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2019-08-14

AstraZeneca: Lynparza Phase III PAOLA-1 trial met primary endpoint as 1st-line maintenance treatment with bevacizumab for a...

AstraZeneca and MSD's Lynparza, when added to standard-of-care
bevacizumab, significantly increased the time women lived without
disease progression

AstraZeneca and MSD Inc., Kenilworth, N.J., US (MSD: known as Merck &
Co., Inc. inside the US and Canada) today announced positive results
from the Phase III PAOLA-1 trial in women with advanced ovarian
cancer. The trial, in the 1st-line maintenance setting, compared
Lynparza (olaparib) added to standard-of-care (SoC) bevacizumab vs.
bevacizumab alone in women with or without BRCA gene mutations.

The trial met its primary endpoint in the intent-to-treat* population
with a statistically-significant and clinically-meaningful
improvement in progression-free survival (PFS), increasing the time
women taking Lynparza plus bevacizumab lived without disease
progression or death vs. those taking bevacizumab alone. The results,
including biomarker sub-group analyses, will be presented at a
forthcoming medical meeting. The safety and tolerability profiles
observed in PAOLA-1 were generally consistent with those known for
each medicine. PAOLA-1 is the second positive Phase III trial with
Lynparza in 1st-line advanced ovarian cancer.

José Baselga, Executive Vice President, Oncology R&D, said: "The
positive results from the PAOLA-1 trial demonstrate a clear potential
benefit of adding Lynparza to the standard-treatment bevacizumab for
women with advanced ovarian cancer. Following positive results from
the SOLO-1 trial for women with a BRCA gene mutation, the PAOLA-1
trial marks yet another positive Phase III trial for Lynparza as a
1st-line maintenance treatment for women with advanced ovarian
cancer. We look forward to discussing the results with global health
authorities as soon as possible."

Roy Baynes, Senior Vice President and Head of Global Clinical
Development, Chief Medical Officer, MSD Research Laboratories, said:
"The Phase III PAOLA-1 trial demonstrates MSD's and AstraZeneca's
continued commitment to improving clinical outcomes for women with
advanced ovarian cancer. In this co-operative group trial sponsored
by ARCAGY Research, maintenance treatment with Lynparza when added to
a standard-of-care treatment was evaluated in an environment
representative of real clinical practice. By studying Lynparza in
this broader patient population, we have learned more about how it
may help even more patients with advanced ovarian cancer in the
future."

Eric Pujade-Lauraine, Medical Director of ARCAGY Research, said: "The
PAOLA-1 trial is a positive example of the strength and promise of
academia-industry collaboration in advancing science and new
treatment options for patients. We greatly appreciate the commitment
of AstraZeneca and MSD in working with academic cooperative groups in
ENGOT and look forward to sharing the full PAOLA-1 results at a
forthcoming medical meeting."

PAOLA-1 is an ENGOT (European Network of Gynaecological Oncological
Trial groups) trial, sponsored by ARCAGY Research (Association de
Recherche sur les CAncers dont GYnécologiques) on behalf of GINECO
(Groupe d'Investigateurs National des Etudes des Cancers Ovariens et
du sein). ARCAGY-GINECO is an academic group specialising in clinical
and translational research in patients' cancers and a member of the
GCIG (Gynecologic Cancer InterGroup).

About PAOLA-1

PAOLA-1 is a randomised, double-blind Phase III trial testing the
efficacy and safety of Lynparza added to SoC bevacizumab vs.
bevacizumab alone, as a 1st-line maintenance treatment for
newly-diagnosed advanced FIGO Stage III-IV high grade serous or
endometroid ovarian, fallopian tube, or peritoneal cancer patients
who had a complete or partial response to 1st-line treatment with
platinum-based chemotherapy and bevacizumab. The intent-to-treat*
population refers to all patients randomised in the trial.

About ovarian cancer

Ovarian cancer is the eighth most common cause of death from cancer in
women worldwide. In 2018, there were nearly 300,000 new cases
diagnosed and around 185,000 deaths.[1] Most women are diagnosed with
advanced (Stage III or IV) ovarian cancer and have a five-year
survival rate of approximately 30%.[2] For newly-diagnosed advanced
ovarian cancer, the primary aim of treatment is to delay progression
of the disease for as long as possible and maintain the patient's
quality of life with the intent of achieving complete remission or
cure.[3,4,5,6]

About Lynparza

Lynparza is a first-in-class PARP inhibitor and the first targeted
treatment to block DNA damage response (DDR) in cells/tumours
harbouring a deficiency in homologous recombination repair, such as
mutations in BRCA1 and/or BRCA2. Inhibition of PARP with Lynparza
leads to the trapping of PARP bound to DNA single-strand breaks,
stalling of replication forks, their collapse and the generation of
DNA double-strand breaks and cancer cell death. Lynparza is being
tested in a range of PARP-dependent tumour types with defects and
dependencies in the DDR pathway.

Lynparza is currently approved in 64 countries, including those in the
EU, for the maintenance treatment of platinum-sensitive relapsed
ovarian cancer, regardless of BRCA status. It is approved in the US,
the EU, Japan and several other countries as 1st-line maintenance
treatment of BRCA-mutated advanced ovarian cancer following response
to platinum-based chemotherapy. It is also approved in 43 countries,
including the US and Japan, for germline BRCA-mutated, HER2-negative,
metastatic breast cancer, previously treated with chemotherapy; in
the EU, this includes locally-advanced breast cancer. Regulatory
reviews are underway in other jurisdictions for ovarian, breast and
pancreatic cancers.

Lynparza, which is being jointly developed and commercialised by
AstraZeneca and MSD, is approved for the treatment of advanced
ovarian cancer and metastatic breast cancer and has been used to
treat over 25,000 patients worldwide. Lynparza has the broadest and
most advanced clinical-trial development programme of any PARP
inhibitor, and AstraZeneca and MSD are working together to understand
how it may affect multiple PARP-dependent tumours as a monotherapy
and in combination across multiple cancer types. Lynparza is the
foundation of AstraZeneca's industry-leading portfolio of potential
new medicines targeting DDR mechanisms in cancer cells.

About GINECO

GINECO (Groupe d'Investigateurs National des Etudes des Cancers
Ovariens et du sein) is the French Cooperative Group in Oncology
labelled by INCA (Institut National du Cancer, or French NCI)
developing and conducting gynaecological and metastatic breast cancer
clinical trials at the national and international level. Founded in
1993, the GINECO group is a member of international consortia such as
ENGOT and GCIG.

About ENGOT

ENGOT (European Network for Gynaecological Oncological Trial groups)
is a research network of the European Society of Gynaecological
Oncology (ESGO). Founded in 2007, ENGOT includes 21 cooperative
groups from 25 European countries.

About GCIG

The GCIG (Gynecological Cancer InterGroup) aims to promote and
facilitate high quality clinical trials in order to improve outcomes
for women with gynaecological cancer. Founded in 1998, GCIG includes
23 cooperative groups from 28 countries worldwide.

About the AstraZeneca and MSD strategic oncology collaboration

In July 2017, AstraZeneca and Merck & Co., Inc., Kenilworth, NJ, US,
known as MSD outside the US and Canada, announced a global strategic
oncology collaboration to co-develop and co-commercialise Lynparza,
the world's first PARP inhibitor, and potential new medicine
selumetinib, a MEK inhibitor, for multiple cancer types. Working
together, the companies will develop Lynparza and selumetinib in
combination with other potential new medicines and as monotherapies.
Independently, the companies will develop Lynparza and selumetinib in
combination with their respective PD-L1 and PD-1 medicines.

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, the Company is
committed to advance oncology as a key growth driver for AstraZeneca
focused on lung, ovarian, breast and blood cancers. In addition to
AstraZeneca's main capabilities, the Company is actively pursuing
innovative partnerships and investment that accelerate the delivery
of our strategy, as illustrated by the 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 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, CVRM and Respiratory. AstraZeneca
operates in over 100 countries and its innovative medicines are used
by millions of patients worldwide. For more information, please visit
astrazeneca.com (http://www.astrazeneca.com/) and follow us on
Twitter @AstraZeneca (https://twitter.com/AstraZeneca).

Media Relations
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Matt Kent BioPharmaceuticals +44 203 749 5906
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Michele Meixell US +1 302 885 2677

Investor
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Larsen
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