Blueprint
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 April
2019
Commission
File Number: 001-11960
AstraZeneca PLC
1
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
Lynparza approved in EU for the
treatment of germline BRCA-mutated HER2-negative advanced breast
cancer
10
April 2019 07:00 BST
Lynparza approved in EU for the treatment
of
germline BRCA-mutated HER2-negative advanced breast
cancer
AstraZeneca and MSD's Lynparza reduced the risk of
disease
progression or death by 42% vs. chemotherapy in Phase III OlympiAD
trial
First PARP inhibitor approved in the EU for patients with
this
difficult-to-treat disease and third EU approval for
Lynparza
AstraZeneca and MSD Inc., Kenilworth, N.J., US (MSD: known as Merck
& Co., Inc. inside the US and Canada) today announced the
European Commission has approved Lynparza (olaparib) as a monotherapy for the
treatment of adult patients with
germline BRCA1/2-mutations (gBRCAm), and who have human epidermal
growth factor receptor 2 (HER2)-negative locally-advanced or
metastatic breast cancer.
Under
the licensed indication, patients should have previously been
treated with an anthracycline and a taxane in the (neo)adjuvant or
metastatic setting unless they were unsuitable 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: "With
this approval, Lynparza provides patients throughout the EU with a
targeted and oral chemotherapy-free treatment option for a
difficult-to-treat cancer. It also reinforces the importance of
testing for biomarkers including BRCA, hormone receptor and HER2 expression, helping
physicians to make the most informed treatment decisions for
patients."
Roy Baynes, Senior Vice President and Head of Global Clinical
Development, Chief Medical Officer, MSD Research Laboratories,
said: "In the OlympiAD trial, which supported this
approval, Lynparza demonstrated a meaningful improvement in
progression-free survival compared to chemotherapy in patients with
germline BRCA-mutated metastatic breast cancer. We look forward
to making this new option available across the EU, where we hope it
will improve outcomes for many patients."
The approval was based on data from the randomised, open-label,
Phase III OlympiAD trial which tested Lynparza vs. physician's choice of chemotherapy
(capecitabine, eribulin, or vinorelbine). In the
trial, Lynparzaprovided patients with a statistically-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 52%, which was double the ORR for those in the chemotherapy arm
(23%).
This is the third indication for Lynparza in the EU, and AstraZeneca and MSD are
working together to deliver Lynparza as quickly as possible to more patients
across multiple settings. Lynparza has a broad clinical development programme,
including the ongoing Phase III OlympiA which is
testing Lynparza as an adjuvant treatment in patients with
gBRCAm HER2-negative breast cancer.
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 Lynparzaand 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).
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
Breast cancer susceptibility genes 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 that Lynparza became
the first PARP inhibitor to demonstrate benefit in
gBRCAm 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
visitastrazeneca.com and
follow us on Twitter @AstraZeneca.
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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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+1 301 518 4122
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Matt
Kent
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BioPharma
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+44 203 749 5906
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Jennifer
Hursit
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Other
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+44 203 749 5762
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Christina
Malmberg 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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BioPharma (cardiovascular, metabolism)
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+44 203 749 5711
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Nick
Stone
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BioPharma (respiratory, renal)
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+44 203 749 5716
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Josie
Afolabi
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Other medicines
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+44 203 749 5631
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Craig
Marks
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Finance, fixed income
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Kretzmann
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+44 203 749 5824
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US
toll-free
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+1 866 381 72 77
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Adrian Kemp
Company Secretary
AstraZeneca PLC
References
1. International Agency for Research on
Cancer. Breast-fact-sheet. Available
at http://gco.iarc.fr/today/data/factsheets/cancers/20-Breast-fact-sheet.pdf.
Last accessed February 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:
10 April
2019
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By: /s/
Adrian Kemp
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Name:
Adrian Kemp
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Title:
Company Secretary
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