The company has announced positive OS results from the phase III randomised, double-blinded and multi-centre trial of Tagrisso in previously-untreated patients with locally-advanced or metastatic non-small cell lung cancer (NSCLC) whose tumours have EGFR mutations.
Tagrisso demonstrated a statistically-significant and clinically-meaningful improvement in OS, a secondary endpoint in the phase III trial, compared against erlotinib or gefitinib both of which were previous standard-of-care (SoC) treatments in this setting.
With 556 patients across 29 countries, the Flaura study evaluated the efficacy and safety of Tagrisso 80mg orally once daily against comparator EGFR-TKIs (either erlotinib [150mg orally, once daily] or gefitinib [250mg orally, once daily]) in previously untreated patients with locally-advanced or metastatic EGFRm NSCLC.
In July 2017, the company achieved its primary endpoint by demonstrating a statistically-significant and clinically-meaningful improvement in progression-free survival (PFS).
Tagrisso is a third-generation and irreversible EGFR-TKI designed to restrict inhibit both EGFR-sensitising and EGFR T790M-resistance mutations, with clinical activity against central nervous system metastases.
At present, the drug secured approval in 74 countries, including the US, Japan and the EU, for first-line EGFRm metastatic NSCLC.
Tagrisso 40mg and 80mg once-daily oral tablets have secured approval in more than70 countries, while for second-line use in patients with EGFR T790M mutation-positive advanced NSCLC in over 80 countries.
It is also being developed in the adjuvant setting in the adjuvant setting in Adaura trial, as well as in the locally-advanced unresectable setting in the Laura trial and in combination with chemotherapy in the Fluara 2 trial.
AstraZeneca oncology R&D executive vice president José Baselga 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.”
In July this year, AstraZeneca’s oncology immunotherapy Imfinzi (durvalumab) has been granted orphan drug designation (ODD) for the treatment of small cell lung cancer (SCLC).