New Survival Study of Vandetanib (ZACTIMA(TM), ZD6474) in Patients With Advanced Lung Cancer

ALDERLEY PARK, England, November 16 /PRNewswire/ --

- First Patient Enrolled in Phase III International Randomised, Double-Blind, Placebo-Controlled Study of Vandetanib for Non-Small Cell Lung Cancer (NSCLC) After Failure of EGFR TKI Therapy

AstraZeneca today announced the start of enrolment into a new Phase III study of the novel once-daily oral anti-cancer drug vandetanib (ZACTIMA(TM), ZD6474) as third/fourth line treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have progressed following EGFR TKI therapy. The study - Study 44 - will be conducted at 208 centres across 23 countries worldwide, and is expected to enrol over 930 patients.

Study 44 will evaluate overall survival with vandetanib 300mg plus best supportive care (BSC) compared with placebo plus BSC in patients with advanced NSCLC, who have previously received treatment with chemotherapy and an epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI). The study will also assess progression free survival, objective response rate, disease control rate, duration of response, effect on disease related symptoms, and safety and tolerability of vandetanib.

Study 44 Principal Investigator Dr. Jin Soo Lee, National Cancer Centre, Gyeonggi, Korea, commented, "There are currently very limited treatment options available for patients after their cancer has progressed on second line treatment. Phase II studies have demonstrated promising anti-tumour efficacy with vandetanib in lung cancer, and Study 44 will now investigate if this multi-targeted agent can improve outcomes for patients."

Study 44 forms part of an extensive ongoing clinical development programme of vandetanib in NSCLC and is the third Phase III study for vandetanib in NSCLC to have begun patient enrolment this year. Other studies include:

- Study 57 - an international randomised, double-blind, study of vandetanib 300mg monotherapy versus erlotinib 150mg in patients with advanced NSCLC after failure of at least one but no more that two, prior chemotherapy regimens.

- Study 32 - an international randomised, double-blind study, comparing docetaxel alone versus treatment with vandetanib 100mg in combination with docetaxel in patients with locally advanced or metastatic NSCLC after failure of first-line treatment.

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.[3],[4] Vandetanib has also shown encouraging early data in hereditary medullary thyroid cancer[5] 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.[1]

- 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%.[2]

- 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 $23.95 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 FTSE4Good Index.

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

References

[1]. Ferlay J, Bray F, Pisani P, et al. GLOBOCAN 2002: Cancer Incidence, Mortality and Prevalence Worldwide IARC CancerBase No. 5. version 2.0, IARCPress, Lyon, 2004.

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

[3]. Natale R et al. A comparison of the antitumour efficacy of ZD6474 and gefitinib (Iressa(TM)) in patients with NSCLC: results of a randomized, double-blind Phase II study. Lung Cancer 2005; 49 (Suppl 2): S36.

[4]. Herbst R et al. ZD6474 plus docetaxel in patients with previously treated NSCLC: results of a randomized, placebo-controlled phase II trial. Lung Cancer 2005; 49 (Suppl 2): S35.

[5]. Wells S et al. The Use of ZACTIMA(TM) (ZD6474) in the Treatment of Patients with Hereditary Medullary Thyroid Carcinoma. Presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, November 2005.