AstraZeneca Plc (LON:AZN) today announced that the Japanese Ministry of Health, Labour and Welfare has approved Tagrisso (osimertinib) for the 1st-line treatment of patients with inoperable or recurrent epidermal growth factor receptor mutation-positive non-small cell lung cancer, following priority review. The approval is based on results from the global Phase III FLAURA trial which included Japanese patients and which were published in the New England Journal of Medicine.
Dave Fredrickson, Executive Vice President, Head of the Oncology Business Unit, said: “Tagrisso is already approved in Japan for the treatment of patients with EGFR T790M mutation-positive inoperable or recurrent NSCLC that is resistant to existing 1st-line EGFR-inhibitor medicines. Today’s approval moves the use of Tagrisso to the 1st-line setting, replacing older medicines which, given the high prevalence of the EGFR mutation in Japan, offers an important new treatment option for these patients.”
The FLAURA trial compared Tagrisso to current 1st-line EGFR tyrosine kinase inhibitors (TKIs), erlotinib or gefitinib in previously-untreated patients with locally-advanced or metastatic EGFR-mutated (EGFRm) NSCLC. In the trial, Tagrisso demonstrated superior progression-free survival (PFS) of 18.9 months compared with 10.2 months for the comparator arm (see table below), and this benefit was consistent across all subgroups including in patients with or without central nervous system (CNS) metastases, an important benefit for lung cancer patients.
FLAURA trial efficacy results according to investigator assessment
|
Efficacy parameter
|
Tagrisso |
EGFR-TKI comparator (gefitinib or erlotinib) (N=277) |
|
PFS |
||
|
Number of events (62% maturity) |
136 (49) |
206 (74) |
|
Median PFS (95% confidence interval [CI]) |
18.9 months (15.2, 21.4) |
10.2 months (9.6, 11.1) |
|
Hazard ratio (HR [95% CI]); p-value |
0.46 (0.37, 0.57); p < 0.0001 |
|
|
Objective response rate (ORR) |
||
|
Response rate (95% CI) |
80% (75, 85) |
76% (70, 81) |
|
Odds ratio (95% CI); p-value |
1.3 (0.9, 1.9); p=0.2421 |
|
|
Duration of response (DoR) |
||
|
Median DoR (95% CI) |
17.2 months (13.8, 22.0) |
8.5 months (7.3, 9.8) |
About Tagrisso
Tagrisso (osimertinib) is a third-generation, irreversible EGFR-TKI designed to inhibit both EGFR-sensitising and EGFR T790M-resistance mutations, with clinical activity against CNS metastases. Tagrisso 40mg and 80mg once-daily oral tablets have now received approval in 39 countries, including the US, Japan and in Europe, for 1st-line EGFRm advanced NSCLC, and more than 75 countries, including the US, Japan, China and in Europe, for 2nd-line use in patients with EGFR T790M mutation-positive advanced NSCLC. Tagrisso is also being developed in the adjuvant setting (ADAURA), in the locally-advanced unresectable setting (LAURA), and in combination with other treatments.
About AstraZeneca plc
AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas – Oncology, Cardiovascular, Renal & Metabolism and Respiratory. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.
