Paris (ots/PRNewswire) - AstraZeneca today announced
results from a phase II study evaluating the investigational drug
vandetanib for the treatment of patients with locally advanced or
metastatic papillary or follicular thyroid cancer. This study,
ZACTHYF, showed that treatment with vandetanib significantly improved
Progression Free Survival (PFS), the primary endpoint of the study,
compared to placebo (Hazard Ratio=0.63, p=0.008). Median PFS was
improved by 5 months (11.0 months for vandetanib and 5.8 months for
placebo patients). The results of the ZACTHYF study were presented
today at the International Thyroid Congress in Paris.
ZACTHYF is a phase II, randomised, double blind, placebo
controlled, multi-centre study, which compared oral once-daily
vandetanib 300mg to placebo in 145 patients with locally advanced or
metastatic papillary or follicular thyroid cancer who failed
treatment with, or were unsuitable for, radioiodine therapy.
"Papillary and follicular thyroid cancer are the most common
forms of thyroid cancer and these results show evidence of vandetanib
activity in patients with advanced metastatic disease where there are
few treatment options after surgery and treatment with radioactive
iodine," said Peter Langmuir, M.D. Executive Director,
Medical-Science, AstraZeneca, "This adds to previous data which shows
vandetanib to be the first therapy to demonstrate improved efficacy
vs placebo in a phase III trial in patients with advanced medullary
There were no significant differences observed in ZACTHYF between
vandetanib and placebo groups across the secondary efficacy endpoints
of objective response rate, disease control rate at six months and
overall survival. The safety profile of vandetanib is consistent
across all thyroid studies. The most common adverse events are
diarrhoea, asthenia, fatigue, hypertension, decreased appetite,
nausea, acne, rash and QTc prolongation.
AstraZeneca plans regulatory submissions in 2010 for the
treatment of patients with advanced medullary thyroid cancer.
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.
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: http://www.astrazeneca.com.
ots Originaltext: AstraZeneca
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CONTACT: Global Media Inquiries: Ben Strutt, Global
OncologyCommunications Director, AstraZeneca, Tel: +44(0)1625-230076,
Mob:+44(0)7919-565990, Email: Ben.Strutt@AstraZeneca.com .