AstraZeneca (AZN) recently presented encouraging phase III data on its thyroid cancer candidate, vandetanib. Data showed that treatment with vandetanib resulted in a 54% reduction in the rate of disease progression compared to placebo. These results were presented at the annual meeting of the American Society of Clinical Oncology (ASCO).
In addition to achieving the primary endpoint of progression free survival, vandetanib also showed improvement compared to placebo in the secondary endpoints, which were objective response rate and disease control rate. AstraZeneca reported that the response rate in the vandetanib arm was 45%.
The randomized, double-blind, placebo-controlled, multi-center study, ZETA, was conducted in 331 patients suffering from advanced medullary thyroid cancer (MTC). Common adverse events included rash, diarrhea, hypertension, fatigue and headache.
Based on these encouraging results, AstraZeneca intends to go ahead with its regulatory filings for vandetanib in both the US and the EU. Vandetanib enjoys orphan drug designation in the U.S. and Europe for the advanced medullary thyroid cancer indication.
According to the National Cancer Institute, about 37,000 new cases of thyroid cancer are detected each year in the U.S. Medullary tumors are the third most common of all thyroid cancers.
We note that AstraZeneca has previously experienced failure with its development plans for vandetanib. In June 2009, AstraZeneca had filed for approval of vandetanib for its use along with chemotherapy for the treatment of patients with advanced non-small-cell lung cancer (NSCLC).
However, AstraZeneca had to withdraw the regulatory submissions from both the U.S. and the EU as an updated analysis of results showed no overall survival advantage when vandetanib was added to chemotherapy. Moreover, the regulatory authorities had indicated that the data submitted by AstraZeneca might not be sufficient for approval.
Although the market for medullary thyroid cancer may not be huge, vandetanib, once approved, should be able to capture a significant share of the market as no approved treatments are currently available.
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