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AstraZeneca: European Commission approves Imfinzi for locally-advanced, unresectable NSCLC

Phase III PACIFIC trial demonstrated compelling overall survival
benefit and progression-free survival of more than 11 months

Imfinzi is the only immunotherapy medicine approved for the treatment
of locally-advanced, unresectable NSCLC

AstraZeneca and MedImmune, its global biologics research and
development arm, today announced that the European Commission has
granted marketing authorisation for Imfinzi (durvalumab) as
monotherapy for the treatment of locally-advanced, unresectable
non-small cell lung cancer (NSCLC) in adults whose tumours express
PD-L1 on ?1% of tumour cells and whose disease has not progressed
following platinum-based chemotherapy and radiation therapy (CRT).
The approval is based on results from the Phase III PACIFIC trial.

Dave Fredrickson, Executive Vice President, Head of the Oncology
Business, said: "Patients in Europe diagnosed with locally-advanced,
unresectable non-small cell lung cancer now have a new treatment
option. Imfinzi is the only immunotherapy to be approved in this
curative-intent setting, and we are proud to bring a new standard of
care for this difficult disease."

Dr. Luis Paz-Ares, co-principal investigator of the PACIFIC trial,
from the Hospital Universitario Doce de Octubre, Madrid, Spain, said:
"Lung cancer is the leading cause of cancer-related death in Europe
and approximately a third of European patients with NSCLC present
with locally-advanced disease. For decades, the standard of care for
these patients has been chemotherapy and radiation therapy followed
by active surveillance, after which the majority of patients progress
to advanced disease. Imfinzi has demonstrated a compelling survival
benefit for these patients in this area of significant unmet need."

The approval follows the positive opinion
on 27 July 2018 from the CHMP of the European Medicines Agency.

The most common adverse reactions (greater than or equal to 20% of
patients) of Imfinzi versus placebo were cough (40.2% vs. 30.3%),
upper respiratory tract infections (26.1% vs 11.5%) and rash (21.7%
vs 12.0%). 12.8% of patients experienced a grade 3 or 4 AE with
Imfinzi vs 9.8% with placebo.

Imfinzi is approved for the treatment of patients with unresectable,
Stage III (locally-advanced) NSCLC in the US, Canada, Switzerland,
India, Japan and Brazil. Other global health authority reviews and
submissions are ongoing.

About Stage III NSCLC

Stage III (locally-advanced) NSCLC is divided into three
sub-categories (IIIA, IIIB and IIIC), defined by how much the cancer
has spread locally and the possibility of surgery. Stage III disease
is different from Stage IV disease, when the cancer has spread
(metastasised) to distant organs, as Stage III is currently treated
with curative intent.

Stage III NSCLC represents approximately one-third of NSCLC incidence
and was estimated to affect around 105,000 patients in the top-eight
countries (China, France, Germany, Italy, Japan, Spain, UK, US) in
2017. The majority of Stage III NSCLC patients are diagnosed with
unresectable tumours. No new treatments beyond chemoradiation
therapy, followed by active surveillance to monitor for progression,
have been available to patients for decades.


The PACIFIC trial is a Phase III, randomised, double-blinded,
placebo-controlled, multi-centre trial of Imfinzi as treatment in
`all-comer' patients (i.e. regardless of PD-L1 status) with
unresectable, Stage III (locally-advanced) NSCLC whose disease has
not progressed following platinum-based chemotherapy and radiation
therapy (CRT).

The trial is being conducted in 235 centres across 26 countries
involving 713 patients. 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) is a human monoclonal antibody that binds to
PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80,
countering the tumour's immune-evading tactics and releasing the
inhibition of immune responses.

Imfinzi is approved for unresectable, Stage III NSCLC in the US,
Canada, Switzerland, India, Japan, and Brazil based on the Phase III
PACIFIC trial. Imfinzi is also approved for the treatment of patients
with locally-advanced or metastatic urothelial carcinoma in the US,
Canada, Brazil, Israel, Hong Kong, and India.

As part of a broad development programme, Imfinzi is also being tested
as a monotherapy and in combination with chemotherapy, radiation
therapy, small molecules, and tremelimumab, an anti-CTLA4 monoclonal
antibody, as a first or second-line treatment for patients with
NSCLC, small-cell lung cancer, locally-advanced or metastatic
urothelial carcinoma, head and neck cancer and other solid tumours.

About AstraZeneca in Lung Cancer

Lung cancer is the leading cause of cancer death among both men and
women, accounting for about one-third of all cancer deaths.

AstraZeneca has a comprehensive portfolio of approved and potential
new medicines in late-stage clinical development for the treatment of
different forms of lung cancer across all stages of disease and lines
of therapy. We aim to address the 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
ongoing FLAURA, ADAURA and LAURA Phase III trials. Our extensive
late-stage immuno-oncology programme focuses on 75-80% of patients
with lung cancer without a known genetic mutation. Imfinzi, an
anti-PDL1 antibody is in development as monotherapy (ADJUVANT BR.31,
PACIFIC2, MYSTIC and PEARL Phase III trials) and in combination with
tremelimumab and/or chemotherapy (MYSTIC, NEPTUNE, POSEIDON and
CASPIAN Phase III 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 clear majority of patients.

We are pursuing a comprehensive clinical trial programme that includes
Imfinzi (anti-PDL1) as monotherapy and in combination with
tremelimumab (anti-CTLA4) 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 advancing Oncology as a growth driver for AstraZeneca,
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, Renal & 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

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 therapy areas - Oncology, Cardiovascular, Renal & Metabolism
and Respiratory. AstraZeneca operates in over 100 countries and its
innovative medicines are used by millions of patients worldwide.

For more information, please visit and follow us
on Twitter @AstraZeneca.


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Rob UK/Global +44 203 749 5821
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Michele US +1 302 885 2677

Thomas +44 203 749 5712
Henry Oncology +44 203 749 5797
Christer Cardiovascular; Metabolism +44 203 749 5711
Nick Stone Respiratory; Renal +44 203 749 5716
Josie Other +44 203 749 5631
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Jennifer Retail Investors +44 203 749 5824


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