First Phase III Trial With Definitive Results in Advanced Medullary Thyroid Cancer Shows Statistically Significant Extension of Progression Free Survival for Patients

Monday, June 7, 2010 General News
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LONDON, June 7, 2010 Results from ZETA, a phaseIII study in patients with advanced medullary thyroid cancer (MTC), showedthat treatment with the investigational drug vandetanib significantlyextended Progression Free Survival (PFS), the primary endpoint of the study,by demonstrating a 54% reduction in the rate of progression compared toplacebo (HR=0.46, p=0.0001). The results of the ZETA study were presentedtoday at the American Society of Clinical Oncology (ASCO) annual meeting inChicago.

ZETA was a phase III, randomised, double-blind, placebo-controlled,multi-centre study, evaluating oral once-daily vandetanib 300mg in 331patients with unresectable, locally advanced or metastatic hereditary orsporadic medullary thyroid cancer and the presence of a measurable tumour.This was the first phase III trial with definitive results, carried out forpatients with advanced MTC.

Significant differences for vandetanib compared to placebo were alsoobserved in secondary endpoints of objective response rate and diseasecontrol rate--the response rate in patients receiving vandetanib was 45%.Patients receiving vandetanib also had a significant decrease in calcitoninand CEA biomarkers. Overall survival (OS) data at the time of presentationwas 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%. Thesafety profile of vandetanib in this study was similar to what has beenpreviously observed in other studies in medullary thyroid and non small celllung cancer.

"Patients with advanced medullary thyroid cancer currently have few or nooptions for treatment once they reach this late stage of their disease", saidPeter Langmuir, M.D. Executive Director, Medical-Science, AstraZeneca. "Giventhe results of this trial, we are moving quickly to file regulatorysubmissions for approval with the FDA and the EMA."

Vandetanib 300mg has orphan drug designation in the US and Europe for thetreatment of patients with advanced medullary thyroid cancer and AstraZenecaplans regulatory submissions in 2010. Vandetanib is thought to work byinhibition of the vascular endothelial growth factor (VEGF) pathway,epidermal growth factor receptor (EGFR) and rearranged during transfection(RET) pathways.

About Vandetanib

Vandetanib blocks the development of tumour blood supply by inhibition ofthe VEGF pathway, and by inhibiting the growth and survival of the tumourthrough EGFR and RET pathways.

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical businesswith a primary focus on the discovery, development and commercialisation ofprescription medicines. As a leader in gastrointestinal, cardiovascular,neuroscience, respiratory and inflammation, oncology and infectious diseasemedicines, AstraZeneca generated global revenues of US $32.8 billion in 2009.For more information please visit:

This press release has been made available on worldwide presscommunication media for the benefit of correspondents writing for the medicalprofessional press. Differing national legislation, codes of practice,medical practice etc mean that you should contact your local AZ press officeto obtain information designed for use in your country.

SOURCE AstraZeneca

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