A sign is seen at an AstraZeneca site in Macclesfield
(Copyright Reuters 2016)
LONDON – AstraZeneca, the pill Tagrisso cut the risk of lung cancer an increase of 70 percent compared with standard chemotherapy in a large clinical trial, raising the prospects for a medicine that is the key to the company’s high long-term goals.
The medicine is designed to help cancer patients with certain genetic mutations that are very common in China and other parts of east Asia.
Tagrisso is already on the market, winning early approval on the basis of mid-stage studies, and sales of $276 million in the first nine months of 2016, but AstraZeneca was required to produce a confirmatory Phase III, randomized study in which the benefits.
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Results released on Tuesday, showed that Tagrisso, given as a second-line treatment, helped patients live an average of 10.1 months before their disease getting worse, compared with 4.4 months for those on chemotherapy. Tagrisso patients also had fewer drug-related side effects.
AstraZeneca said that it would continue to monitor patients to see whether the improvement in progression-free survival also translated into the time in a higher overall survival.
The lung cancer pill is an important part of AstraZeneca’s goal is to lift sales to $45 billion in 2023. The company set that goal in response to a takeover attempt by Pfizer in 2014, with Tagrisso forecast to contribute $3 billion.
At the time, many analysts saw the Tagrisso target as very ambitious. Nevertheless, consensus forecasts are now increased to $2.5 billion to 2022, according to Thomson Reuters data, helped by the strong start and the failure of some competing products.
Sean Bohen, AstraZeneca’s chief medical officer, told Reuters, the latest data showed “a quite extraordinary advantage,” especially if Tagrisso also produced better results than chemotherapy in patients whose cancer had spread to the brain.
Brain tumors are an important consideration in lung cancer, since 25% to 40% of patients with brain metastases at some point in their disease.
The results of the trial, involving 419 patients, in whom the disease was progressed after the use of a so-called EGFR-inhibitor drug such as AstraZeneca’s Iressa or Roche’s Tarceva, were presented at the World Conference on Lung Cancer, and published online in the New England Journal of Medicine.
AstraZeneca is also assessing Tagrisso as first-line treatment in non-small cell lung cancer clinical trial that will report results for the coming year.
The drug, already approved in the major Western markets and Japan, is currently in the fast track review in China, where almost half of the patients with lung cancer are thought to have the EGFR mutation. By comparison, EGFR mutation, lung cancer accounts for only 10-15 percent of the cases in Europe and the United States.