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As compared to Iressa trials. If you barf the drug up or crap it out it diminishes efficacy, I would imagine.





Data announced today at the 12th AACR-NCI-EORTC International Conference on
'Molecular Targets and Cancer Therapeutics', Miami, USA

Wilmington, DE—November 1, 2001 — Preliminary data from the first Phase II trial of
ZD1839 (IRESSA®) presented today reported a combined total of objective responses or
disease stabilization in more than 50% of patients who had advanced non-small cell lung
cancer (NSCLC) which had progressed following other treatments. ZD1839 is a once-daily,
orally administered, selective EGFR-TKI (epidermal growth factor receptor-tyrosine kinase
inhibitor).

ZD1839 is a small molecule that blocks tyrosine kinase (TK) activity on the epidermal growth
factor receptor (EGFR) within the cell. EGFR-TK is an enzyme that regulates intracellular
signaling pathways implicated in cancer cell proliferation and survival. Receptors for EGF and
related growth factors play a major role in the biology of cancer cells in many solid tumors.
ZD1839 is being evaluated as a treatment in a broad range of common types of cancer.

Jose Baselga, M.D., one of the lead investigators in the study from Vall d'Hebron University
Hospital, Barcelona, Spain, said today, "Lung cancer kills more people each year than
prostate and breast cancer put together, yet treatment options for this devastating disease are
still limited. Research on new treatment approaches like ZD1839 are badly needed. Non-small
cell lung cancer is a challenging disease and studies of this approach represent a significant
step forward."

In the international non-small cell lung cancer trial presented today, 210 patients were studied
in a randomized, double-blind study which evaluated two dosages of oral ZD1839 (250mg/day
and 500mg/day) taken as monotherapy. Patients included in the study had previously
progressed on one or two cytotoxic (chemotherapy) regimens, at least one of which contained
platinum, and had no further standard treatment options available to them. The primary
objectives of this study were to evaluate the objective tumor response rate and characterize
the safety profile of the two ZD1839 doses tested. Important secondary objectives included
assessment of disease-related symptom relief and disease control rate.

During the study, tumors were assessed every four weeks for the first four months and then
every eight weeks thereafter until disease progression. Study results presented today include
preliminary results in 208 patients after a minimum of four months follow-up. The overall tumor
response rate was 18.7% (39 patients out of 208). A secondary end point, overall disease
control rate, was 52.9% (tumor responses + disease stabilization was seen in 110 out of 208
patients). 34% (71 out of 208) of patients in the study remained progression free after four
months. All of the efficacy results were similar between the 250 and 500mg/day doses.

An important secondary end point included prospectively in this trial was estimated time to
disease related symptom relief including patient reported ease of breathing and less coughing
and chest tightness. The overall disease related symptomatic improvement rate was 38.7%
with a median time to improvement of eight days.

In this study, the most frequently occurring drug-related adverse events were mild skin
reactions and diarrhea. The drug related adverse events with ZD1839 were dose dependent
with fewer events and less severity at the 250mg/day dose. For the 250mg/day dose the
incidence for rash and diarrhea was 47% and 40%, respectively; for the 500mg/day dose the
incidence for rash and diarrhea was 69% and 58%, respectively. In most cases these events
did not require specific therapeutic intervention. Serious adverse events were uncommon and
usually related to disease progression. 9.4% of patients on 500mg/day withdrew due to drug
related adverse events compared with only 1.9% of those on 250mg/day.

A second similar Phase II study (IDEAL II) is near completion in the United States evaluating
ZD1839 as a monotherapy in NSCLC patients who had received at least two prior
chemotherapy regimens and who experienced disease progression or unacceptable toxicity
from their most recent therapy. In addition, two large studies evaluating ZD1839 given as a
first-line treatment for NSCLC in combination with commonly used types of chemotherapy are
fully recruited with results expected next year.

Additional data presented this week at the AACR-NCI-EORTC meeting highlighted the
ongoing evaluation of ZD1839 in a range of tumor types:

A Phase I study assessing the tolerability, efficacy and pharmacokinetics of ZD1839 in
combination with gemcitabine and cisplatin in patients with a variety of primary tumors.
A Phase I study evaluating ZD1839 in combination with fluorouracil and leucovorin in
patients with advanced colorectal cancer.
Pre-clinical data on the effects of ZD1839 in combination with tamoxifen (Nolvadex®) in
breast cancer cell lines.
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