First Phase III Trial With Definitive Results In Advanced Medullary Thyroid Cancer Shows Statistically Significant Extension of Progression Free Survival For Patients
LONDON, June 7 /PRNewswire-FirstCall/ -- AstraZeneca announced
today 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.
(Logo: http://photos.prnewswire.com/prnh/20091027/PH99766LOGO
)
ZETA was a phase III, randomized, double-blind,
placebo-controlled, multi-center 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 tumor. 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, diarrhea, 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."
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.
About AstraZeneca
AstraZeneca (NYSE:AZN)
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.
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Source: AstraZeneca
CONTACT: US Media Inquiries: Laurie Casaday, AstraZeneca,
+1-302-885-2699, or Mob: +1-302-290-2624, Laurie.Casaday@AstraZeneca.com
or
Emily Denney, AstraZeneca, +1-302-885-3451, or Mob:
+1-302-897-4953,
Emily.Denney@AstraZeneca.com
or Global Media Inquiries: Ben Strutt,
AstraZeneca, +44 (0) 1625 230076, Mob: +44 (0) 7919 565990,
Ben.Strutt@AstraZeneca.com
Web Site: http://www.astrazeneca-us.com/
Posted: June 2010
