WILMINGTON, Del., Nov. 30 /PRNewswire-FirstCall/ -- AstraZeneca (NYSE: AZN) announced today that it has completed enrollment of patients in the ZEST (ZACTIMA Efficacy Study versus Tarceva) study, the first of four Phase III trials for the investigational once-daily oral anti-cancer drug vandetanib. Data from the study is expected in 2008.
ZEST is a randomized, double-blind, multi-center Phase III study to assess the efficacy of vandetanib versus erlotinib in overall survival (OS) and progression-free survival (PFS) in over 1,150 patients with locally-advanced or metastatic non-small cell lung cancer (NSCLC) after failure of first-line anti-cancer therapy.
"Non-small cell lung cancer is an area of high unmet medical need, and we hope vandetanib will offer a beneficial new treatment option for people with lung cancer," said Dr. Peter Langmuir, Medical Science Director at AstraZeneca.
ZEST is part of a Phase III clinical trial program to gain a broad
understanding of how vandetanib may benefit people with lung cancer.
The other studies are:
-- ZODIAC (vandetanib + docetaxel versus docetaxel alone)
-- ZEAL (vandetanib + pemetrexed versus placebo + pemetrexed); and,
-- ZEPHYR (vandetanib + best supportive care (BSC) versus placebo + BSC).
These studies are currently recruiting patients.
The Phase III program in NSCLC follows results from two Phase II trials where vandetanib was studied either alone or in combination with standard chemotherapy (docetaxel). (1)(2) Vandetanib is also being evaluated as a treatment option in medullary thyroid cancer and has been awarded Food and Drug Administration (FDA) orphan drug status and fast track designation for this indication.
AstraZeneca is a major international health care business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of health care services. It is one of the world's leading pharmaceutical companies with health care sales of $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 FTSE4Good Index.
In the United States, AstraZeneca is a $12.44 billion health care business with more than 12,000 employees. For nearly three decades, AstraZeneca has offered drug assistance programs side by side with its medicines, and over the past five years, has provided over three billion in savings to more than one million patients throughout the U.S. and Puerto Rico. AstraZeneca has been named one of the "100 Best Companies for Working Mothers" by Working Mother magazine and is the only large pharmaceutical company named to FORTUNE magazine's 2007 list of "100 Best Companies to Work For." In 2006, for the fifth consecutive year, Science magazine named AstraZeneca a "Top Employer" on its ranking of the world's most respected biopharmaceutical employers.
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ZACTIMA is a registered trademark of the AstraZeneca group of companies.
(1) Natale RB et al. ZD6474 versus gefitinib in patients with advanced
NSCLC: Final results from two-part, double-blind randomized phase II
trial. Journal of Clinical Oncology, Vol 24, No 18S, 2006: 7000.
(2) Heymach JV et al. Randomized, Placebo-Controlled Phase II Study of
Vandetanib Plus Docetaxel in Previously Treated Non-Small-Cell Lung
Cancer Journal of Clinical Oncology, Vol 25, No 27, 2007: 4270-4277.
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