AstraZeneca has the improvement in overall survival (OS) it needed for lung cancer therapy Tagrisso (osimertinib), as it tries to double down on its use in the first-line setting.
Updated results from the FLAURA trial show that Tagrisso extends survival in previously-untreated patients with EGFR-positive non-small cell lung cancer (NSCLC), building on 2017 results showing that the drug could extend progression-free survival (PFS).
The improvement in OS came over other drugs in the EGFR inhibitor class, namely AZ’s own Iressa (gefitinib) and Roche’s Tarceva (erlotinib), and according to AZ’s head of oncology José Baselga it is the only medicine to achieve this outcome.
AZ’s head of oncology José Baselga
“Tagrisso provides an unprecedented survival outcome versus previous standard-of-care [EGFR] inhibitors” in first-line EGFR-mutated NSCLC, he said, and that means it should be the new standard therapy for this indication.
Tagrisso had previously shown a trend towards improvement in OS in FLAURA, but earlier readouts were too immature to show a statistically-significant benefit.
Now, the new data should help AZ continue to build momentum with Tagrisso at a time when the EGFR inhibitor category is becoming increasingly competitive, with new entrants such as Pfizer’s Vizimpro (dacomitinib) jostling for market share.
It will also help the company make its case to payers. For example, AZ is in the midst of an appeal against a decision by UK cost-effectiveness body NICE to turn down Tagrisso in first-line EGFR-positive NSCLC treatment, in part because the OS data was inconclusive compared to the older, cheaper rivals.
NICE also judged that the drug would not eligible for inclusion in the Cancer Drugs Fund, saying it was too expensive, while at the same time it recommended Pfizer’s Vizimpro for routine NHS use in this indication.
Tagrisso is already dominating the second-line EGFR-positive NSCLC market and AZ has been working hard to push the new drug into the first-line setting, with what seems to be some success in many markets.
In its first-half results, AZ reported that sales of Tagrisso, now comfortably its top-selling drug, almost doubled to $1.4bn, with the growth spurred by first-line use in the US, Europe and Japan and second-line use in China. AZ thinks the drug could reach $3bn this year on current growth rates.