TIDMAZN
RNS Number : 8516Q
AstraZeneca PLC
08 June 2018
08 June 2018 17:30BST
The EU approves Tagrisso for 1st-line treatment of EGFR-mutated
non-small cell lung cancer
1st-line Tagrisso offers a potential new standard of care
Today the European Commission has granted marketing
authorisation for Tagrisso (osimertinib) as monotherapy for the
1st-line treatment of adult patients with locally-advanced or
metastatic non-small cell lung cancer (NSCLC) with activating
epidermal growth factor receptor (EGFR) mutations. The approval is
based on results from the Phase III FLAURA trial published in the
New England Journal of Medicine.
Dave Fredrickson, Executive Vice President, Head of the Oncology
Business Unit at AstraZeneca, said: "Today's approval is an
exciting advance in bringing a potential new standard of care to
patients with EGFR-mutated NSCLC in the EU. This milestone is also
a step forward for our Company, marking another regional approval
for Tagrisso in the 1st-line setting."
Dr. David Planchard, Associate Professor of Medicine, Head of
Thoracic Group, Gustave Roussy cancer center, France said: "The
FLAURA trial is changing medical practice in the 1st-line treatment
of EGFR-mutated NSCLC. The progression-free survival benefit seen
in the trial is unprecedented for patients with an EGFR mutation,
and this benefit was consistent across all subgroups including in
patients with or without central nervous system metastases.
Further, the preliminary overall survival data, while not
statistically significant at the time of the interim analysis, is
promising, with a 37 percent reduction in the risk of death."
The approval follows the positive opinion from the Committee for
Medicinal Products for Human Use (CHMP) of the European Medicines
Agency.
FLAURA efficacy results according to investigator assessment
Efficacy parameter Tagrisso EGFR-TKI comparator
(N=279) (gefitinib or
erlotinib)
(N=277)
---------------------------------- ------------------------- ----------------------
Progression-free survival (PFS)
-------------------------------------------------------------------------------------
Number of events (62% maturity) 136 (49) 206 (74)
---------------------------------- ------------------------- ----------------------
Median PFS (95% CI) 18.9 months 10.2 months
(15.2, 21.4) (9.6, 11.1)
---------------------------------- ------------------------- ----------------------
HR (95% CI); p-value 0.46 (0.37, 0.57); p < 0.0001
---------------------------------- -------------------------------------------------
Overall survival (OS)
-------------------------------------------------------------------------------------
Number of deaths, (25% maturity) 58 (21) 83 (30)
---------------------------------- ------------------------- ----------------------
Median OS in months (95% CI) NC NC
---------------------------------- ------------------------- ----------------------
HR (95% CI); p-value 0.63 (0.45, 0.88); p=0.0068 (NS)(*)
---------------------------------- -------------------------------------------------
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)
---------------------------------- ------------------------- ----------------------
*Not statistically significant at current level of maturity.
Safety data for Tagrisso from the FLAURA, AURA3, AURA and AURA2
trials were evaluated. Tagrisso was well tolerated, with most
adverse reactions Grade 1 or 2 in severity. In all patients, the
most common adverse reactions were decreased leucocytes (68% [1.5%
Grade >=3]), decreased lymphocytes (67% [7.2% Grade >=3]),
decreased platelet count (54% [1.6% Grade >=3]), diarrhoea (49%
[1.2% Grade >=3]), rash (47% [0.9% Grade >=3]), decreased
neutrophils (35% [4.1% Grade >=3]), dry skin (33% [0.1% Grade
>=3]), paronychia (31% [0.3% Grade >=3]), stomatitis (20%
[0.2% Grade >=3]), and pruritus (17% [0.1% Grade >=3]).
In the EU, Tagrisso is already indicated for the treatment of
patients with locally-advanced or metastatic EGFR T790M
mutation-positive NSCLC. Today's approval follows the recent
approvals of Tagrisso for the 1st-line treatment of patients with
metastatic EGFR-mutated (EGFRm) NSCLC in the US, Brazil and the
Russian Federation. Tagrisso is also under regulatory review in
Japan for use in the 1st-line treatment setting with a decision
anticipated in the second half of 2018, with other global health
authority reviews and submissions ongoing.
About 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.
Approximately 10-15% of 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-signalling pathways that drive the growth of tumour cells.
Tumours almost always develop resistance to EGFR-TKI treatment,
however, leading to disease progression. Approximately half of
patients develop resistance to approved EGFR-TKIs such as
gefitinib, erlotinib and afatinib due to the EGFR T790M resistance
mutation. There is also a need for medicines with improved CNS
efficacy, since approximately 25% of patients with EGFRm NSCLC have
brain metastases at diagnosis, increasing to approximately 40%
within two years of diagnosis.
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
been approved in four countries, including the US and EU, for
1st-line EGFRm advanced NSCLC, and in more than 75 countries
including the US, EU, Japan and China for patients with EGFR T790M
mutation-positive advanced NSCLC. Tagrisso is also being tested in
the adjuvant setting and in combination with other treatments.
About the FLAURA trial
The FLAURA trial assessed the efficacy and safety of Tagrisso
80mg once daily vs. standard-of-care 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. The trial was double-blinded and
randomised, with 556 patients across 29 countries.
About AstraZeneca in Lung Cancer
AstraZeneca is committed to developing medicines to help every
patient with lung cancer. We have three approved medicines and a
growing pipeline that targets genetic changes in tumour cells and
boosts the power of the immune response against cancer. Our
unrelenting pursuit of science aims to deliver more breakthrough
therapies with the goal of extending and improving the lives of
patients across all stages of disease and lines of therapy.
About AstraZeneca in Oncology
AstraZeneca has a deep-rooted heritage in Oncology and offers a
quickly-growing portfolio of new medicines that has the potential
to transform patients' lives and the Company's future. With at
least six new medicines to be launched between 2014 and 2020, and a
broad pipeline of small molecules and biologics in development, we
are committed to advance Oncology as a key growth driver for
AstraZeneca focused on lung, ovarian, breast and blood cancers. In
addition to our core capabilities, we actively pursue innovative
partnerships and investments that accelerate the delivery of our
strategy, as illustrated by our investment in Acerta Pharma in
haematology.
By harnessing the power of four scientific platforms -
Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage Response
and Antibody Drug Conjugates - and by championing the development
of personalised combinations, AstraZeneca has the vision to
redefine cancer treatment and one day eliminate cancer as a cause
of death.
About AstraZeneca
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. The Company also is selectively active
in the areas of autoimmunity, neuroscience and infection.
AstraZeneca operates in over 100 countries and its innovative
medicines are used by millions of patients worldwide.
For more information, please visit www.astrazeneca.com and
follow us on Twitter @AstraZeneca.
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