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2018-12-19

AstraZeneca: Lynparza approved by US FDA for 1st-line maintenance therapy in BRCA-mutated advanced ovarian cancer

AstraZeneca and MSD's Lynparza reduced the risk of disease progression
or death by 70% compared to placebo following response to
platinum-based chemotherapy

First PARP inhibitor approved in 1st-line maintenance for BRCAm
advanced ovarian cancer

AstraZeneca and Merck & Co., Inc., Kenilworth, N.J., US (Merck: known
as MSD outside the US and Canada) today announced that the US Food
and Drug Administration (FDA) has approved Lynparza for the
maintenance treatment of adult patients with deleterious or suspected
deleterious germline or somatic BRCA-mutated (gBRCAm or sBRCAm)
advanced epithelial ovarian, fallopian tube or primary peritoneal
cancer who are in complete or partial response to first-line
platinum-based chemotherapy, as detected by an FDA-approved companion
diagnostic test.

This is the first regulatory approval for a PARP inhibitor in the
1st-line maintenance setting for BRCAm advanced ovarian cancer. The
approval was based on positive results from the pivotal Phase III
SOLO-1 trial
(https://www.astrazeneca.com/media-centre/press-releases/2018/solo-1-phas...)
in which Lynparza reduced the risk of disease progression or death by
70 percent in patients with BRCAm advanced ovarian cancer who were in
complete or partial response to platinum-based chemotherapy (HR 0.30
[95% CI 0.23-0.41], p<0.0001) compared to placebo following
platinum-based chemotherapy. The safety profile of Lynparza was
consistent with previous trials.

Dave Fredrickson, Executive Vice President, Head of the Oncology
Business Unit, AstraZeneca, said: "Women with ovarian cancer are
often first diagnosed with advanced disease, which is associated with
poor outcomes. In SOLO-1, Lynparza in the first-line maintenance
setting reduced the risk of disease progression or death by 70
percent for patients with BRCAm advanced ovarian cancer. Today's
approval is a critical advancement and brings us closer to our goal
of helping these patients achieve long-term remission."

Roy Baynes, Senior Vice President and Head of Global Clinical
Development, Chief Medical Officer, MSD Research Laboratories, said:
"The expanded approval of Lynparza based upon the SOLO-1 trial has
the potential to change medical practice and reinforces the
importance of knowing a woman's BRCA status at diagnosis. We continue
to work in collaboration with AstraZeneca on our overall goal of
improving outcomes for patients."

In the SOLO-1 trial, with median 41 months of follow-up, the median
progression-free survival (PFS) for patients treated with Lynparza
was not reached compared to 13.8 months for patients treated with
placebo. Sixty percent of patients receiving Lynparza remained
progression-free at three years compared to 27 percent of patients
receiving placebo. The data from the SOLO-1 trial can be found in the
21 October 2018 online issue of the New England Journal of Medicine
(https://www.nejm.org/doi/full/10.1056/NEJMoa1810858).

Kathleen Moore, co-principal investigator of the SOLO-1 trial and
Associate Director for Clinical Research, Stephenson Cancer Center at
The University of Oklahoma, Oklahoma City, Oklahoma, said: "SOLO-1 is
truly a landmark trial in gynecologic cancer. This approval will
likely change the way we treat women with BRCA-mutated advanced
ovarian cancer. The ability to offer this important first-line
maintenance treatment option to eligible patients may slow down or
even stop the natural course of disease progression."

AstraZeneca and MSD are exploring additional trials in advanced
ovarian cancer, including the ongoing GINECO/ENGOTov25 Phase III
trial, PAOLA-1. This trial is testing the effect of Lynparza in
combination with bevacizumab as a maintenance treatment for patients
with newly-diagnosed advanced ovarian cancer, regardless of their
BRCA status. Results are expected during the second half of 2019.

Financial considerations

Under the oncology collaboration with MSD and following this new
approval for Lynparza, AstraZeneca will receive $70 million as
Ongoing Externalisation Revenue.

About SOLO-1

SOLO-1 is a Phase III randomised, double-blinded, placebo-controlled,
multicentre trial to evaluate the efficacy and safety of Lynparza
tablets (300mg twice daily) as maintenance monotherapy compared with
placebo, in patients with BRCAm advanced ovarian cancer following
1st-line platinum-based chemotherapy. The trial randomised 391
patients with a deleterious or suspected deleterious germline or
somatic BRCA1 or BRCA2 mutation who were in clinical complete or
partial response following platinum-based chemotherapy. Patients were
randomized (2:1) to receive Lynparza or placebo for up to two years
or until disease progression. Patients who had a partial response at
two years were permitted to stay on therapy at the investigator's
discretion. The primary endpoint was PFS and key secondary endpoints
included time to second disease progression or death, time to first
subsequent treatment and overall survival.

About Lynparza

Lynparza is a first-in-class PARP inhibitor and the first targeted
treatment to potentially exploit DNA damage response (DDR) pathway
deficiencies, such as BRCA mutations, to preferentially kill cancer
cells. 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 tumour
types with defects and dependencies in the DDR.

Lynparza, which is being jointly developed and commercialised by
AstraZeneca and MSD, is approved for advanced ovarian cancer and
metastatic breast cancer and has been used in over 20,000 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 ovarian cancer

Ovarian cancer is a leading cause of cancer death in women worldwide,
with a five-year survival rate of 19%.[i]
(http://file:///C:/Users/kdzn235/AppData/Local/Microsoft/Windows/INetCach...)
In 2018, there were over 295,000 new cases diagnosed and around
185,000 deaths.[ii]
(http://file:///C:/Users/kdzn235/AppData/Local/Microsoft/Windows/INetCach...)
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.[iii]
(http://file:///C:/Users/kdzn235/AppData/Local/Microsoft/Windows/INetCach...),[iv]
(http://file:///C:/Users/kdzn235/AppData/Local/Microsoft/Windows/INetCach...),[v]
(http://file:///C:/Users/kdzn235/AppData/Local/Microsoft/Windows/INetCach...),[vi]
(http://file:///C:/Users/kdzn235/AppData/Local/Microsoft/Windows/INetCach...)

About BRCA mutations

BRCA1 and BRCA2 are human genes that produce proteins responsible for
repairing damaged DNA and play an important role in maintaining the
genetic stability of cells. When either of these genes is mutated, or
altered, such that its protein product either is not made or does not
function correctly, DNA damage may not be repaired properly, and
cells become unstable. As a result, cells are more likely to develop
additional genetic alterations that can lead to cancer.

About the AstraZeneca and MSD strategic oncology collaboration

In July 2017, AstraZeneca and Merck & Co., Inc., Kenilworth, NJ, US,
known as MSD outside the United States 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, we are
committed to advance Oncology as a key 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 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 www.astrazeneca.com and follow us on
Twitter @AstraZeneca.

Media Relations
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
Jennifer Hursit UK/Global +44 203 749 5762
Jacob Lund Sweden +46 8 553 260 20
Michele Meixell US +1 302 885 2677

Investor Relations
Thomas Kudsk Larsen +44 203 749 5712
Henry Wheeler Oncology +44 203 749...

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