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2018-03-12

AstraZeneca: AstraZeneca provides update on MYSTIC trial timeline

AstraZeneca and MedImmune, its global biologics research and
development arm, today announced an updated timeline for the final
analysis of the Phase III MYSTIC trial of Imfinzi (durvalumab) as
monotherapy and 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).

MYSTIC is an event-driven clinical trial and continues per protocol.
Based on current predictions, the final analysis of overall survival
(OS) is now expected in the second half of 2018 (previously
anticipated in the first half).

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.

The trial is being conducted in 167 centres across 17 countries,
including the US, Canada, Europe, Russia, Australia and parts of Asia
including Japan, Korea, Thailand, Taiwan and Vietnam. Primary
endpoints include progression-free survival (in combination), which
read out in July 2017, and OS in monotherapy and in combination.

About Imfinzi

Imfinzi 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.

In February 2018, Imfinzi received US FDA approval for the treatment
of patients with unresectable Stage III NSCLC whose disease has not
progressed following concurrent platinum-based chemotherapy and
radiation therapy. Imfinzi has also 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 as a monotherapy and/or in combination with
tremelimumab, an anti-CTLA-4 monoclonal antibody and potential new
medicine, as a first 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 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, locally-advanced or
metastatic urothelial carcinoma, head and neck cancer, liver cancer
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, an anti-PDL1 antibody, which is in
development as monotherapy (ADJUVANT, PACIFIC, MYSTIC, PEARL and
ARCTIC trials) and in combination with tremelimumab (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 clear majority of patients.

We are pursuing a comprehensive clinical-trial programme that includes
Imfinzi (anti-PD-L1) as 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 Oncology as a growth platform 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 & Metabolic Diseases; and
Infection and Vaccines. The MedImmune headquarters is located in
Gaithersburg, US., one of AstraZeneca's three global R&D centres,
with additional sites in Cambridge, UK, and Mountain View, US. 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 therapy areas - Oncology, Cardiovascular, Renal & Metabolism
and Respiratory. The Company is also 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; Other +1 240 477 3771
Christer Gruvris Brilinta; Diabetes +44 203 749 5711
Nick Stone Respiratory; Renal +44 203 749 5716
US toll free +1 866 381 7277

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