TIDMAZN
RNS Number : 3067Q
AstraZeneca PLC
11 September 2017
11 September 2017 07:00 BST
ASTRAZENECA'S TAGRISSO SHOWS POTENTIAL AS A NEW STANDARD OF CARE
IN 1ST-LINE EGFR-MUTATED LUNG CANCER AT ESMO 2017 CONGRESS
Phase III FLAURA trial results show Tagrisso reduced the risk of
progression or death by more than half, with consistent benefit
across all subgroups, including patients with and without brain
metastases
Unprecedented median progression-free survival (PFS) of 18.9
months compared with 10.2 months for the current standard of
care
Clinically-meaningful preliminary overall survival benefit
AstraZeneca has presented the full results of the Phase III
FLAURA trial, which support Tagrisso's (osimertinib) clear
potential as a new standard of care (SoC) in the 1st-line treatment
of adult patients with locally-advanced or metastatic epidermal
growth factor receptor (EGFR)-mutated non-small cell lung cancer
(NSCLC).
Results of the Phase III FLAURA trial were included at the
Presidential Symposium I of the European Society of Medical
Oncology (ESMO) 2017 Congress in Madrid, Spain, and demonstrate a
superior, clinically-meaningful PFS advantage with Tagrisso
compared with current SoC EGFR-TKIs (erlotinib or gefitinib).
Sean Bohen, Executive Vice President, Global Medicines
Development and Chief Medical Officer at AstraZeneca, said: "The
FLAURA data are truly exciting. Until now, even with the
therapeutic advances offered by the first- and second-generation
EGFR inhibitors, less than 20% of EGFR mutation-positive NSCLC
patients survive for five years. The FLAURA data suggest early and
sustained benefit with Tagrisso that has the potential to
significantly impact long-term patient outcomes and help address
the considerable unmet need that remains."
Dr. Suresh S. Ramalingam, Principal Investigator of the FLAURA
trial, from the Winship Cancer Institute of Emory University,
Atlanta, USA, said: "The FLAURA data for osimertinib are likely to
result in a major paradigm shift in the treatment of patients with
EGFR mutation-positive advanced lung cancer. Not only did the trial
demonstrate a robust improvement in efficacy with osimertinib when
compared to other commonly-used EGFR inhibitors, the side effects
profile was also more favourable with osimertinib".
Summary of key efficacy results:
Endpoint Tagrisso SoC Hazard ratio (HR)/
Odds ratio (OR)
----------------- ------------ ------------ ----------------------
PFS 18.9 months 10.2 months HR 0.46
(median) (median)
(primary 95% CI, 0.37-0.57,
endpoint) p<0.0001
----------------- ------------ ------------ ----------------------
OS at 25% N/A N/A HR 0.63
maturity
95% CI, 0.45-0.88,
p=0.0068*
----------------- ------------ ------------ ----------------------
Duration of 17.2 months 8.5 months N/A
Response (DoR) (median) (median)
----------------- ------------ ------------ ----------------------
Objective
Response Rate
(ORR) 80% 76% OR 1.28
0.85-1.93, p=0.2335
----------------- ------------ ------------ ----------------------
*0.0015 was the threshold required for statistical significance
at the current level of maturity. A final OS analysis is planned at
a later stage.
Additional highlights from the FLAURA data include:
-- Superior progression-free survival (PFS): Patients on
Tagrisso had less than half the risk of progression or death
compared with patients on erlotinib or gefitinib (hazard ratio [HR]
0.46; 95% confidence interval [CI] 0.37-0.57; p<0.0001). The
median PFS was 18.9 months for patients on Tagrisso vs.10.2 months
for patients in the comparator arm.
-- Clinically-meaningful preliminary overall survival (OS) data
at 25% maturity: The hazard ratio for OS was 0.63 (95% CI:
0.45-0.88; p=0.0068) favouring Tagrisso. Overall survival data were
25% mature at the time of the interim analysis (21% of the patients
on Tagrisso had died and 30% of the patients on the comparator arm
had died). The p-value of 0.0068 was not below the threshold of
0.0015 required for statistical significance at the current level
of maturity. A final OS analysis is planned at a later stage.
-- PFS improvements consistent across subgroups: Improvements in
PFS with Tagrisso were consistent across all pre-specified patient
subgroups, with at least a 40% reduction in the risk of progression
or death, including in patients with/without central nervous system
(CNS) metastases at study entry, Asian/non-Asian patients, patients
with/without prior smoking history, and patients with exon 19
deletion/L858R.
-- Impressive duration of response (DoR) and objective response
rate (ORR): Patients treated with Tagrisso had more than double the
median DoR than those on the comparator arm (17.2 months vs. 8.5
months), and an ORR (a measurement of tumour shrinkage) of 80% vs.
76% with the comparator arm (odds ratio 1.28 [0.85-1.93],
p=0.2335).
The FLAURA safety data for Tagrisso were in line with those
observed in prior clinical trials, with a low rate of Grade >=3
adverse events (AEs). In patients treated with Tagrisso, the most
common AEs were diarrhoea (58% [2% Grade >=3]) and dry skin (32%
[<1% Grade >=3]), and in the comparator arm group, the most
common AEs were diarrhoea (57% [3% Grade >=3]) and dermatitis
acneiform (48% [5% Grade >=3]). Of the patients on Tagrisso,
33.7% had a Grade >=3 AE, compared with 44.8% in the comparator
arm, and 13.3% of patients on Tagrisso had an AE leading to
treatment discontinuation compared with 18.1% in the comparator
arm.
AstraZeneca is in discussions with global health authorities
regarding regulatory submissions for Tagrisso based on the FLAURA
data. A status of regulatory submissions is usually provided with
the Company's quarterly results announcement.
Tagrisso is currently approved in more than 50 countries,
including the US, EU, Japan and China, as 2nd-line treatment for
patients with advanced NSCLC who progress following treatment with
an EGFR-TKI due to the EGFR T790M resistance mutation.
About EGFR-mutated NSCLC
Lung cancer is the leading cause of cancer death among both men
and women, accounting for about one-quarter 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 EGFRm NSCLC. These patients are
particularly sensitive to treatment with currently-available
EGFR-TKIs, which block the cell signalling pathways that drive the
growth of tumour cells. However, tumours almost always develop
resistance to EGFR-TKI treatment, leading to disease progression.
Approximately half of patients develop resistance to approved
EGFR-TKIs such as gefitinib and erlotinib due to the resistance
mutation, EGFR T790M. Tagrisso also targets this secondary mutation
that leads to disease progression. There is also a need for agents
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 FLAURA
FLAURA assessed the efficacy and safety of Tagrisso 80mg orally
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 a double-blinded, randomised study, with
556 patients across 30 countries.
The primary endpoint of the trial was PFS, and secondary
endpoints included OS, ORR, DOR, disease control rate (DCR),
safety, and measures of health-related quality of life (HRQoL).
About Tagrisso
Tagrisso is a third-generation, irreversible EGFR tyrosine
kinase inhibitor (TKI) designed to inhibit both EGFR sensitising
and EGFR T790M resistance mutations, with clinical activity against
central nervous system (CNS) metastases. Tagrisso (osimertinib)
40mg and 80mg once-daily oral tablets have been approved in more
than 50 countries, including the US, EU, Japan and China, for
patients with EGFR T790M mutation-positive advanced NSCLC. Tagrisso
is also being investigated in the adjuvant and metastatic 1st-line
settings, including in patients with and without CNS metastases, in
leptomeningeal metastases, and in combination with other
treatments.
About AstraZeneca in Lung Cancer
AstraZeneca is committed to developing therapies to help every
patient with lung cancer. We have two approved therapies 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 New Oncology as one of AstraZeneca's five
Growth Platforms 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 main therapy areas - Oncology, Cardiovascular & Metabolic
Diseases 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.
Media Relations
Esra Erkal-Paler UK/Global +44 203 749 5638
Karen Birmingham UK/Global +44 203 749 5634
Rob Skelding UK/Global +44 203 749 5821
Matt Kent UK/Global +44 203 749 5906
Jacob Lund Sweden +46 8 553 260 20
Michele Meixell US +1 302 885 2677
Investor Relations
Thomas Kudsk Larsen +44 203 749 5712
Craig Marks Finance, Fixed Income, M&A +44 7881 615 764
Henry Wheeler Oncology +44 203 749 5797
Mitchell Chan Oncology +1 240 477 3771
Christer Gruvris Diabetes; Autoimmunity, Neuroscience & Infection +44 203 749 5711
Nick Stone Respiratory; Brilinta +44 203 749 5716
US toll free +1 866 381 7277
Adrian Kemp
Company Secretary, AstraZeneca PLC
This information is provided by RNS
The company news service from the London Stock Exchange
END
MSCXBLLFDKFZBBX
(END) Dow Jones Newswires
September 11, 2017 02:01 ET (06:01 GMT)
Astrazeneca (LSE:AZN)
Historical Stock Chart
From Mar 2024 to Apr 2024
Astrazeneca (LSE:AZN)
Historical Stock Chart
From Apr 2023 to Apr 2024