Download Colorectal Cancer

news release
June 2, 2003
IRESSA™ (gefitinib) DEMONSTRATES CLINICAL ACTIVITY
IN MULTIPLE TUMOUR TYPES
AstraZeneca announced today that new data presented at the 39th American
Society of Clinical Oncology Annual Meeting in Chicago demonstrate the potential of
IRESSA (gefitinib, ZD1839) to have anti-tumour activity across a broad range of
common cancers. Encouraging data from Phase ll trials in advanced colorectal
cancer, non-small cell lung cancer (NSCLC), breast cancer and brain cancer
support IRESSA’s current and future role as an efficacious anti-cancer agent that is
generally well tolerated across all tumour types.
“Data demonstrating IRESSA’s clinical efficacy in advanced NSCLC have now led to
approvals in several major markets, “said Brent Vose, Vice President, Oncology
Therapy Area. “Today’s news that there is further evidence to suggest IRESSA may
also provide clinical benefit in additional cancers is encouraging, and we are
committed to researching and further developing IRESSA in a number of these
disease areas through an extensive clinical trial programme.”
IRESSA is the first in a new class of anti-cancer drugs known as Epidermal
Growth Factor Receptor (EGFR) – Tyrosine Kinase (EGFR-TK) inhibitors and
has been approved for the treatment of advanced NSCLC by the U. S. Food and
Drug Administration, the Australian Therapeutic Goods Administration, and the
Japanese Ministry of Health, Labour and Welfare. IRESSA is currently
undergoing regulatory review with several other regulatory authorities worldwide
for the treatment of advanced NSCLC.
Since its launch in Japan in July 2002, IRESSA has recorded $86 million in sales.
The worldwide market for lung cancer is currently worth approximately $1.6
billion, the majority of which is accounted for by NSCLC, and is expected to grow
to $8 billion by 2011. Advanced colorectal cancer and breast cancer each
represent additional multi-billion dollar potential markets.
COLORECTAL CANCER
Encouraging early phase II data indicate that the addition of IRESSA to the triple
combination chemotherapy known as FOLFOX* for advanced colorectal cancer
could lead to improvements in clinical outcomes. Data demonstrated that 75 per
cent of previously untreated colorectal cancer patients achieved a partial response
―where their tumour had shrunk by at least half ― when they received IRESSA in
combination with FOLFOX. Additionally, 29 per cent of patients whose cancer
progressed on prior chemotherapy responded when given FOLFOX plus IRESSA.
AstraZeneca
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Reg Office AstraZeneca AB (publ)
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Reg No 556011-7482
VAT No SE556011748201
news release
June 2, 2003
Previous studies have shown that FOLFOX alone gives an overall response rate of
approximately 50 per cent in previously untreated patients, while for patients who
have received prior therapy; the response rate is around 9 per cent. The data also
showed the combination with IRESSA to be generally well tolerated, with the most
commonly reported side effects being diarrhoea and nausea. Colorectal cancer is
the second most common cancer in the world.
Non Small Cell Lung Cancer (NSCLC)
New findings from the IDEAL** 2 study demonstrate that patients, with advanced
NSCLC cancer who had failed at least two prior treatments, experienced
improvement in the debilitating symptoms of their cancer when taking IRESSA
monotherapy once daily, and were more likely to achieve better outcomes in terms
of their overall survival rates and tumour shrinkage if their symptoms improved.
A separate retrospective analysis of NSCLC patients who received IRESSA once
daily on a compassionate use basis, also reveals that those who had failed at least
one previous chemotherapy treatment achieved good disease control. Out of 72
evaluable patients, 43 per cent achieved disease control, where their cancer had
stopped progressing or they experienced tumour shrinkage. IRESSA also
demonstrated an acceptable safety profile with the most frequent side effects
observed being skin rash and diarrhoea.
BREAST CANCER
Two Phase ll trials in patients with advanced breast cancer who had failed previous
treatment options confirm previously reported clinical activity of monotherapy
IRESSA in recurrent breast cancer. The first study assessed anti-tumour activity
and tolerability of IRESSA in 31 patients with advanced breast cancer. Ten patients
(32 per cent) experienced stable disease (SD) for at least three months, including
six patients who had SD for more than 4 months and three patients for more than 6
months. IRESSA was generally well tolerated with the majority of adverse events
being mild (grade 1/2).
In a second study of 33 patients with advanced breast cancer, IRESSA was also
generally well tolerated and had anti-tumour activity in patients with ER-negative
tumours and ER-positive tumours, who had been treated with tamoxifen but had
developed resistance to the drug.
BRAIN CANCER
Two studies further suggest IRESSA may have anti-tumour activity in several types
of brain cancers, including glioblastoma multiforme (GBM), one of the most common
but aggressive and fatal forms of primary brain tumours. In the first study, 51
patients ― diagnosed with glioblastomas and who had received previous treatment
― were treated with IRESSA. Of these, one patient achieved a partial response
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news release
June 2, 2003
and 22 (43 per cent) achieved stable disease where their cancer stopped
progressing. In a second study, of 50 patients, five patients achieved a partial
response (four patients had glioblastoma and one patient had anaplastic
oligodendroglioma), when treated with IRESSA after their tumours had progressed
following radiation therapy. IRESSA’s tolerability profile was consistent with that
seen in other trials with the most common side effects being skin rash, fatigue and
diarrhoea.
Media Enquiries:
Staffan Ternby, 08-553 261 07, 070/557 43 00
Emily Denney, +44 (0) 207 304 5034
Louise Marland, Global PR Manager, Oncology, +44 (0) 7900 607794
Investor Relations:
Staffan Ternby, 08-553 261 07, 070/557 43 00
Mina Blair Robinson, +44 (0) 207 304 5084
Jonathan Hunt, +44 (0) 207 304 5087
Notes to editors
IRESSA™ is a trademark of the AstraZeneca group of companies.
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For further information on the Epidermal Growth Factor Receptor and its
potential role in cancer treatment, please visit www.EGFR-INFO.com
For further information on IRESSA™ and lung cancer, please visit
www.iressa.com
For further press information regarding IRESSA™ and other AstraZeneca
cancer therapies, please visit www.cancerpressoffice.com
* FOLFOX is a triple combination of oxaliplatin and 5-fluorouracil (5-FU) two
cytotoxic chemotherapy agents with leucovorin (folinic acid)
** IDEAL = IRESSA Dose Evaluation in Advanced Lung Cancer
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