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 March
2019
Commission
File Number: 001-11960
AstraZeneca PLC
1
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United
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
Lynparza
receives positive EU CHMP opinion
1 March 2019 13:45 GMT
Lynparza receives positive EU CHMP opinion for
use in
germline BRCA-mutated HER2-negative advanced breast
cancer
AstraZeneca and MSD, Inc., Kenilworth, NJ, US (MSD: known as Merck
& Co., Inc. inside the US and Canada) today announced that
the Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency has adopted a positive opinion,
recommending the use of Lynparza (olaparib) tablets as monotherapy for the
treatment of adult patients with germline BRCA1/2-mutations, who have human epidermal growth
factor receptor 2 (HER2)-negative locally advanced or metastatic
breast cancer.
Patients should have previously been treated with an anthracycline
and a taxane in the (neo)adjuvant or metastatic setting unless
patients were not suitable 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:
"Despite progress in treating patients with advanced breast cancer,
there remains a significant unmet need for new treatment options.
If approved, Lynparza will provide these patients with both a
targeted and oral chemotherapy-free option. We now have evidence
supporting the potential use of Lynparza in patients with BRCA-mutated breast, ovarian and pancreatic cancers,
which demonstrates our ongoing commitment to improving patient
outcomes in difficult-to-treat cancers."
Roy Baynes, Senior Vice President and Head of Global Clinical
Development, Chief Medical Officer, Merck Research Laboratories,
said: "The positive opinion from CHMP for Lynparza in this patient population is an important
milestone. This decision brings us one step closer to offering a
new treatment option to patients with advanced breast cancer and
further underscores the critical need to identify
patients' BRCA status, in addition to hormone receptor and
HER2 expression status, as part of the management of this
disease."
The positive opinion is based on data from the randomised,
open-label, Phase III OlympiAD trial, which
tested Lynparza against the physician's choice of
chemotherapy.
Lynparza is currently
approved in over 60 countries including those in the EU for the
maintenance treatment of platinum-sensitive relapsed ovarian cancer
regardless of BRCAstatus. It is approved in the US for 1st-line
maintenance therapy in BRCAm advanced ovarian cancer following response to
platinum-based chemotherapy. It is also approved in several
countries, including the US and Japan, for
germline BRCAm HER2-negative metastatic breast cancer
previously treated with chemotherapy; regulatory reviews are
underway in other jurisdictions.
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 Lynparza and 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).
In the trial, Lynparza provided patients with a 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 59.9%, which was double the response rate for those in the
chemotherapy arm (ORR 29%). Data from the OlympiAD trial can be
found in the 10 August 2017 issue of the New
England Journal of Medicine.
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 mutations
Breast cancer susceptibility gene 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
germline BRCAm 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 visit
astrazeneca.com and
follow us on Twitter @AstraZeneca.
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Adrian Kemp
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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:
01 March
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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