Zactima promising in rare thyroid cancer
pharmafile | June 11, 2010 | News story | Research and Development, Sales and Marketing | AstraZeneca, thyroid cancer, zactima
AstraZeneca’s Zactima (vandetanib) will be filed with regulators later this year as a treatment for thyroid cancer after promising results.
The company has unveiled phase III results in patients with advanced medullary thyroid cancer (MTC), showing vandetanib significantly extended Progression Free Survival (PFS).
Medullary thyroid carcinoma is a rare form of the disease, representing only 5-9% of all thyroid cancers.
Patients on the trial showed a 54% reduction in the rate of progression compared to placebo. However, AstraZeneca says it is still too early to say if the drug can prolong the lives of patients with the disease.
The results are good news for the drug, which has been a disappointment against non-small cell lung cancer, a far more common condition.
Vandetanib is thought to work by blocking three pathways – vascular endothelial growth factor (VEGF), epidermal growth factor receptor (EGFR) and rearranged during transfection (RET).
The results were presented at the American Society of Clinical Oncology (ASCO) meeting in Chicago.
“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, executive director of medical-science at AstraZeneca. “Given the results of this trial, we are moving quickly to file regulatory submissions for approval with the FDA and the EMA.”
ZETA was a phase III 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.
The most common adverse events in the study were rash, diarrohea, 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.
Andrew McConaghie
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