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2017-07-27

AstraZeneca: AstraZeneca reports initial results from the ongoing MYSTIC trial in stage IV lung cancer

Imfinzi plus tremelimumab combination did not meet a primary endpoint
of progression-free survival compared to chemotherapy

The MYSTIC trial continues as planned to assess the additional primary
endpoints of overall survival for Imfinzi monotherapy and for the
Imfinzi plus tremelimumab combination

AstraZeneca and MedImmune, its global biologics research and
development arm, today announced progression-free survival (PFS)
results for the Phase III MYSTIC trial, a randomised, open-label,
multi-centre, global trial of Imfinzi (durvalumab) monotherapy or
Imfinzi in combination with tremelimumab versus platinum-based
standard-of-care (SoC) chemotherapy in previously-untreated patients
with metastatic (Stage IV) 1st-line non-small cell lung cancer
(NSCLC).

The combination of Imfinzi and tremelimumab did not meet the primary
endpoint of improving PFS compared to SoC in patients whose tumours
express PD-L1 on 25% or more of their cancer cells (as determined by
the VENTANA PD-L1 (SP263) assay).

As a secondary endpoint, although not formally tested, Imfinzi
monotherapy would not have met a pre-specified threshold of PFS
benefit over SoC in this disease setting.

The trial will continue to assess two additional primary endpoints of
overall survival (OS) for Imfinzi monotherapy and OS for the Imfinzi
plus tremelimumab combination. Final OS data from both primary
endpoints are expected during the first half of 2018.

Sean Bohen, Executive Vice President, Global Medicines Development and
Chief Medical Officer at AstraZeneca, said: "While the results from
the MYSTIC trial for progression free survival in first-line Stage IV
non-small cell lung cancer compared with standard of care are
disappointing, the trial was designed to assess overall survival and
we look forward to evaluating the remaining primary endpoints of
overall survival for both mono- and combination therapy."

AstraZeneca recently received accelerated approval from the US FDA for
Imfinzi in previously-treated patients with locally advanced or
metastatic urothelial carcinoma (mUC).

About MYSTIC
The MYSTIC trial is a randomised, open-label, multi-centre, global
Phase III trial of Imfinzi monotherapy or Imfinzi in combination with
tremelimumab versus SoC in treatment of patients with epidermal
growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK)
wild-type locally-advanced or metastatic (Stage IV) 1st-line NSCLC.
Lung cancer is an unapproved use of Imfinzi.

The trial is being conducted in 167 centres across 17 countries,
including the US, Canada, Europe, parts of Asia including Japan,
Korea, Thailand, Taiwan and Vietnam, and in Russia and Australia.
Primary endpoints include PFS and OS.

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 mUC and in head and neck squamous cell
carcinoma (HNSCC). The combination of Imfinzi and tremelimumab is
being assessed in Phase III trials in mUC, NSCLC, SCLC and HNSCC and
in Phase I/II trials in hepatocellular carcinoma (HCC) and
haematological malignancies.

About Tremelimumab

Tremelimumab is an investigational human monoclonal antibody that
targets the activity of cytotoxic T-lymphocyte-associated protein 4
(CTLA-4). Tremelimumab blocks the activity of CTLA-4, contributing to
T cell activation and boosting the immune response to cancer.
Tremelimumab is being investigated in an extensive clinical trial
programme in combination with Imfinzi, in NSCLC, mUC, HNSCC, HCC and
blood cancers.

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 ongoing FLAURA and ADAURA trials.
Our extensive late-stage immuno-oncology programme focuses on 75-80%
of patients with NSCLC without a known genetic mutation. Our
portfolio includes Imfinzi (durvalumab), an anti-PDL1 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 and POSEIDON trials).

About AstraZeneca's approach to Immuno-Oncology

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-PDL1) 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 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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