AZ’s Tagrisso brings ‘unprecedented’ benefit in untreated NSCLC

AstraZeneca says its lung cancer drug Tagrisso has produced "unprecedented" survival benefit from first-line use in some patients with advanced disease.

The UK pharma company tested the drug in first line in patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer.

Originally developed as a treatment for patients whose cancers develop a single amino acid mutation that blocks the action of AZ’s older EGFR drug, Iressa, the FLAURA trial investigated whether Tagrisso (osimertinib) is more effective than its predecessor and rivals in first line use.

The data is important to AZ, as it is attempting to rebuild its portfolio of drugs as key medicines begin to lose their patent protection.

Iressa’s EU patent expired around a year ago, and its US patent is due to expire in the coming years, so finding a more effective alternative in the same indication could help AZ build market share in this lucrative indication.

With sales of $955 million last year, Tagrisso is AZ’s top selling cancer drug, and sales are growing fast after a first approval in 2015.

New data from the phase 3 FLAURA trial showed that fewer patients on 1st-line Tagrisso had discontinued treatment compared to patients on the EGFR-TKI comparator arm (49% vs. 77%) and 29% received a subsequent treatment compared to 46% on the comparator arm.

Median time to first subsequent therapy or death was 23.5 months for those treated with 1st-line Tagrisso versus 13.8 months) for patients on the older drugs, Roche/Astellas Tarceva (erlotinib) or AZ’s own Tagrisso (gefitinib).

Patients treated with first-line Tagrisso experienced a longer time before discontinuation of EGFR-TKI therapy – a median 23.0 months, compared to a median of 16.0 months for comparator arm patients, which included patients who had crossed over to Tagrisso in the second line.

First-line Tagrisso patients had almost half the risk of second progression or death (PFS2) compared to the comparator arm.

AZ acknowledged that these data, based on what are termed "post-progression outcomes" instead of the gold standard overall survival figure, are increasingly helping inform choices about which drugs should be used, and in what order, as the disease develops.

Sean Bohen, chief medical officer at AstraZeneca, said: "These findings build on the clinically-meaningful (progression-free survival) benefit of Tagrisso and reinforce its potential as a new standard of care."

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