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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 January
2018
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
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United
Kingdom
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82-_____________
12 January 2018 16:10 GMT
LYNPARZA
APPROVED BY US FDA IN GERMLINE
BRCA-MUTATED
METASTATIC BREAST CANCER
Lynparza is the first and only PARP inhibitor approved for use
beyond ovarian cancer
Lynparza reduced the risk of disease progression or death by
42%
compared to standard of care chemotherapy
AstraZeneca and Merck & Co., Inc., Kenilworth, N.J., US (Merck:
known as MSD outside the US and Canada) today announced that the US
Food and Drug Administration (FDA) has approved Lynparza (olaparib), for use in patients with deleterious
or suspected deleterious germline BRCA-mutated (gBRCAm), human epidermal growth factor receptor 2
(HER2)-negative metastatic breast cancer who have been previously
treated with chemotherapy in the neoadjuvant, adjuvant or
metastatic setting. Patients with hormone receptor positive (HR+)
breast cancer should have been treated with a prior endocrine
therapy or be considered inappropriate for endocrine therapy.
Patients are selected for therapy based on an FDA-approved
companion diagnostic from Myriad Genetics.
Dave Fredrickson, Executive Vice President, Head of the Oncology
Business Unit, AstraZeneca, said: "This new approval for
Lynparza
makes it the first and only PARP
inhibitor approved in metastatic breast cancer, and the only PARP
inhibitor approved beyond ovarian cancer. This is significant for
breast cancer patients, as the identification of
BRCA
status, in addition to hormone
receptor and HER2 status, becomes a potentially critical step in
the management of their disease."
Roy Baynes, Senior Vice President and Head of Global Clinical
Development, Chief Medical Officer, Merck Research Laboratories
said: "This additional approval for Lynparza represents an important advance for women with
HER2-negative metastatic breast cancer with a germline
BRCA
mutation, which is a
difficult-to-treat cancer. Moreover, this approval adds further
impetus to our important collaboration with AstraZeneca in
developing cancer therapies."
The approval was based on data from the randomised,
open-label, Phase III OlympiAD
trial which investigated
Lynparza
versus physician's choice of
chemotherapy (capecitabine, eribulin, or vinorelbine). In the
trial, Lynparza significantly prolonged progression-free survival
(PFS) compared with chemotherapy, and reduced the risk of disease
progression or death by 42% (HR 0.58; 95% CI 0.43-0.80; P=0.0009
median 7.0 vs 4.2 months). Patients with measurable disease
taking Lynparza (n=167) experienced an objective response rate of
52% (95% CI 44-60), double the response rate for those in the
chemotherapy arm (n=66) which was 23% (95% CI 13-35). Additionally,
patients experienced a confirmed complete response rate of 7.8%
for Lynparza compared to 1.5% for the chemotherapy arm. The
data from the OlympiAD trial can be found in the June 2017 issue of
the New
England Journal of Medicine.
Susan M. Domchek, Executive Director of the Basser Center
for BRCA at the Abramson Cancer Center of the University of
Pennsylvania, and a national leader on the OlympiAD trials, said:
"Patients diagnosed with BRCA-related metastatic breast cancer are often
younger than other breast cancer patients, and their disease is
often much more aggressive and difficult to treat. While there is
currently no cure for metastatic breast cancer, today's approval
offers a new, targeted option that may help to delay disease
progression for these 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% compared to the chemotherapy arm which
was 8%.
This is the third indication approved for Lynparza in the US, where it has been used to treat nearly
4,000 advanced ovarian cancer patients. Lynparza has the broadest clinical development programme of
any PARP inhibitor, and AstraZeneca and MSD are working together to
deliver Lynparza as quickly as possible to more patients across
multiple settings, including breast, ovarian, prostate and
pancreatic cancers.
Sustainable and Ongoing Externalisation Revenue
Under the oncology collaboration with Merck, announced in July
2017, AstraZeneca is potentially eligible for more than $6 billion
of future Sustainable and Ongoing Externalisation Revenue in the
form of sales-related and approval-related payments in addition to
option payments until 2019. Following this new approval for
Lynparza, AstraZeneca will receive $70 million in
Sustainable and Ongoing Externalisation
Revenue.
About OlympiAD
OlympiAD is a randomised, open-label, multicentre Phase III trial
assessing the efficacy and safety of Lynparza tablets (300 mg twice daily) compared to
physician's choice of chemotherapy in 302 patients with
HER2-negative metastatic breast cancer with germline
BRCA1 or BRCA2 mutations, which are confirmed or suspected to
be deleterious. The international trial was conducted in 19
countries across Europe, Asia, North America and South
America.
Patients in the OlympiAD trial had HER2-negative
gBRCA1- or gBRCA2-mutated breast cancer, which was HR+ or triple
negative, and received Lynparza for metastatic disease. Approximately half of the
patients in the Lynparza and chemotherapy arm of the trial were HR+
(n=152), and approximately half were triple negative (n=150). Among
the 205 patients treated with Lynparza, the median age was 44 years (range: 22 to 76).
Before enrolment, patients had prior treatment with an
anthracycline (unless contraindicated) and a taxane chemotherapy
either in the neoadjuvant, adjuvant or metastatic setting and no
more than two prior lines of chemotherapy for metastatic disease.
Hormone receptor-positive patients had received at least one
endocrine medicine or were not eligible for endocrine medicines.
Prior treatments with endocrine medicines were not counted as prior
lines of chemotherapy.
The primary endpoint of the trial was PFS as measured by a Blinded
Independent Central Review. Secondary endpoints included overall
survival, time to second progression or death, objective response
rate, and effect on health-related quality of life.
About Metastatic Breast Cancer (MBC)
Three main receptors drive tumour growth in breast cancer:
progesterone receptors (PR), estrogen receptors (ER) and HER2
receptors. A patient's breast cancer will test either negative or
positive for these three receptors. If a tumour tests positive for
PR and/or ER, it is considered HR+. If a tumour tests negative for
all three receptors, it is considered triple negative.
MBC is the most advanced stage of breast cancer (Stage IV), and
occurs when cancer cells have spread beyond the initial tumour site
to other parts of the body outside of the breast.
Despite the increase in treatment options during the past three
decades, there is currently no cure for patients diagnosed with MBC
and only 26.9% of patients survive five years after diagnosis.
Thus, the primary aim of treatment is to slow progression of the
disease for as long as possible, improving, or at least
maintaining, a patient's quality of life.
It is estimated that in 2018, there will be approximately 155,000
women in the US living with MBC, and this number is projected to
increase to approximately 160,000 by the year 2020.
About Germline BRCA Mutations
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 (olaparib)
Lynparza is the first
FDA-approved oral poly ADP-ribose polymerase (PARP) inhibitor and
the first targeted treatment to potentially exploit DNA damage
response (DDR) pathway deficiencies, such as BRCA mutations, to preferentially kill cancer cells.
Specifically, in vitro studies have shown that Lynparza-induced cytotoxicity may involve inhibition of
PARP enzymatic activity and increased formation of PARP-DNA
complexes, resulting in DNA damage and cancer cell
death.
Lynparza is being investigated
in a range of DDR-deficient tumour types and is the foundation of
AstraZeneca's industry-leading portfolio of compounds 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. The collaboration is based on increasing evidence that PARP
and MEK inhibitors can be combined with PD-L1/PD-1 inhibitors for a
range of tumour 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 New Oncology as one of AstraZeneca's five
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 personalized 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 & Metabolic
Diseases and Respiratory. The Company also is selectively active in
the areas of autoimmunity, neuroscience and infection. AstraZeneca
operates in over 100 countries and its innovative medicines are
used by millions of patients worldwide.
For more information, please visit www.astrazeneca.com
and follow us on Twitter
@AstraZeneca.
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Adrian Kemp
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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:
12 January 2018
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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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