28.09.2006 – 10:02
PHASE III Study Compares Vandetanib (Zactima(TM), ZD6474) to Erlotinib in Advanced Lung Cancer
- First Patient Enrolled in Pivotal International Randomised, Double-Blind Study of Vandetanib Versus Erlotinib
FOR NON-US HEALTHCARE PROFESSIONAL PRESS ONLY
AstraZeneca (NYSE:AZN) 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), comparing it with erlotinib in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). The study, known as Study 57, will be conducted at approximately 160 centres across 23 countries, and is expected to enrol over 1,150 patients. It marks the first Phase III direct comparison of vandetanib with erlotinib, and forms part of an extensive clinical development programme of vandetanib in NSCLC.
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) Study 57 will evaluate progression free survival with oral vandetanib 300mg compared with oral erlotinib 150mg in patients with advanced NSCLC after failure of at least one but no more than two prior chemotherapy regimens. The study will also compare vandetanib and erlotinib for overall survival, objective response rate, disease control rate, response duration, effect on disease related symptoms, quality of life assessments, and safety and tolerability.
Medical Science Director for ZACTIMA at AstraZeneca, Peter Langmuir, commented, "Research in lung cancer has helped us identify specific pathways that play an important role in the development and progression of this disease. Treatments are in development that reflect these research advances, and investigation is needed to assess anti-tumour activity with new agents which target multiple key pathways, such as vandetanib, compared to currently available single-target treatments."
Study 57 is the second Phase III study for vandetanib in NSCLC to have begun patient enrolment this year. Study 32, announced in June 2006, is an international randomised, double-blind, placebo controlled study, comparing treatment with vandetanib 100mg plus docetaxel versus docetaxel alone 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.(2,3) Vandetanib has also shown encouraging early data in hereditary medullary thyroid cancer(4) 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
- Lung cancer is a leading cause of cancer death for both men and women worldwide and the incidence is increasing.(1) Prognosis for lung cancer is generally poor. 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$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
For further information, please contact:
Janet Milton-Edwards Carrie Deverell
Tel: +44-(0)-1625-515-275 Tel: +44-(0)-1625-514-77
Mobile: +44-(0)-7990-640-119 Mobile: +44-(0)-7929-845-108
ALDERLEY PARK, England, September 28 /PRNewswire/ --
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. 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.
3. 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.
4. 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.
5. Bepler G. Lung cancer epidemiology and genetics. Journal of Thoracic Imaging 1999;14(4):228-34.
ots Originaltext: AstraZeneca
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