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Newly Published Phase II Study Shows the Investigational Drug Vandetanib Prolongs Progression-Free Survival in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC)
Date:9/21/2007

- Phase III trials now underway to evaluate vandetanib as second-line NSCLC

treatment in combination with docetaxel -

WILMINGTON, Del., Sept. 20 /PRNewswire/ -- Results published today in the Journal of Clinical Oncology(1) show that the AstraZeneca investigational once-daily oral anti-cancer drug vandetanib (ZACTIMA), in combination with docetaxel, improved progression free survival (PFS) in patients with advanced Non-Small Cell Lung Cancer (NSCLC).

The Phase II trial - Study 6 - compared the combination of vandetanib 100mg or 300mg plus docetaxel to standard docetaxel alone. The trial demonstrated that adding vandetanib to standard docetaxel therapy prolonged median PFS to 18.7 weeks and 17 weeks respectively, compared to 12 weeks with docetaxel alone.(2)

"Given the poor prognosis in advanced non-small cell lung cancer, an increase in time to disease progression can be meaningful to patients," said Study 6 lead author John Heymach, Assistant Professor of Thoracic Head/Neck Medical Oncology at the University of Texas MD Anderson Cancer Centre . "The results of Study 6 provide encouraging support, and reinforce further investigation with ZACTIMA in combination with chemotherapy in Phase III trials."

Based on these data, AstraZeneca has initiated a Phase III trial, currently underway, to evaluate vandetanib and docetaxel in second-line treatment of non-small cell lung cancer. The ZODIAC (ZACTIMA in cOmbination with Docetaxel In non-smAll cell lung Cancer), trial is a randomised, double- blind study evaluating vandetanib 100mg in combination with docetaxel vs. docetaxel alone, in patients with locally advanced or metastatic NSCLC after failure of first-line treatment.

The study is recruiting and aims to enroll approximately 1400 patients worldwide at over 250 centers throughout Europe, North America, South America and Asia Pacific. The primary end points of the study are to assess PFS. Response rates and overall Survival (OS) will be evaluated as secondary endpoints in the study.

AstraZeneca is currently investigating vandetanib through an extensive NSCLC clinical trial program.

About Study 6

This randomized, double-blind, placebo -controlled Phase II trial evaluated the activity of vandetanib 100mg and 300mg in combination with standard docetaxel therapy (75 mg/m2 via intravenous infusion every 21 days) in 127 patients with advanced (stage IIIb/IV) NSCLC, including squamous cell carcinoma, after failure of first-line platinum-based chemotherapy.

Patients were randomized to vandetanib 100 mg + docetaxel (n=42), vandetanib 300 mg + docetaxel (n=44), or Docetaxel alone (n=41). The prolonged median progression-free survival (PFS) was 18.7 weeks (HR=0.64, 95% CI 0.38 - 1.05; p=0.074) and 17 weeks (HR=0.83, 95% CI 0.50-1.38; p=0.461) respectively, compared to 12 weeks with docetaxel alone.(2)

In this study, treatment with vandetanib was associated with asymptomatic QT prolongation (extended time interval between heartbeats). Other common adverse events (AEs) included diarrhea and rash. All AEs responded to standard management or dose interruption or reduction.

Due to the small number of patients involved, and the fact that survival data was potentially confounded by subsequent therapies, further assessment of survival outcomes will be investigated in Phase III trials. There was no significant effect of vandetanib on overall survival.

About Lung cancer

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.(3)

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%.(4)

Non-Small Cell Lung Cancer is the most common type of Lung Cancer, making up nearly 80% of all cases. This type of Lung Cancer grows and spreads more slowly than small cell lung cancer. Non-small cell lung cancer is divided into three different subcategories. Squamous cell carcinoma originates in the thin, flat cells that line the passages of the respiratory tract. Adenocarcinoma begins in the cells that form the lining of the lungs. Large cell carcinomas make up a group of cancers that look large and abnormal under a microscope.

About vandetanib (ZACTIMA)

Vandetanib is being studied as a multitargeted compound, directed to the inhibition of key cell signaling pathways involved in tumor growth and spread. Tumor cells are targeted through inhibition of epidermal growth factor receptor (EGFR) and REarranged during Transfection (RET) tyrosine kinases, while tumor blood supply is targeted through inhibition of vascular endothelial growth factor receptor (VEGFR) tyrosine kinase. RET tyrosine kinase activity is an important growth driver in certain lung tumors.

Other studies currently recruiting within the NSCLC Phase III clinical development program are:

-- ZEAL (ZACTIMA Efficacy (or Evaluation) with Alimta in Lung cancer)

-- ZEN (ZACTIMA efficacy in EGFR Failures in Non-small cell lung cancer)

-- ZEST (ZACTIMA Efficacy when Studied versus Tarceva)

The primary endpoints for these studies are PFS and OS.

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

About AstraZeneca

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 $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: http://www.astrazeneca-us.com

References

1 J Clin Oncol 25:4270-4277, 2007

2 Heymach JV JBPDea. A phase II trial of ZD6474 plus docetaxel in

patients with previously treated NSCLC: Follow-up results. 2006.

3 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.

4 Bepler G. Lung cancer epidemiology and genetics. Journal of Thoracic

Imaging 1999;14(4):228-34.


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SOURCE AstraZeneca
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