Fourth Phase III Study of Vandetanib (ZACTIMA(TM), ZD6474) in Patients With Advanced Lung Cancer

Alderley Park, England (ots/PRNewswire) -

- A Phase III international, parallel group, randomised,
double-blind study of vandetanib in combination with pemetrexed for
advanced non-small cell lung cancer (NSCLC) after failure of first
line anti-cancer therapy

AstraZeneca today announced that a new Phase III study of novel
once-daily oral anti-cancer drug, vandetanib (ZACTIMA(TM), ZD6474),
is underway. The study - Study 36 - will investigate the addition of
vandetanib to pemetrexed (Alimta(R)) as second line treatment for
patients with locally advanced or metastatic non-small cell lung
cancer (NSCLC) after failure of first line anti-cancer treatment.
Study 36 will be conducted across 20 countries worldwide, and is
expected to enrol at least 508 patients.

As its primary objective, Study 36 will evaluate progression-free
survival with vandetanib 100mg plus pemetrexed 500mg/m2 compared with
pemetrexed 500mg/m2 plus placebo in patients with advanced NSCLC, who
have previously received anti-cancer treatment. The study will also
assess overall survival, objective response rate, disease control
rate, duration of response, effect on disease related symptoms, time
to deterioration of disease-related symptoms, the safety and
tolerability of vandetanib in combination with pemetrexed, and
population pharmacokinetics of vandetanib

Study 36's Principal Investigator, Dr. Richard de Boer, Western
Hospital, Victoria, Australia, commented "After treatment failure
with initial therapy, response rates to further treatment is low in
patients with advanced non-small cell lung cancer. The effect of
combining novel targeted agents such as vandetanib with chemotherapy
needs to be explored to progress treatment options for patient
benefit."

Study 36 forms part of an extensive ongoing clinical development
programme for vandetanib in NSCLC and is the fourth Phase III study
in this tumour; the other three studies are:

Vandetanib (ZACTIMA(TM), ZD6474)

Vandetanib works by inhibiting both the development of the
tumour's blood supply through inhibition of VEGFR (anti-angiogenesis)
and the growth and survival of the tumour itself through inhibition
of EGFR. It also inhibits RET kinase, an important growth factor in
certain types of thyroid cancer. Vandetanib has shown promising
anti-tumour activity in NSCLC when used alone and in combination with
docetaxel in Phase II trials.1,2 It has also shown encouraging early
data in hereditary medullary thyroid cancer3 and has been awarded FDA
and EU orphan drug status, and FDA fast track designation for this
indication. Vandetanib is currently in clinical development in a
range of tumours.

ZACTIMA(TM) is a trademark of the AstraZeneca group of companies.

Notes to editors

- Over 1.35 million new cases of lung cancer are diagnosed every
year and nearly 1.2 million people die as a result of this
devastating disease - more than breast, colon and prostate cancer
combined.4

- If lung cancer is detected at early stages, before it has spread
to other organs or lymph nodes, around half of patients can survive
for five years or more. However, few lung cancers are found at this
early stage and it is normally diagnosed at the advanced stage, when
five year survival falls to approximately 15%.5

- 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 US$26.47 billion and leading positions in sales
of gastrointestinal, cardiovascular, neuroscience, respiratory,
oncology and infection products. AstraZeneca is listed in the Dow
Jones Sustainability Index (Global) as well as the FTSE4 Good Index.

- For more information about AstraZeneca, please visit:
www.astrazeneca.com

References

1. Natale RB et al. ZD6474 versus gefitinib in patients with
advanced NSCLC: Final results from a two-part, double-blind
randomized phase II trial. Proceedings of ASCO 2006; abstract no.
7000.

2. Heymach JV et al. A phase II trial of ZD6474 plus docetaxel in
patients with previously treated NSCLC: Follow-up results.
Proceedings of ASCO 2006; abstract no. 7016.

3. Wells S et al. A phase II trial of ZD6474 in patients with
hereditary metastatic medullary thyroid cancer. Proceedings of ASCO;
abstract no. 5533.

4. Ferlay J et al. GLOBOCAN 2002: Cancer Incidence, Mortality and
Prevalence Worldwide IARC CancerBase No. 5. version 2.0, IARCPress,
Lyon, 2004.

5. Bepler G. Lung cancer epidemiology and genetics. Journal of
Thoracic Imaging 1999;14(4):228-34.

ots Originaltext: AstraZeneca
Im Internet recherchierbar: http://www.presseportal.de

Contact:
For further information, please contact: Janet Milton-Edwards,
AstraZeneca, Tel: +44-(0)-1625-515-275, Mobile: +44-(0)-7990-640-119,
janet.milton-edwards@astrazeneca.com, Carrie Deverell, AstraZeneca,
Tel: +44-(0)-1625-514-77, Mobile: +44-(0)-7929-845-108,
carrie.deverell@astrazeneca.com


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