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 October
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-_____________
17 October 2017 07:00 BST
US FDA ACCEPTS SUPPLEMENTAL BIOLOGICS LICENSE APPLICATION FOR
IMFINZI IN LOCALLY ADVANCED
UNRESECTABLE NON-SMALL CELL LUNG CANCER
Imfinzi granted Priority Review
Acceptance follows FDA's Breakthrough Therapy
Designation
AstraZeneca
and MedImmune, its global biologics research and development arm,
today announced that the US Food and Drug Administration (FDA) has
accepted a supplemental Biologics License Application (sBLA) for
Imfinzi (durvalumab) for
the treatment of patients with locally advanced (Stage III)
unresectable non-small cell lung cancer (NSCLC) whose disease has
not progressed following platinum-based chemoradiation therapy. The
FDA has granted Imfinzi
Priority Review status.
The US
FDA sBLA submission acceptance is an important milestone for
Imfinzi in a disease state
where patients need better treatment options and outcomes.
Currently, the standard of care for patients with this earlier
stage of lung disease is active monitoring following concurrent
chemoradiation.
The
sBLA submission is based on positive progression-free
survival (PFS) data from the Phase III PACIFIC trial. The
trial continues to evaluate overall survival (OS), its other
primary endpoint. Detailed results of the PACIFIC trial,
including additional safety information, were published online in
the New
England Journal of Medicine.
On 28
September 2017, the US NCCN Clinical Practice Guidelines in
Oncology (NCCN Guidelines) were updated to include Imfinzi for the treatment of patients
with locally-advanced unresectable NSCLC with no disease
progression after two or more cycles of definitive chemoradiation,
based on the data from the PACIFIC Phase III trial. This indication
is not yet FDA-approved.
About Locally Advanced (Stage III) NSCLC
Locally
advanced (Stage III) lung cancer is commonly 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 distant organs.
Stage
III lung cancer represents approximately one-third of NSCLC
incidence and was estimated to affect around 105,000 patients in
the top-7 countries in 20161. More than 70% 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 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 has already received accelerated approval in the US
for the treatment of patients with locally advanced or metastatic
urothelial carcinoma, who have disease progression during or
following platinum-containing chemotherapy, or whose disease has
progressed within 12 months of receiving platinum-containing
chemotherapy before (neoadjuvant) or after (adjuvant)
surgery.
As part
of a broad development programme, Imfinzi is also being investigated for
the adjuvant treatment of patients with NSCLC in the CCTG (Canadian
Cancer Trials Group) trial ADJUVANT (BR31). In the MYSTIC, NEPTUNE,
and PEARL Phase III trials, Imfinzi is being studied for 1st-line
treatment as monotherapy and/or in combination with tremelimumab,
an anti-CTLA-4 monoclonal antibody, for the treatment of metastatic
NSCLC. The POSEIDON trial is investigating Imfinzi with and without tremelimumab
in combination with chemotherapy in the same
population.
About AstraZeneca in Lung Cancer
AstraZeneca
is committed to developing medicines to help every patient with
lung cancer. We have two 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'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.
|
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
|
|
Gonzalo
Viña
|
UK/Global
|
+44 203
749 5916
|
|
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
1France, Germany, Italy,
Japan, Spain, United Kingdom, United States
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:
17 October 2017
|
|
By: /s/
Adrian Kemp
|
|
|
Name:
Adrian Kemp
|
|
|
Title:
Company Secretary
|