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EMBARGOED UNTIL 2 PM BST, June 7, 2010
AstraZeneca
News Release
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FIRST PHASE III TRIAL WITH DEFINITIVE RESULTS IN ADVANCED MEDULLARY
THYROID CANCER SHOWS STATISTICALLY SIGNIFICANT EXTENSION OF
PROGRESSION FREE SURVIVAL FOR PATIENTS
(London, UK – 2pm, 7th June, 2010)— Results from ZETA, a phase III study in patients
with advanced medullary thyroid cancer (MTC), showed that treatment with the
investigational drug vandetanib significantly extended Progression Free Survival (PFS), the
primary endpoint of the study, by demonstrating a 54% reduction in the rate of progression
compared to placebo (HR=0.46, p=0.0001). The results of the ZETA study were presented
today at the American Society of Clinical Oncology (ASCO) annual meeting in Chicago.
ZETA was a phase III, randomised, double-blind, placebo-controlled, multi-centre study,
evaluating oral once-daily vandetanib 300mg in 331 patients with unresectable, locally
advanced or metastatic hereditary or sporadic medullary thyroid cancer and the presence of
a measurable tumour. This was the first phase III trial with definitive results, carried out for
patients with advanced MTC.
Significant differences for vandetanib compared to placebo were also observed in secondary
endpoints of objective response rate and disease control rate--the response rate in patients
receiving vandetanib was 45%. Patients receiving vandetanib also had a significant
decrease in calcitonin and CEA biomarkers. Overall survival (OS) data at the time of
presentation was immature.
The most common adverse events associated with vandetanib in this study, included rash,
diarrhoea, hypertension, fatigue and headache (incidence >20% overall). The incidence of
protocol-defined QTc prolongation was 8%. The safety profile of vandetanib in this study was
similar to what has been previously observed in other studies in medullary thyroid and non
small cell lung cancer.
“Patients with advanced medullary thyroid cancer currently have few or no options for
treatment once they reach this late stage of their disease”, said Peter Langmuir, M.D.
Executive Director, Medical-Science, AstraZeneca. “Given the results of this trial, we are
moving quickly to file regulatory submissions for approval with the FDA and the EMA.”
EMBARGOED UNTIL 2 PM BST, June 7, 2010
Vandetanib 300mg has orphan drug designation in the US and Europe for the treatment of
patients with advanced medullary thyroid cancer and AstraZeneca plans regulatory
submissions in 2010. Vandetanib is thought to work by inhibition of the vascular endothelial
growth factor (VEGF) pathway, epidermal growth factor receptor (EGFR) and rearranged
during transfection (RET) pathways.
-endsAbout Vandetanib
Vandetanib blocks the development of tumour blood supply by inhibition of the VEGF
pathway, and by inhibiting the growth and survival of the tumour through EGFR and RET
pathways.
About AstraZeneca
AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus
on the discovery, development and commercialisation of prescription medicines. As a leader
in gastrointestinal, cardiovascular, neuroscience, respiratory and inflammation, oncology and
infectious disease medicines, AstraZeneca generated global revenues of US $32.8 billion in
2009. For more information please visit: www.astrazeneca.com.
For further information please contact:
Global Media Inquiries:
Ben Strutt, Global PR Director, AstraZeneca
Tel: +44 (0) 1625 230076
Mob: +44 (0) 7919 565990
Email: [email protected]