Zactima extends progression free survival in other thyroid cancers
pharmafile | September 13, 2010 | News story | Research and Development | thyroid cancer, zactima
New data suggests patients with the more common forms of thyroid cancer respond to AstraZeneca’s Zactima.
The drug has already shown promising results in the rarest form – medullary thyroid cancer – and the new data suggests patients with locally advanced or metastatic papillary or follicular types of the disease also benefit.
The ZACTHYF study shows the drug extends progression free survival in these patients by five months compared to placebo.
The phase II study of Zactima (vandetanib) in locally advanced or metastatic papillary or follicular types of the disease could be a step forward in treating the cancer.
The ZACTHYF study showed that treatment with Zactima significantly improved Progression Free Survival (PFS) with patients taking the drug averaging 11.0 months compared to those on placebo averaging 5.8 month.
The news consolidates Zactima’s evidence ahead of a planned filing in medullary thyroid cancer by the end of 2010. AstraZeneca had originally filed the drug as a lung cancer treatment in 2009, but poor results forced it to withdrawn its application.
The good news did not extend to secondary endpoints, however. There were no significant differences observed between Zactima and placebo groups in objective response rate and disease control rate at six months. There is also no data to suggest the drug can extend overall survival.
“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, executive director of medical-science, AstraZeneca,
“This adds to previous data which shows vandetanib to be the first therapy to demonstrate improved efficacy versus placebo in a phase III trial in patients with advanced medullary thyroid cancer.”
Thyroid cancer papillary accounts for around 60% of cases and follicular represent around 15% of all cases of the disease.
The results are presented today at the International Thyroid Congress in Paris. ZACTHYF is a phase II trial comparing oral once-daily Zactima 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.
AstraZeneca say the safety profile of Zactima 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.
Zactima is thought to work by inhibiting the vascular endothelial growth factor (VEGF) pathway, epidermal growth factor receptor (EGFR) and rearranged during transfection (RET) pathways.
Andrew McConaghie
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