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2017-10-31

AstraZeneca: AstraZeneca and Incyte enter clinical trial collaboration in early lung cancer

AstraZeneca and Incyte enter clinical trial collaboration in early
lung cancer

AstraZeneca and MedImmune, its global biologics research and
development arm, today announced the expansion of their clinical
collaboration with Incyte Corporation. As part of the agreement, the
companies will evaluate the efficacy and safety of epacadostat,
Incyte's investigational selective IDO1 enzyme inhibitor, in
combination with AstraZeneca's Imfinzi (durvalumab), a human
monoclonal antibody directed against PD-L1, compared to Imfinzi
alone.

The exclusive collaboration for the study population allows for the
two companies to conduct a Phase III trial in patients with
locally-advanced (Stage III), unresectable non-small cell lung cancer
(NSCLC) whose disease has not progressed following platinum-based
chemotherapy concurrent with radiation therapy (CRT).

Sean Bohen, Executive Vice President, Global Medicines Development and
Chief Medical Officer at AstraZeneca, said: "Imfinzi has shown
exciting clinical potential in treating patients with locally
advanced lung cancer. We are pleased to build on recent data from the
PACIFIC trial to further explore how Imfinzi, in combination with an
IDO inhibitor could provide additional benefit to patients with
locally-advanced lung cancer."

Steven Stein, MD, Chief Medical Officer, Incyte, said: "We are pleased
to expand our ongoing clinical collaboration with AstraZeneca and to
further explore the potential of epacadostat in patients with
locally-advanced unresectable lung cancer. We look forward to
beginning an additional pivotal trial for epacadostat, as we seek to
position IDO1 enzyme inhibition as a key component of combination
immunotherapy."

The Phase III trial, which will be co-funded by the two companies and
will be conducted by AstraZeneca, is expected to begin enrolling
patients in the first half of 2018. This agreement builds on an
existing clinical collaboration for Imfinzi and epacadostat announced
by both companies in May 2014
(http://phx.corporate-ir.net/phoenix.zhtml?c=69764&p=irol-newsArticle_pri...).

- ENDS -

NOTES TO EDITORS

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.

Stage III lung cancer represents approximately one-third of NSCLC
incidence and was estimated to affect around 105,000 patients in
seven leading markets[1]
(http://file:///C:/Users/kdzn235/AppData/Local/Microsoft/Windows/INetCach...)
in 2016. More than 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 Epacadostat (INCB024360)

The immunosuppressive effects of indoleamine 2,3-dioxygenase 1 (IDO1)
enzyme activity on the tumour microenvironment help cancer cells
evade immunosurveillance. Epacadostat is an investigational,
highly-potent and selective oral inhibitor of the IDO1 enzyme. In
single-arm studies, the combination of epacadostat and immune
checkpoint inhibitors has shown proof-of-concept in patients with
unresectable or metastatic melanoma, non-small cell lung cancer,
renal cell carcinoma, squamous cell carcinoma of the head and neck
and bladder cancer. In these studies, epacadostat combined with the
CTLA-4 inhibitor ipilimumab or the PD-1 inhibitors pembrolizumab or
nivolumab improved response rates compared with studies of the immune
checkpoint inhibitors alone.

About Imfinzi

Imfinzi (durvalumab), a human monoclonal antibody directed against
PD-L1, blocks PD-L1 interaction with PD-1 on tumour cells and CD80 on
immune 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 and haematological malignancies.

About Incyte

Incyte Corporation is a Wilmington, Delaware-based biopharmaceutical
company focused on the discovery, development and commercialization
of proprietary therapeutics. For additional information on Incyte,
please visit the Company's website at www.incyte.com.

Follow @Incyte on Twitter at https://twitter.com/Incyte.

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 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

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 & 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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[1]
(http://file:///C:/Users/kdzn235/AppData/Local/Microsoft/Windows/INetCach...)
France, Germany, Japan, Italy, Spain, UK, US

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