AstraZeneca pill slows thyroid cancer progression

Mon Jun 7, 2010 9:00am EDT

* Vandetanib shows 54 pct reduction in rate of progression

* Astra to file drug for medullary thyroid cancer in Q3

* Opens niche market after setback in lung cancer last year

By Ben Hirschler

LONDON, June 7 (Reuters) - An AstraZeneca (AZN.L) pill that disappointed last year in lung cancer has produced good results in treating a type of thyroid cancer, a much smaller potential market.

Patients with advanced medullary thyroid cancer (MTC) given vandetanib experienced a 54 percent reduction in the rate at which their disease progressed compared to those taking a placebo, results of a late-stage study showed on Monday.

Peter Langmuir, executive director of medical science, told Reuters that AstraZeneca would use the data to file for regulatory approval in MTC during the third quarter of 2010.

Vandetanib had previously been known as Zactima. However, the company is no longer using this name because it didn't receive regulatory permissions for the brand in all countries.

The medicine had once been seen as a potential blockbuster but it suffered a big setback after failing to show an overall survival benefit in lung cancer, leading AstraZeneca to pull regulatory filings in that disease last October.

Consensus forecast point to sales of around $200 million in 2014, according to Thomson Reuters data.

The Anglo-Swedish company has placed a big bet on cancer pills like vandetanib, although so far the strategy has met with limited success. Iressa, a pill for lung cancer, has seen a revival in its fortunes thanks to tests to identify those patients who will gain from using it. But another cancer pill, Recentin, was recently dropped as a candidate for first-line colon cancer. [ID:nLDE64R059]

Results of the two-year Phase III trial of vandetanib, involving 331 patients, were presented at the annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago.

Those on placebo went a median 19 months before their tumours started growing. In the vandetanib arm, the median point was not reached, since fewer than half of patients had disease progression, but using statistical modelling researchers estimated that the median for the treated group would have been about 30 months.

A total of 45 percent of patients on the drug saw their tumours shrink.

Langmuir said the advantage was "quite striking". No overall survival benefit was observed in the two-year study, however, since only 15 percent of patients died and there was also an option for patients to cross over from placebo to vandetanib.

Common side effects of the drug -- which targets three biological pathways known as VEGF, EGFR and RET -- were diarrhoea, hypertension and rash.

MTC can be cured by surgery but there are currently no specific drugs available for patients whose disease has spread around the body or returns after surgery.

There are around 2,000 new MTC patients each a year in the United States and a similar number in Europe, of whom around half could benefit from vandetanib, AstraZeneca calculates.

"The numbers are quite small," Langmuir acknowledged.

AstraZeneca is also investigating vandetanib in earlier stage clinical trials for other types of thyroid cancer, as well as brain tumours and head and neck cancer. (Editing by Sharon Lindores)

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