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 July 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-_____________
31 July 2017 07:00
BST
IMFINZI GRANTED
BREAKTHROUGH THERAPY DESIGNATION BY US FDA FOR PATIENTS WITH
LOCALLY-ADVANCED UNRESECTABLE NON-SMALL CELL LUNG
CANCER
Fourth Breakthrough Therapy Designation for an AstraZeneca New
Oncology medicine in three years
AstraZeneca
and MedImmune, its global biologics research and development arm,
today announced that the US Food and Drug Administration (FDA) has
granted Breakthrough Therapy Designation for Imfinzi (durvalumab) for the treatment
of patients with locally-advanced, unresectable non-small cell lung
cancer (NSCLC) whose disease has not progressed following
platinum-based chemoradiation therapy.
Sean
Bohen, Executive Vice President, Global Medicines Development and
Chief Medical Officer at AstraZeneca, said: "For patients who have
not progressed following chemoradiation therapy the only current
option is active monitoring. Unfortunately, for the majority of
patients, their cancer will progress to metastatic disease,
typically within 12 months. Imfinzi is the first immuno-oncology
medicine to show a clinically-significant benefit in this earlier,
non-metastatic setting, so following the Breakthrough Designation
we hope to bring it to patients as soon as possible."
The
Breakthrough Therapy Designation is designed to expedite the
development and regulatory review of new medicines that are
intended to treat a serious condition and that have shown
encouraging early clinical results, which demonstrate substantial
improvement on a clinically-significant endpoint over available
medicines and when there is significant unmet medical
need.
The
Breakthrough Therapy Designation for Imfinzi was granted on the basis of
interim results from the Phase III PACIFIC
trial, a randomised, double-blinded, placebo-controlled
multi-centre trial of Imfinzi as sequential treatment in
patients with locally-advanced, unresectable (Stage III) NSCLC who
had not progressed following standard platinum-based chemotherapy
concurrent with radiation therapy. This achievement follows the
recent accelerated approval from the US FDA for Imfinzi in previously-treated patients
with advanced bladder cancer, and is the fourth Breakthrough
Therapy Designation AstraZeneca has received from the FDA for a New
Oncology cancer medicine over the past three years, the second for
Imfinzi.
Data
from the PACIFIC trial have been submitted for presentation at a
forthcoming medical meeting.
Imfinzi is also being tested in the adjuvant NSCLC setting
in the ADJUVANT Phase III trial. In the Stage IV 1st-line setting
for patients with advanced NSCLC, Imfinzi as monotherapy and in
combination with tremelimumab, an anti-CTLA4, is being tested in
the MYSTIC, NEPTUNE, and PEARL Phase III trials. The POSEIDON trial
is evaluating Imfinzi with
and without tremelimumab in combination with
chemotherapy.
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,
including the US, Canada, Europe, South and Central America, Japan,
Korea, Taiwan, South Africa and Australia. The primary endpoints of
the trial are PFS and OS, and secondary endpoints include landmark
PFS and OS, objective response rate 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 (HCC) and
haematological malignancies.
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 metastasised to other
organs.
Stage
III lung cancer represents approximately one third of NSCLC
incidence and was estimated to affect around 100,000 patients in
the G7 countries in 2016. About 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 AstraZeneca in NSCLC
Lung
cancer is the leading cause of cancer death among both men and
women, accounting for about one-third of all cancer deaths and more
than breast, prostate and colorectal cancers combined.
AstraZeneca
has a comprehensive portfolio of approved and potential new
medicines in late-stage clinical development for the treatment of
NSCLC across all stages of disease and lines of therapy. We aim to
address unmet needs of patients with EGFR-mutated tumours as a
genetic driver of disease, which occur in 10-15% of NSCLC patients
in the US and EU and 30-40% of NSCLC patients in Asia, with our
approved medicines Iressa
and Tagrisso and on-going
FLAURA and ADAURA trials for Tagrisso. Our extensive late-stage
immuno-oncology programme focuses on 75-80% of patients with NSCLC
without a known genetic mutation. Our portfolio includes
Imfinzi, an anti-PD-L1
antibody, which is in development as monotherapy (ADJUVANT,
PACIFIC, MYSTIC, PEARL and ARCTIC trials) and in combination with
tremelimumab, an anti-CTLA-4 (MYSTIC, NEPTUNE, ARCTIC and POSEIDON
trials).
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 program 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
|
|
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
|
|
Lindsey
Trickett
|
Cardiovascular
& Metabolic Diseases
|
+1 240
543 7970
|
|
Nick
Stone
|
Respiratory
|
+44 203
749 5716
|
|
Christer
Gruvris
|
Autoimmunity,
Neuroscience & Infection
|
+44 203
749 5711
|
|
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.
AstraZeneca
PLC
|
Date:
31 July 2017
|
By: /s/
Adrian Kemp
|
|
|
Name:
Adrian Kemp
|
|
|
Title:
Company Secretary
|