Blueprint
FORM 6-K
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
Report
of Foreign Issuer
Pursuant
to Rule 13a-16 or 15d-16 of
the
Securities Exchange Act of 1934
For the
month of September
2017
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
Indicate
by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F.
Form
20-F X Form 40-F __
Indicate
by check mark if the registrant is submitting the Form 6-K in paper
as permitted by Regulation S-T Rule 101(b)(1):
Indicate
by check mark if the registrant is submitting the Form 6-K in paper
as permitted by Regulation S-T Rule 101(b)(7): ______
Indicate
by check mark whether the registrant by furnishing the information
contained in this Form is also thereby furnishing the information
to the Commission pursuant to Rule 12g3-2(b) under the Securities
Exchange Act of 1934.
Yes __
No X
If
“Yes” is marked, indicate below the file number
assigned to the Registrant in connection with Rule 12g3-2(b):
82-_____________
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(primary
endpoint)
|
18.9
months (median)
|
10.2
months (median)
|
HR
0.4695% CI, 0.37-0.57, p<0.0001
|
|
OS at
25% maturity
|
N/A
|
N/A
|
HR
0.6395% CI, 0.45-0.88, p=0.0068*
|
|
Duration
of Response (DoR)
|
17.2
months (median)
|
8.5
months (median)
|
N/A
|
|
Objective
Response Rate (ORR)
|
80%
|
76%
|
OR
1.280.85-1.93, 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
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorized.
Date:
11th
September 2017
|
|
By: /s/
Adrian Kemp
|
|
|
Name:
Adrian Kemp
|
|
|
Title:
Company Secretary
|