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 August
2019
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
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82-_____________
AstraZeneca PLC
INDEX
TO EXHIBITS
1.
Lynparza
Phase III PROfound trial in HRR*
07 August 2019 07:00 BST
Lynparza Phase
III PROfound trial in HRR* mutation-selected metastatic
castration-resistant prostate cancer met primary
endpoint
AstraZeneca and MSD's Lynparza met the primary endpoint of
significantly increasing the time patients selected for BRCA1/2 or
ATM mutations live without radiographic disease progression vs.
standard of care treatment
Only PARP inhibitor with positive Phase III results in four
different cancer types (ovarian, breast, pancreatic and
prostate)
AstraZeneca and MSD Inc., Kenilworth, N.J., US (MSD: known as Merck
& Co., Inc. inside the US and Canada) today announced positive
results from the Phase III PROfound trial
of Lynparza(olaparib) in men with metastatic
castration-resistant prostate cancer (mCRPC) who have a *homologous
recombination repair gene mutation (HRRm) and
have progressed on prior treatment with new hormonal anticancer
treatments (e.g. enzalutamide and abiraterone).
Results from the trial showed a statistically-significant and
clinically-meaningful improvement in the primary endpoint of
radiographic progression-free survival (rPFS)
with Lynparza vs. enzalutamide or abiraterone in men with
mCRPC selected for BRCA1/2 or ATM gene mutations, a subpopulation
of HRR gene mutations. The safety and tolerability profile
of Lynparza was generally consistent with previous
trials.
José Baselga, Executive Vice President, Oncology R&D,
said: "For men with metastatic castration-resistant prostate cancer
the disease remains deadly, especially in those who have failed on
a new hormonal anticancer treatment. This trial is the only
positive Phase III trial of any PARP inhibitor in metastatic
castration-resistant prostate cancer, where the need
for new, effective therapies is high.
The PROfound trial also demonstrates the potential value of genomic
testing in this at-risk patient population. We look forward to
discussing these results with global health authorities
soon."
Roy Baynes, Senior Vice President and Head of Global Clinical
Development, Chief Medical Officer, MSD Research Laboratories,
said: "Metastatic castration-resistant prostate cancer is a deadly
disease and represents an area of critical unmet medical need. The
Phase III PROfound trial is another example of MSD and
AstraZeneca's shared commitment to improving long-term outcomes for
people living with cancer. These results represent the potential
for a new, oral targeted treatment option for this patient
population."
AstraZeneca and MSD plan to present the full data from the trial at
a forthcoming medical meeting. The companies are also exploring
additional trials in prostate cancer, including the ongoing Phase
III PROpel trial, testing Lynparza as a 1st-line therapy in mCRPC, in
combination with abiraterone.
About PROfound
PROfound
is a prospective,
multicentre, randomised, open-label, Phase III trial testing the
efficacy and safety of Lynparza versus
enzalutamide or abiraterone in patients with mCRPC who have
progressed on prior treatment with new hormonal anticancer treatments and
have a qualifying tumour mutation in one of 15 genes involved in
the HRR pathway, including among them BRCA1/2, ATM and
CDK12.
About metastatic castration-resistant prostate cancer
Prostate cancer is the
second-most common cancer in men, with an estimated 1.3 million new
cases diagnosed worldwide in 2018 and is associated with a
significant mortality rate.1Development
of prostate cancer is often driven by male sex hormones called
androgens, including testosterone.2 mCRPC
occurs when prostate cancer grows and spreads to other parts of the
body despite the use of androgen-deprivation therapy to block the
action of male sex hormones.2 Approximately
10-20% of men with advanced prostate cancer will develop CRPC
within five years, and at least 84% of these will have metastases
at the time of CRPC diagnosis.3Of
men with no metastases at CRPC diagnosis, 33% are likely to develop
metastases within two years.3 Despite
an increase in the number of available therapies for men with
mCRPC, five-year survival remains low.3
About 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 (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 PARP-dependent tumour types with defects
and dependencies in the DDR pathway.
Lynparza is currently
approved in 64 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, EU, Japan and several
other countries as 1st-line
maintenance treatment of BRCAm advanced ovarian cancer following
response to platinum-based chemotherapy. It is also approved in 40
countries, including the US and Japan, for germline BRCAm
HER2-negative metastatic breast cancer previously treated with
chemotherapy; in the EU this includes locally advanced breast
cancer. Regulatory reviews are underway in other jurisdictions for
ovarian, breast and pancreatic cancers.
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 25,000 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.
In
January 2016, AstraZeneca
announced that Lynparza was
granted Breakthrough Therapy Designation by the US Food and Drug
Administration (FDA) for the monotherapy treatment of BRCA1/2- or
ATM gene-mutated mCRPC in patients who have received a prior
taxane-based chemotherapy and at least one newer hormonal agent
(abiraterone or enzalutamide), based on the positive results of the
TOPARP-A Phase II trial.
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 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, CVRM 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 and
follow us on Twitter @AstraZeneca.
Media
Relations
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Gonzalo
Viña
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+44 203
749 5916
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Rob
Skelding
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Oncology
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+44 203
749 5821
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Rebecca
Einhorn
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Oncology
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+1 301
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Matt
Kent
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BioPharmaceuticals
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+44 203
749 5906
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Jennifer
Hursit
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Other
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203 749 5762
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Hägerstrand
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Michele
Meixell
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US
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+1 302
885 2677
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Investor
Relations
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Thomas
Kudsk Larsen
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+44 203
749 5712
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Henry
Wheeler
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Oncology
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+44 203
749 5797
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Christer
Gruvris
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BioPharmaceuticals
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Nick
Stone
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+44 203
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Afolabi
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Other
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+44 203
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Adrian Kemp
Company Secretary
AstraZeneca PLC
References
1. World
Health Organisation. International Agency for Research on Cancer.
Global Cancer Statistics 2018 estimates of incidence and mortality
worldwide for 36 cancers in 185 countries https://gco.iarc.fr/[Accessed
July 2019].
2. Cancer.Net. (2019). Treatment of metastatic castration-resistant
prostate cancer.
https://www.cancer.net/research-and-advocacy/asco-care-and-treatment-recommendations-patients/treatment-metastatic-castration-resistant-prostate-cancer [Accessed
July 2019].
3. Cancer.Net. (2019). Prostate Cancer - Statistics. Available
at: www.cancer.net/cancer-types/prostate-cancer/statistics [Accessed
July 2019].
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:
7 August
2019
|
By: /s/
Adrian Kemp
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Name:
Adrian Kemp
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Title:
Company Secretary
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