AZ's lung cancer drug Tagrisso gets boost from first line OS results

AstraZeneca has announced figures confirming that its Tagrisso extends overall survival in patients with untreated non-small cell lung cancer with certain mutations, compared with older alternatives.

The phase 3 FLAURA trial had already met its primary endpoint of improving progression-free survival in July 2017 – but AZ said that the latest figures confirm that Tagrisso extends patients’ lives as well as slowing the spread of the disease compared with standard treatments.

FLAURA compared Tagrisso with AZ’s predecessor drug Iressa (gefitinib) and Roche’s Tarceva (erlotinib) in previously untreated patients with locally-advanced or metastatic non-small cell lung cancer whose tumours have epidermal growth factor receptor (EGFR) mutations.

There were also no surprises in terms of safety and tolerability, the company said, although it did not reveal further clinical details.

Detailed results will be presented at a forthcoming medical meeting, AZ said.

Tagrisso was first FDA approved in 2015 in patients whose disease has progressed following therapy with Iressa and other EGFR tyrosine kinase inhibitors, because of a single amino acid mutation known as T790M that blocks their action and tends to arise by chance after prolonged treatment.

But midway through last year regulators in the US and Europe approved the drug as a first-line treatment, following progression-free survival (PFS) results from FLAURA.

FLAURA showed that in patients treated with Tagrisso, median PFS was 18.9 months, compared with 10.2 months in a group of patients treated with standard care.

This has helped to boost sales considerably and it is now AZ’s top-selling drug, bringing in revenues of more than $1.4 billion in the first half of the year, up 86% from last year's first half.

Sales from Tagrisso, and AZ's other recently approved cancer drugs Lynparza and Imfinzi are helping to turn the company's fortunes around after several blockbusters lost patent protection.

Jose Baselga, AZ’s executive vice president of oncology R&D, said: “Today’s positive results show that Tagrisso provides an unprecedented survival outcome versus previous standard-of-care epidermal growth factor receptor tyrosine kinase inhibitors, reaffirming Tagrisso as the 1st-line standard-of-care for EGFR-mutated metastatic non-small cell lung cancer.”