AstraZeneca says that new data from its FLAURA trial of EGFR inhibitor Tagrisso makes a compelling argument that the drug should be use ahead of other dugs in the class in newly-diagnosed patients.
The company says post-progression data – which evaluates the time between disease progression on the first-line therapy to the start of second- or late-line therapy – reinforces the benefit of using Tagrisso (osimertinib) first-line in EGFR-mutated non-small cell lung cancer (NSCLC).
Earlier data from FLAURA have shown that AZ’s drug improved progression-free survival (PFS) versus older EGFR inhibitors erlotinib (Roche’s Tarceva) and gefitinib (AZ’s Iressa), and has supported regulatory filings as a front-line therapy for EGFR-mutated NSCLC.
Tagrisso is already on the cusp of blockbuster sales status after becoming the standard for second-line treatment, but the prospect of approval in previously-untreated patients has stimulated debate about the best order to deliver EGFR drugs, as they all eventually succumb to resistance and lose efficacy over time.
The new results indicate that when Tagrisso is given first-line, it almost halves the risk of a second progression or death compared to Tarceva and Iressa, according to Sean Bohen, AZ’s chief medical officer.
In the analysis, the median time to first subsequent therapy or death was 23.5 months for patients treated with Tagrisso, compared to 13.8 months for those on erlotinib or gefitinib. Moreover, fewer patients on first-line Tagrisso discontinued treatment than in the comparator arm, and just 29% needed a subsequent treatment compared to 46% on erlotinib or gefitinib.
“These findings build on the clinically-meaningful PFS benefit of Tagrisso and reinforce its potential as a new standard of care,” said Bohen. Unlocking the market for previously-untreated EGFR-mutated NSCLC is seen as central to AZ’s ambitions for Tagrisso, which is one of its top growth prospects.
In making the case for Tagrisso AZ acknowledges that post-progression data isn’t a wholly recognised endpoint in cancer studies, which generally focus on PFS and overall survival (OS) data.
In a blog post, the company’s global clinical lead for oncology, Yuri Rukazenkov, said that while OS remains the gold-standard measure of efficacy in cancer, using post-progression data can not only help researchers to establish whether a drug should be used first or later in the treatment schedule, but “can also establish the optimal sequence of treatment – and this can have a real impact on patient outcomes”.