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2020-06-01

AstraZeneca: Lynparza recommended for approval in EU by CHMP for BRCA-mutated metastatic pancreatic cancer

Only PARP inhibitor to demonstrate patient benefit in a Phase III
trial in this setting

AstraZeneca and MSD Inc., Kenilworth, N.J., US (MSD: known as Merck &
Co., Inc. inside the US and Canada) today announced that Lynparza
(olaparib) has been recommended for marketing authorisation in the
European Union (EU) for the 1st-line maintenance treatment of
patients with germline BRCA-mutated (gBRCAm) metastatic pancreatic
cancer.

The Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency (EMA) based its positive opinion on results
from the Phase III POLO trial, which were published in The New
England Journal of Medicine
(https://www.nejm.org/doi/full/10.1056/NEJMoa1903387).

The trial demonstrated that Lynparza nearly doubled the time patients
with gBRCAm metastatic pancreatic cancer lived without disease
progression or death to a median of 7.4 months versus 3.8 months on
placebo. The safety and tolerability profile of Lynparza in the POLO
trial was consistent with previous trials.

José Baselga, Executive Vice President, Oncology R&D, said: "Patients
with advanced pancreatic cancer have seen limited treatment advances
over the last few decades. We are now one step closer to bringing the
first targeted medicine to certain biomarker-selected patients with
advanced pancreatic cancer in the EU."

Roy Baynes, Senior Vice President and Head of Global Clinical
Development, Chief Medical Officer, MSD Research Laboratories, said:
"A pancreatic cancer diagnosis is devastating, and we are committed
to research that aims to change the prognosis for patients. The POLO
Phase III trial demonstrated that treatment with Lynparza extended
time without disease progression in certain patients with advanced
pancreatic cancer - we are hopeful that we will be able to bring this
treatment to patients in the EU soon."

The CHMP recommendation is for maintenance treatment with Lynparza for
adult patients with germline BRCA1/2 mutations who have metastatic
adenocarcinoma of the pancreas and have not progressed after a
minimum of 16 weeks of platinum treatment within a 1st-line
chemotherapy regimen.

Lynparza is approved in the US
(https://www.astrazeneca.com/media-centre/press-releases/2019/lynparza-ap...)
and several other countries as a 1st-line maintenance treatment for
patients with gBRCAm metastatic pancreatic cancer based on the Phase
III POLO trial, with ongoing regulatory reviews in the EU and other
jurisdictions.

Lynparza was recently approved in the US
(https://www.astrazeneca.com/media-centre/press-releases/2020/lynparza-ap...)
for patients with homologous recombination repair (HRR) gene-mutated
metastatic castration-resistant prostate cancer. It was also approved
in the US
(https://www.astrazeneca.com/media-centre/press-releases/2020/tlynparza-a...)
as a 1st-line maintenance treatment with bevacizumab for patients
with homologous recombination deficiency (HRD)-positive advanced
ovarian cancer.

Pancreatic cancer

Pancreatic cancer is a deadly cancer with a high unmet medical need.
The disease has the lowest survival rate of the most common
cancers.[1] Globally, pancreatic cancer is the 11th-most commonly
occurring cancer and the seventh leading cause of cancer death.[2,3]
There were approximately 460,000 new cases worldwide in 2018.[3] As
there are often no symptoms, or symptoms may be non-specific in the
early stages, it is most commonly diagnosed at an incurable
stage.[4,5]

Around 80% of pancreatic cancer patients are diagnosed when the
disease has metastasised, at which point average survival is less
than a year.[6] Despite advances in treatment, few improvements have
been made in diagnosis and treatment in the past few decades.[7]
Current treatment is surgery (for which approximately only 10-20% of
patients are eligible), chemotherapy and radiotherapy, highlighting a
critical unmet medical need for more effective treatment options.[8]

POLO

POLO is a Phase III randomised, double-blinded, placebo-controlled,
multi-centre trial of Lynparza tablets (300mg twice daily) as
maintenance monotherapy vs. placebo. The trial randomised 154
patients with gBRCAm metastatic pancreatic cancer whose disease had
not progressed on 1st-line platinum-based chemotherapy. Patients were
randomised (3:2) to receive Lynparza or placebo until disease
progression. The primary endpoint was progression-free survival (PFS)
and key secondary endpoints included overall survival, time to second
disease progression, overall response rate and health-related quality
of life.

BRCA mutations

BRCA1 and BRCA2 (breast cancer susceptibility genes 1/2) 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.

Lynparza

Lynparza (olaparib) 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 a number of countries, including
those in the EU, for the maintenance treatment of platinum-sensitive
relapsed ovarian cancer. It is approved in the US, the EU, Japan,
China, 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 the US as a
1st-line maintenance treatment with bevacizumab for patients with
homologous recombination deficiency (HRD)-positive advanced ovarian
cancer. Lynparza is approved in the US, Japan, and a number of other
countries for germline BRCA-mutated, HER2-negative, metastatic breast
cancer, previously treated with chemotherapy; in the EU, this
includes locally advanced breast cancer. It is also approved in the
US and several other countries for the treatment of germline
BRCA-mutated metastatic pancreatic cancer. Lynparza is approved in
the US for homologous recombination repair (HRR) gene-mutated
metastatic castration-resistant prostate cancer. Regulatory reviews
are underway in several jurisdictions for ovarian, breast, pancreatic
and prostate cancers.

Lynparza, which is being jointly developed and commercialised by
AstraZeneca and MSD, has been used to treat over 30,000 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.

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 Koselugo (selumetinib), a MEK
inhibitor, for multiple cancer types. Working together, the companies
will develop Lynparza and Koselugo in combination with other
potential new medicines and as monotherapies. Independently, the
companies will develop Lynparza and Koselugo in combination with
their respective PD-L1 and PD-1 medicines.

AstraZeneca in oncology

AstraZeneca has a deep-rooted heritage in oncology and offers a
quickly growing portfolio ofnew medicines that has the potential to
transform patients' lives and the Company's future. With six new
medicines launched between 2014 and 2020, and a broad pipelineof
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.

AstraZeneca

AstraZeneca (LSE/STO/NYSE: AZN) 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 & Immunology.
Based in Cambridge, UK, AstraZeneca operates in over 100 countries
and its innovative medicines are used by millions of patients
worldwide. Please visit astrazeneca.com (http://www.astrazeneca.com/)
and follow the Company on Twitter @AstraZeneca
(https://twitter.com/AstraZeneca).

Contacts

For details on how to contact the Investor Relations Team, please
click here
(https://www.astrazeneca.com/investor-relations.html#Contacts). For
Media contacts, click here
(https://www.astrazeneca.com/media-centre/contacts.html).

References

1. Pancreaticcancer.org.uk. Pancreatic cancer statistics. Available
at: www.pancreaticcancer.org.uk/statistics/ [Accessed March 2020].

2. Bray et al. Global cancer statistics 2018: GLOBOCAN estimates of
incidence and mortality worldwide for 36 cancers in 185 countries.
World Journal of Oncology. 2018;68(6):394-424. doi:
10.3322/caac.21492.

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