase II results from the pivotal
'Iressa' IDEAL ('Iressa' Dose Evaluation in Advanced Lung Cancer) 1 and 2
studies presented at the American Society of Clinical Oncology (ASCO) 38th
Annual Meeting in Orlando, Florida, confirm 'Iressa' as an effective, potential
new treatment approach, with a favourable tolerability profile for many patients
with advanced non-small cell lung cancer (NSCLC). Additional data on 'Iressa'
in patients with recurrent, advanced squamous cell cancer of the head and neck,
whose disease has progressed following radiation and/or chemotherapy, will be
presented tomorrow (Tuesday, May 21 - announcement to appear on http://
www.astrazeneca.com/ mainnav1/s_news/c_news/ index.html).
Taken together, the results from IDEAL 1 and 2, in which more than 400 patients
with previously treated advanced NSCLC were treated with 'Iressa', demonstrate
consistent anti-tumour activity and potential patient benefits for 'Iressa'.
These well-controlled phase II trials were unprecedented in their scope and
design to test a novel, molecularly targeted anticancer agent, and AstraZeneca
is highly encouraged by the remarkable consistency of effect in these trials,
especially in IDEAL 2, where patients had previously failed on multiple cancer
treatments.
Lung cancer is a leading cause of cancer death for both men and women and the
incidence continues to increase world-wide. The five-year relative survival
rate for all stages of lung cancer combined is only 15 per cent. The worldwide
market for lung cancer is currently worth approximately $1.6 billion, the
majority of which is accounted for by NSCLC.
'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.
IDEAL Study Results
The IDEAL 2 study was a randomised, double-blind, parallel-arm study, designed
to evaluate tumour response, disease-related symptom response and the safety
profile of 'Iressa' monotherapy. Two hundred and sixteen patients were
randomised to receive oral 'Iressa' at either 250mg per day or 500mg per day.
All patients in the IDEAL 2 study had locally advanced and/or metastatic NSCLC,
and all had previously failed at least two, and as many as five, prior
chemotherapy regimens, including platinum-based therapy and docetaxel. One in
four patients enrolled in IDEAL 2 had already been treated with four or more
chemotherapy treatments, which had ceased to continue to provide benefit. Top
line results are as follows:
• Tumour response was reported in 11.8 per cent of patients treated
with 250mg daily
• Symptom response was reported in 43 per cent of all patients and in
95 per cent of patients with tumour response treated with 250mg daily
• Median survival of patients treated with 250 mg daily was 6.5 months
The IDEAL 1 study also tested the safety and efficacy of 250 mg and 500 mg of
'Iressa', but did so in patients who had previously failed on only one or two
cytotoxic regimens. In contrast to IDEAL 2, these patients were not required to
be symptomatic at baseline. Final results from the IDEAL 1 study were presented
at the ASCO meeting and the top line results are as follows:
• Tumour response rate was 18.4 per cent with 250 mg daily
• Thirty-four (34) per cent of patients remained progression free after
four months
• Symptom response was reported in 40 per cent of patients
Overall, there was comparable efficacy for both 250 mg/day and 500 mg/day
treatment; however, the 500 mg dose caused greater toxicity as measured by the
incidence of adverse events and withdrawals due to drug-related adverse events.
Additionally, results from IDEAL 1 and 2 provided further confirmation of the
favourable
safety profile for 'Iressa', with the majority of side effects (diarrhoea and
skin rash) reported as mild and reversible.
'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. It 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.
'Iressa' is a trademark of the AstraZeneca group of companies.
Date: 20 May 2002
Media Enquiries:
Emily Denney, Tel: +44 (0) 207 304 5034
Steve Brown, Tel: +44 (0) 207 304 5033
Investor Relations:
Mina Blair Robinson, Tel: +44 (0) 207 304 5084
Jonathan Hunt, m Tel: +44 (0) 207 304 5087
-Ends-
This information is provided by RNS
The company news service from the London Stock Exchange