a5013o
FORM 6-K
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
Report
of Foreign Issuer
Pursuant
to Rule 13a-16 or 15d-16 of
the
Securities Exchange Act of 1934
For the
month of June
2020
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
Lynparza recommended for approval in EU by CHMP for
BRCA-mutated metastatic pancreatic cancer
1 June 2020 07:00 BST
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.
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 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 for patients with
homologous recombination repair (HRR) gene-mutated metastatic
castration-resistant prostate cancer. It
was also approved in the
US 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 of new 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
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.
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 and
follow the Company on Twitter @AstraZeneca.
Contacts
For details on how to contact the Investor Relations Team, please
click here.
For Media contacts, click here.
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.
3. World Health
Organization. IARC. (2019). Estimated number of deaths in 2018,
worldwide, both sexes, all ages. Website
available here.
[Accessed March 2020].
4. Signs and
symptoms of pancreatic cancer. Available
at: www.pancreaticcancer.org.uk/information-and-support/facts-about-pancreatic-cancer/signs-and-symptoms-of-pancreatic-cancer/ [Accessed
March 2020].
5. DaVee (2018). Pancreatic
cancer screening in high-risk individuals with germline genetic
mutations. Gastrointestinal
Endoscopy. 87(6),
pp.1443-1450.
6. Azar et al. (2019). Treatment
and survival rates of stage IV pancreatic cancer at VA hospitals: a
nation-wide study. Journal of Gastrointestinal
Oncology, 10(4),
pp.703-711.
7. Sheahan et al. (2018).
Targeted therapies in the management of locally advanced and
metastatic pancreatic cancer: a systematic
review. Oncotarget. 9(30): 21613-21627.
8. Stunt, A.
(2016). Pancreatic cancer: GPs can help prognosis by identifying
early signs. Guidelines in Practice. Available
at: www.guidelinesinpractice.co.uk/cancer/pancreatic-cancer-gps-can-help-prognosis-by-identifying-early-signs/352855.article [Accessed
March 2020].
Adrian Kemp
Company Secretary
AstraZeneca PLC
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorized.
Date:
01 June 2020
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By: /s/
Adrian Kemp
|
|
Name:
Adrian Kemp
|
|
Title:
Company Secretary
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