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
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United
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82-_____________
11 September 2017 07:00 BST
ASTRAZENECA PRESENTS SUPERIOR PROGRESSION-FREE SURVIVAL FOR
IMFINZI IN THE PACIFIC
TRIAL OF PATIENTS WITH LOCALLY-ADVANCED UNRESECTABLE LUNG CANCER AT
ESMO 2017 CONGRESS
Imfinzi improves progression-free survival (PFS) by more than 11
months compared to standard of care and is the first medicine to
show superior PFS in this setting
Data presented at the ESMO 2017 Congress follows FDA's recent
Breakthrough Therapy Designation for Imfinzi in locally advanced,
unresectable lung cancer
The PACIFIC trial continues to evaluate the other primary endpoint,
overall survival
AstraZeneca
and MedImmune, its global biologics research and development arm,
have presented the full PFS data from a planned interim analysis of
the Phase III PACIFIC trial. Results show that Imfinzi (durvalumab) demonstrated a
statistically-significant and clinically-meaningful improvement in
PFS compared to current standard of care with active surveillance
in patients with locally-advanced (Stage III), unresectable
non-small cell lung cancer (NSCLC) who had not progressed following
standard platinum-based chemotherapy concurrent with radiation
therapy (CRT).
Results
of the Phase III PACIFIC trial, included at the Presidential
Symposium I of the European Society of Medical Oncology (ESMO) 2017
Congress in Madrid, Spain, show an improvement in PFS of more than
11 months in patients treated with Imfinzi compared to placebo (full
details in table below). The PFS improvement with Imfinzi was observed across all
pre-specified subgroups, including PD-L1 expression status.
Patients receiving Imfinzi
also had a lower incidence of metastases than those receiving
placebo. The PACIFIC trial continues to evaluate overall survival
(OS), the other primary endpoint. Detailed results of the PACIFIC
trial are published online in the
New England Journal of Medicine.
Sean
Bohen, Executive Vice President, Global Medicines Development and
Chief Medical Officer at AstraZeneca, said: "The Phase III PACIFIC
results are incredibly encouraging for a patient population that
until now has been without treatment options. As the first
Immuno-Oncology medicine to achieve improvement in progression-free
survival in this setting, Imfinzi is showing clear potential to
become a new standard of care for patients with locally-advanced,
unresectable NSCLC who have not progressed following
chemoradiation."
Dr.
Luis Paz-Ares, Principal Investigator of the PACIFIC trial, from
the Hospital Universitario Doce de Octubre, Madrid, Spain, said:
"For patients with locally-advanced unresectable NSCLC who have
completed chemoradiation therapy, Imfinzi represents a potential new
treatment option in the context of clear unmet clinical need.
Durvalumab overtly prolongs the period in which the disease is
controlled with reasonable side effects. In addition, it offers
hope to increase the cure rate in this setting, but more mature
follow-up is needed to assess its impact on survival."
Summary
of key efficacy results:
|
Endpoint
|
Medicine
|
Value
|
Hazard ratio (HR)/Confidence interval (CI)
|
|
PFS*(first
primary endpoint)
|
Imfinzi
|
16.8
months (median)
|
HR
0.5295% CI, 0.42-0.65, p<0.0001
|
|
Placebo
|
5.6
months(median)
|
|
Duration
of response (DoR)
|
Imfinzi
|
Not
reached
|
N/A
|
|
Placebo
|
13.8
months
|
|
Objective
Response Rate (ORR) as measured from baseline scan post-CRT
completion
|
Imfinzi
|
28.4%
|
95% CI,
24.28-32.89, p<0.001
|
|
Placebo
|
16.0%
|
95% CI,
11.31-21.59, p<0.001
|
* Time from randomisation to the first documented tumour
progression, or death in the absence of progression. Randomisation
in the PACIFIC trial occurred up to 6 weeks after completion of
concurrent chemoradiation therapy (cCRT) and cCRT typically lasted
at least 6 weeks. If the PFS had been measured prior to cCRT,
it would add approximately 3 months or longer to the PFS value for
each arm.
Among
patients receiving Imfinzi,
the most frequent treatment-related adverse events (AEs) vs.
placebo were cough (35.4% vs 25.2%), pneumonitis/radiation
pneumonitis (33.9% vs 24.8%), fatigue (23.8% vs 20.5%), dyspnoea
(22.3% vs 23.9%) and diarrhoea (18.3% vs 18.8%). 29.9% of patients
experienced a grade 3 or 4 AE vs. 26.1% for placebo, and 15.4% of
patients discontinued treatment due to AEs compared to 9.8% of
patients on placebo.
On 31
July 2017, Imfinzi received
Breakthrough Therapy Designation from the US Food and Drug
Administration (FDA) as a potential treatment for patients with
locally advanced, unresectable NSCLC whose disease has not
progressed following platinum-based chemoradiation
therapy.
AstraZeneca
is in discussions with global health authorities regarding
regulatory submissions for Imfinzi based on the PACIFIC data. A
status of regulatory submissions is usually provided with the
Company's quarterly results announcement.
Imfinzi received accelerated approval from the US Food and
Drug Administration for previously treated patients with advanced
bladder cancer and is under review in Canada and Australia for
similar use.
About Locally Advanced (Stage III) NSCLC
Stage
III lung cancer is divided into two stages (IIIA and IIIB), which
are defined by how much the cancer has spread locally and the
possibility of surgery. This differentiates it from Stage IV
disease, when the cancer has spread (metastasised) to other
organs.
Stage
III lung cancer represents approximately one-third of NSCLC
incidence and was estimated to affect around 105,000 patients in
the G7 countries in 2016. More than half of these patients have
tumours that are unresectable. The current standard of care is
chemotherapy and radiation followed by active surveillance to
monitor for progression. The prognosis remains poor and long-term
survival rates are low.
About PACIFIC
The
PACIFIC trial is a randomised, double-blinded, placebo-controlled,
multi-centre trial of Imfinzi as sequential treatment in
unselected patients with locally-advanced, unresectable (Stage III)
NSCLC who have not progressed following platinum-based chemotherapy
concurrent with radiation therapy.
The
trial is being conducted in 235 centres across 26 countries
involving approximately 700 patients. The primary endpoints of the
trial are progression-free survival (PFS) and overall survival
(OS), and secondary endpoints include landmark PFS and OS,
objective response rate (ORR) and duration of
response.
About Imfinzi
Imfinzi (durvalumab), a human monoclonal antibody directed
against PD-L1, blocks PD-L1 interaction with PD-1 and CD80 on T
cells, countering the tumour's immune-evading tactics and inducing
an immune response.
Imfinzi continues to be studied in multiple monotherapy
trials and combination trials with tremelimumab and other potential
new medicines in Immuno-Oncology. Imfinzi is being assessed in Phase III
trials as a monotherapy in various stages of NSCLC, in small-cell
lung cancer (SCLC), in metastatic urothelial cancer (mUC) and in
head and neck squamous cell carcinoma (HNSCC). The combination of
Imfinzi and tremelimumab is
being assessed in Phase III trials in NSCLC, SCLC, mUC and HNSCC
and in Phase I/II trials in hepatocellular carcinoma and
haematological malignancies.
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's Approach to Immuno-Oncology (IO)
Immuno-Oncology
(IO) is a therapeutic approach designed to stimulate the body's
immune system to attack tumours. At AstraZeneca and MedImmune, our
biologics research and development arm, our IO portfolio is
anchored by immunotherapies that have been designed to overcome
anti-tumour immune suppression. We believe that IO-based therapies
will offer the potential for life-changing cancer treatments for
the vast majority of patients.
We are
pursuing a comprehensive clinical trial programme that includes
Imfinzi (anti-PD-L1)
monotherapy and in combination with tremelimumab (anti-CTLA-4) in
multiple tumour types, stages of disease, and lines of therapy,
using the PD-L1 biomarker as a decision-making tool to define the
best potential treatment path for a patient. In addition, the
ability to combine our IO portfolio with small, targeted molecules
from across our oncology pipeline, and with those of our research
partners, may provide new treatment options across a broad range of
tumours.
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 MedImmune
MedImmune
is the global biologics research and development arm of
AstraZeneca, a global, innovation-driven biopharmaceutical business
that focuses on the discovery, development and commercialisation of
small molecule and biologic prescription medicines. MedImmune is
pioneering innovative research and exploring novel pathways across
Oncology; Respiratory, Cardiovascular & Metabolic Diseases; and
Infection and Vaccines. The MedImmune headquarters is located in
Gaithersburg, Md., one of AstraZeneca's three global R&D
centres, with additional sites in Cambridge, UK, and Mountain View,
CA. For more information, please visit
www.medimmune.com.
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.
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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
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By: /s/
Adrian Kemp
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|
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Name:
Adrian Kemp
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Title:
Company Secretary
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