Policy & Regulation
Tagrisso "Significantly Improves" Overall Survival in the Phase III FLAURA Trial for 1st-line EGFR-mutated Non-small Cell Lung Cancer
12 August 2019 - - Anglo-Dutch biopharmaceutical company AstraZeneca has received positive overall survival results from the Phase III FLAURA trial, a randomized, double-blinded, multicenter trial of TAGRISSO in previously-untreated patients with locally-advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor mutations, the company said.

TAGRISSO showed a statistically-significant and clinically-meaningful improvement in OS, a secondary endpoint in the FLAURA Phase III trial, compared with erlotinib or gefitinib both of which were previous standard-of-care treatments in this setting.

The FLAURA trial met its primary endpoint in July 2017, showing a statistically-significant and clinically-meaningful improvement in progression-free survival, increasing the time patients lived without disease progression or death from any cause.

The safety and tolerability of TAGRISSO was consistent with its established profile.

AstraZeneca plans to present the OS results from the FLAURA trial at a forthcoming medical meeting.
TAGRISSO is currently approved in more than 74 countries, including the US, Japan and the EU, for 1st-line EGFR-mutated metastatic NSCLC.

Lung cancer is the leading cause of cancer death among both men and women, accounting for about one-fifth of all cancer deaths, more than breast, prostate and colorectal cancers combined. Lung cancer is broadly split into NSCLC and small cell lung cancer, with 80-85% classified as NSCLC.

Approximately 10-15% of NSCLC patients in the US and Europe, and 30-40% of patients in Asia have EGFR-mutated (EGFRm) NSCLC.

These patients are particularly sensitive to treatment with EGFR TKIs which block the cell-signaling pathways that drive the growth of tumor cells.

Approximately 25% of patients with EGFR-mutated NSCLC have brain metastases at diagnosis, increasing to approximately 40% within two years of diagnosis. The presence of brain metastases often reduces median survival to less than eight months.

TAGRISSO (osimertinib) is a third-generation, irreversible EGFR TKI designed to inhibit both EGFR-sensitizing and EGFR T790M-resistance mutations, with clinical activity against central nervous system metastases.

TAGRISSO 40mg and 80mg once-daily oral tablets have now received approval in more than 70 countries, including the US, Japan and the EU, for 1st-line EGFR-mutated advanced NSCLC, and in more than 80 countries, including the US, Japan, China and the EU, for 2nd-line use in patients with EGFR T790M mutation-positive advanced NSCLC.

TAGRISSO is also being developed in the adjuvant setting (ADAURA trial), in the locally-advanced unresectable setting (LAURA), in combination with chemotherapy (FLAURA2) and in combination with potential new medicines (SAVANNAH, ORCHARD).

The FLAURA trial assessed the efficacy and safety of TAGRISSO 80mg orally once daily vs. comparator EGFR-TKIs (either erlotinib [150mg orally, once daily] or gefitinib [250mg orally, once daily]) in previously-untreated patients with locally-advanced or metastatic EGFR-mutated NSCLC.

The trial was double-blinded and randomised, with 556 patients across 29 countries.

AstraZeneca has a comprehensive portfolio of approved and potential new medicines in late-stage clinical development for the treatment of different forms of lung cancer spanning several stages of disease, lines of therapy and modes of action.

We aim to address the unmet needs of patients with EGFR-mutated tumors as a genetic driver of disease, which occur in 10-15% of NSCLC patients in the US and EU and 30-40% of NSCLC patients in Asia, with our approved medicines gefitinib and TAGRISSO, and ongoing Phase III trials FLAURA, FLAURA2, ADAURA and LAURA as well as the Phase III exploratory combination trials SAVANNAH and ORCHARD.

Its late-stage Immuno-Oncology programme focuses on lung cancer patients without a known genetic mutation which represents up to 50% of all patients with lung cancer.
Login
Username:

Password: