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 March 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 granted
orphan drug designation in Japan for BRCA-mutated metastatic
pancreatic cancer
19 March 2020 07:00 GMT
Lynparza granted
orphan drug designation in Japan
for BRCA-mutated metastatic pancreatic cancer
Designation based on the Phase III POLO trial that showed Lynparza
nearly
doubled the time patients lived without disease progression vs.
placebo
AstraZeneca today announced that Lynparza (olaparib) has been granted orphan drug
designation (ODD) in Japan for the maintenance treatment of
germline BRCA-mutated (gBRCAm) curatively unresectable pancreatic
cancer. Lynparza is co-developed and co-commercialised with
MSD Inc., Kenilworth, N.J., US (MSD: known as Merck & Co., Inc.
inside the US and Canada).
The Japanese Ministry of Health, Labour and Welfare grants ODD to
medicines intended for the treatment of diseases that affect fewer
than 50,000 patients in Japan and for which there is a high unmet
medical need.
Pancreatic cancer has the lowest survival rate of the most common
cancers and is the only major cancer with a five-year survival rate
below 10% in almost every country.
José Baselga, Executive Vice President, R&D Oncology,
said: "Japan has the fifth-highest incidence of pancreatic cancer
worldwide and patients have seen limited treatment advances over
the last few decades. This designation is an important step forward
in bringing the first targeted medicine to biomarker-selected
patients with advanced pancreatic cancer in Japan."
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 trial demonstrated that treatment
with Lynparza extended time without disease progression or
death in patients with germline BRCA-mutated metastatic pancreatic
cancer and we are hopeful that we will be able to bring this
treatment to patients in Japan soon."
The Phase III POLO
trial showed 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 in line with that
observed in previous trials.
Lynparza was approved in
the US as a 1st-line maintenance treatment for patients with gBRCAm
metastatic pancreatic cancer in December
2019 with ongoing
regulatory reviews in the EU and other
jurisdictions.
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 Japan
has the fifth-highest rate of pancreatic cancer in the world with
43,000 new cases diagnosed in 2018.2,3 Pancreatic
cancer is the fourth leading cause of cancer death in Japan,
resulting in 37,000 deaths in 2018.3
Globally, pancreatic cancer is the 11th-most commonly occurring
cancer and
the seventh leading cause of cancer death.4,5 There
were approximately 460,000 new cases worldwide in
2018.5 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.6,7 Around
80% of pancreatic cancer patients are diagnosed when the disease
has metastasised, at which point average survival is less than a
year.8 Despite
advances in treatment, few improvements have been made in diagnosis
and treatment in the past few decades.9 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.10
POLO
POLO is a Phase III randomised, double-blind, placebo-controlled,
multi-centre trial of Lynparza tablets (300mg twice daily) as maintenance
monotherapy versus 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 (OS), time to second
disease progression, overall response rate and health-related
quality of life.
The results showed a statistically significant and clinically
meaningful improvement in PFS, where 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 and
reduced the risk of disease progression or death by 47% (HR 0.53
[95% confidence interval (CI), 0.35-0.82], p=0.004). In patients
with measurable disease at baseline, 23% responded
to Lynparza versus 12% on placebo (odds ratio, 2.30 [95%
CI, 0.89-6.76]) and had a median duration of treatment in excess of
two years (24.9 months [95% CI, 14.8-could not be calculated])
versus 3.7 months on placebo (95% CI, 2.10-could not be
calculated). The median OS, a secondary endpoint, at interim
analysis and at a data maturity of 46% was 18.9 months
for Lynparza versus 18.1 months for placebo but did not
reach statistical significance (HR=0.91;
p=0.68).
The safety and tolerability profile of Lynparza in the POLO trial was in line with that
observed in previous trials.
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, 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. In 2019, Lynparza was additionally approved
in the US for the treatment of germline BRCA-mutated metastatic
pancreatic 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 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.
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 and Metabolism, and Respiratory. 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.
Media
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References
1. Pancreaticcancer.org.uk. Pancreatic cancer statistics. Available
at: www.pancreaticcancer.org.uk/statistics/ [Accessed
March 2020].
2. World Cancer Research Fund International. Pancreatic cancer
statistics. Available at: www.wcrf.org/dietandcancer/cancer-trends/pancreatic-cancer-statistics [Accessed
March 2020].
3. World Health Organization. IARC. (2018). Japan. Globocan 2018.
Available at: https://gco.iarc.fr/today/data/factsheets/populations/392-japan-fact-sheets.pdf [Accessed
March 2020].
4. 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.
5. World Health Organization. IARC. (2019). Estimated number of
deaths in 2018, worldwide, both sexes, all ages. Website
available here.
[Accessed March 2020].
6. 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].
7. DaVee (2018). Pancreatic cancer screening in high-risk
individuals with germline genetic
mutations. Gastrointestinal
Endoscopy. 87(6),
pp.1443-1450.
8. 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.
9. Sheahan et al. (2018). Targeted therapies in the management of
locally advanced and metastatic pancreatic cancer: a systematic
review. Oncotarget. 9(30): 21613-21627.
10. 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:
19 March
2020
|
By: /s/
Adrian Kemp
|
|
Name:
Adrian Kemp
|
|
Title:
Company Secretary
|