AZ's Tagrisso shines in lung cancer trial

AstraZeneca has announced data that it says will establish its lung cancer drug Tagrisso as standard second line treatment in patients with certain mutations.

The data showed Tagrisso (osimertinib) slowed tumour progression compared with standard chemotherapy and was also more effective in patients with brain metastases – a group with a much worse prognosis.

Tagrisso is approved in second line non-small cell lung cancer (NSCLC) with epidermal growth factor receptor and a T790M mutation, following tyrosine kinase inhibitor treatment.

The AURA3 phase 3 trial showed Tagrisso improved progression-free survival by 5.7 months compared with standard chemotherapy, a substantial improvement.

Progression-free survival in the Tagrisso arm of the 419-patient trial was 10.1 months, compared with 4.4 months in the chemotherapy arm.

The news is very welcome for AstraZeneca, which has endured a rough ride in 2016, as its  blockbuster cholesterol drug, Crestor (rosuvastatin) has gone off-patent and saw setbacks to its cardiovascular drug Brilinta and immunotherapy candidate durvalumab.

Tagrisso is shaping up to be one of the company's best performers, and AZ now predicts it can reach peak of $3 billion. This will help towards chief executive Pascal Soriot achieving his ambitious pledge to reach an overall revenue target of $45 billion for 2023.

Tagrisso still has to overcome regulatory hurdles as it is only conditionally approved in the US and EU, but the latest data should make that process a formality.

In the UK, cost-effectiveness body NICE has ruled that Tagrisso will only be funded on an interim basis through the Cancer Drugs Fund, until the company can provide stronger survival data.

Risk of disease progression was 70% lower in patients treated with Tagrisso. In patients with central nervous system metastases, Tagrisso increased progression-free survival by 4.3 months compared with chemotherapy.

Sales of Tagrisso were around $133 million in Q3 – a strong performance given it was only approved in the US late last year, and in Europe earlier this year.

Sean Bohen, executive vice president, global medicines development and chief medical officer at AstraZeneca, said: “The confirmatory phase 3 data suggest the potential for Tagrisso to replace chemotherapy as the standard of care for patients who have progressed following EGFR tyrosine kinase inhibitor treatment.

"As lung cancer is the most common type of cancer to spread to the brain, it is also encouraging to see the activity of Tagrisso in patients with central nervous system metastases whose prognosis is often particularly poor.”

Tagrisso's position has been consolidated by the failure of its closest rival. Clovis earlier this year abandoned development of a rival drug in this indication, rociletinib, after FDA advisers became concerned about data pointing to a risk of sudden cardiac death.