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2019-03-01

AstraZeneca: Lynparza receives positive EU CHMP opinion for use in germline BRCA-mutated HER2-negative advanced breast cancer

AstraZeneca and MSD, Inc., Kenilworth, NJ, US (MSD: known as Merck &
Co., Inc. inside the US and Canada) today announced that the
Committee for Medicinal Products for Human Use (CHMP) of the European
Medicines Agency has adopted a positive opinion, recommending the use
of Lynparza (olaparib) tablets as monotherapy for the treatment of
adult patients with germline BRCA1/2-mutations, who have human
epidermal growth factor receptor 2 (HER2)-negative locally advanced
or metastatic breast cancer.

Patients should have previously been treated with an anthracycline and
a taxane in the (neo)adjuvant or metastatic setting unless patients
were not suitable for these treatments. Patients with hormone
receptor (HR)-positive breast cancer should also have progressed on
or after prior endocrine therapy, or be considered unsuitable for
endocrine therapy.

Dave Fredrickson, Executive Vice President, Oncology, said: "Despite
progress in treating patients with advanced breast cancer, there
remains a significant unmet need for new treatment options. If
approved, Lynparza will provide these patients with both a targeted
and oral chemotherapy-free option. We now have evidence supporting
the potential use of Lynparza in patients with BRCA-mutated breast,
ovarian and pancreatic cancers, which demonstrates our ongoing
commitment to improving patient outcomes in difficult-to-treat
cancers."

Roy Baynes, Senior Vice President and Head of Global Clinical
Development, Chief Medical Officer, Merck Research Laboratories,
said: "The positive opinion from CHMP for Lynparza in this patient
population is an important milestone. This decision brings us one
step closer to offering a new treatment option to patients with
advanced breast cancer and further underscores the critical need to
identify patients' BRCA status, in addition to hormone receptor and
HER2 expression status, as part of the management of this disease."

The positive opinion is based on data from the randomised, open-label,
Phase III OlympiAD trial, which tested Lynparza against the
physician's choice of chemotherapy.

Lynparza is currently approved in over 60 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
for 1st-line maintenance therapy in BRCAm advanced ovarian cancer
following response to platinum-based chemotherapy. It is also
approved in several countries, including the US and Japan, for
germline BRCAm HER2-negative metastatic breast cancer previously
treated with chemotherapy; regulatory reviews are underway in other
jurisdictions.

About OlympiAD

OlympiAD was a global, randomised, open-label, multi-centre Phase III
trial of 302 patients, assessing the efficacy and safety of Lynparza
tablets (300mg twice daily) compared to the physician's choice of
chemotherapy (capecitabine, eribulin or vinorelbine); 205 patients
were randomised to receive Lynparza and 97 patients were randomised
to receive chemotherapy.

Patients in the OlympiAD trial had germline BRCA1 and/or
BRCA2-mutated, HER2-negative (HR-positive or triple negative) breast
cancer and received Lynparza for treatment in the metastatic setting.
Prior to enrolment, all patients were treated with an anthracycline
(unless it was contraindicated) and a taxane chemotherapy in the
neoadjuvant, adjuvant or metastatic setting. Patients with metastatic
breast cancer (71% of patients) had received no more than two
previous chemotherapy treatments for metastatic disease. Patients
with HR-positive breast cancer had received at least one endocrine
(hormonal) therapy (in the adjuvant or metastatic setting) and had
disease progression during therapy, unless they had disease for which
endocrine therapy was considered inappropriate. Previous treatment
with platinum chemotherapy in the neoadjuvant, adjuvant or metastatic
setting was allowed (28% of patients).

In the trial, Lynparza provided patients with a significant median
progression-free survival improvement of 2.8 months (7.0 months for
Lynparza vs. 4.2 months for chemotherapy). Patients taking Lynparza
experienced an objective response rate (ORR) of 59.9%, which was
double the response rate for those in the chemotherapy arm (ORR 29%).
Data from the OlympiAD trial can be found in the 10 August 2017 issue
of the New England Journal of Medicine
(http://www.nejm.org/doi/full/10.1056/NEJMoa1706450).

The most common adverse reactions (?20%) in the OlympiAD trial of
patients who received Lynparza were nausea (58%), anaemia (40%),
fatigue (including asthenia) (37%), vomiting (30%), neutropenia
(27%), respiratory tract infection (27%), leukopenia (25%), diarrhoea
(21%), and headache (20%). The percentage of patients who
discontinued treatment in the Lynparza arm was 5% vs. 8% in the
chemotherapy arm.

About advanced breast cancer

Advanced/metastatic breast cancer refers to Stage III and IV breast
cancer. Stage III disease may also be referred to as locally-advanced
breast cancer, while metastatic disease is the most-advanced stage of
breast cancer (Stage IV) and occurs when cancer cells have spread
beyond the initial tumour site to other organs of the body outside
the breast. Since there is no cure for the disease, the goal of
current treatment is to delay disease worsening or death.

In 2018, there were an estimated 2.1 million new cases of breast
cancer worldwide - one in four cancer cases among women (24.2%). In
Europe the estimated 5-year prevalence of breast cancer in 2018 was
2,054,887 cases.1 Approximately 30% of women who are diagnosed with
early breast cancer will go on to develop advanced disease.

About BRCA mutations

Breast cancer susceptibility gene 1/2 (BRCA1 and BRCA2) are human
genes that produce proteins responsible for repairing damaged DNA and
play an important role 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 Lynparza

Lynparza (olaparib) is a first-in-class PARP inhibitor and the first
targeted treatment to block DNA damage response in cells/tumours
harbouring a deficiency in homologous recombination repair (HRR),
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 tumour types with defects and
dependencies in the DDR.

Lynparza, which is being jointly developed and commercialised by
AstraZeneca and MSD, is approved for multiple indications in advanced
ovarian cancer and metastatic breast cancer and has been used in over
20,000 patients worldwide. On 26 February 2019, AstraZeneca and MSD
announced
(https://www.astrazeneca.com/media-centre/press-releases/2019/lynparza-si...)
that Lynparza became the first PARP inhibitor to demonstrate benefit
in germline BRCAm metastatic pancreatic cancer in the Phase III POLO
trial.

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 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 a monotherapy.
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 one of AstraZeneca's four 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 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 astrazeneca.com
(http://www.astrazeneca.com/) and follow us on Twitter @AstraZeneca
(https://twitter.com/AstraZeneca).

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