MEDIA RELEASE PR41195
Vandetanib Phase II Trial Shows Significant Improvement of Progression Free Survival in Patients With
Advanced Papillary or Follicular Thyroid Cancer
PARIS, Sept. 12 /PRNewswire-AsiaNet/ --
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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 thyroid cancer."
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.
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.
SOURCE: AstraZeneca
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