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AstraZeneca: The European Medicines Agency accepts marketing authorisation application for Imfinzi in locally-advanced unre...

AstraZeneca, along with MedImmune, its global biologics research and
development arm, has announced that the European Medicines Agency
(EMA) has accepted a Marketing Authorisation Application (MAA) 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. This is the first registrational submission
for Imfinzi in the European Union.

The MAA 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 MAA 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



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 2016[1]
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.


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

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

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

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.

Esra Erkal UK/Global +44 203 749 5638
Karen UK/Global +44 203 749 5634
Rob UK/Global +44 203 749 5821
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Henry Oncology +44 203 749 5797
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