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 December
2018
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
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United
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
FDA
approves Lynparza as 1L maintenance therapy
19 December 2018 18:30 GMT
Lynparza approved by US FDA for 1st-line
maintenance
therapy in BRCA-mutated advanced ovarian
cancer
AstraZeneca and MSD's Lynparza reduced the risk of disease
progression or death by 70% compared to placebo following response
to platinum-based chemotherapy
First PARP inhibitor approved in 1st-line maintenance for BRCAm
advanced ovarian cancer
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 for the maintenance treatment of adult
patients with deleterious or suspected deleterious germline or
somatic BRCA-mutated (gBRCAm or sBRCAm) advanced epithelial ovarian, fallopian tube or
primary peritoneal cancer who are in complete or partial response
to first-line platinum-based chemotherapy, as detected by an
FDA-approved companion diagnostic test.
This is the first regulatory approval for a PARP inhibitor in the
1st-line maintenance setting for BRCAm advanced ovarian cancer. The approval was based
on positive results from the pivotal Phase
III SOLO-1
trial in
which Lynparza reduced the
risk of disease progression or death by 70percent in
patients with BRCAm
advanced ovarian cancer who were in complete or partial response to
platinum-based chemotherapy (HR 0.30 [95% CI 0.23-0.41],
p<0.0001) compared to placebo following platinum-based
chemotherapy. The safety
profile of Lynparza was consistent with previous
trials.
Dave Fredrickson, Executive Vice President, Head of the Oncology
Business Unit, AstraZeneca, said: "Women with ovarian cancer are
often first diagnosed with advanced disease, which is associated
with poor outcomes. In SOLO-1, Lynparza in the first-line maintenance setting
reduced the risk of disease progression or death by 70 percent for
patients with BRCAm advanced ovarian cancer. Today's approval is a
critical advancement and brings us closer to our goal of helping
these patients achieve long-term remission."
Roy Baynes, Senior Vice President and Head of Global Clinical
Development, Chief Medical Officer, MSD Research Laboratories,
said: "The expanded approval of Lynparza based upon the SOLO-1 trial has the
potential to change medical practice and reinforces the importance
of knowing a woman's BRCA status at diagnosis. We continue to work in
collaboration with AstraZeneca on our overall goal of improving
outcomes for patients."
In the SOLO-1 trial, with median 41 months of follow-up, the median
progression-free survival (PFS) for patients treated
with Lynparza was not reached compared to 13.8 months for
patients treated with placebo. Sixty percent of patients
receiving Lynparza remained progression-free at three years
compared to 27 percent of patients receiving placebo. The data from
the SOLO-1 trial can be found in the 21 October 2018 online issue
of the New
England Journal of Medicine.
Kathleen Moore, co-principal investigator of the SOLO-1 trial and
Associate Director for Clinical Research, Stephenson Cancer Center
at The University of Oklahoma, Oklahoma City, Oklahoma, said:
"SOLO-1 is truly a landmark trial in gynecologic cancer. This
approval will likely change the way we treat women
with BRCA-mutated advanced ovarian cancer. The ability to
offer this important first-line maintenance treatment option to
eligible patients may slow down or even stop the natural course of
disease progression."
AstraZeneca and MSD are exploring additional trials in advanced
ovarian cancer, including the ongoing GINECO/ENGOTov25 Phase III
trial, PAOLA-1. This trial is testing the effect
of Lynparzain combination with bevacizumab as a maintenance
treatment for patients with newly-diagnosed advanced ovarian
cancer, regardless of their BRCA status. Results are expected during the
second half of 2019.
Financial considerations
Under the oncology collaboration with MSD and following this new
approval for Lynparza, AstraZeneca will receive $70 million as Ongoing
Externalisation Revenue.
About SOLO-1
SOLO-1 is a Phase III randomised, double-blinded,
placebo-controlled, multicentre trial to evaluate the efficacy and
safety of Lynparza tablets (300mg twice daily) as maintenance
monotherapy compared with placebo, in patients
with BRCAm advanced ovarian cancer following
1st-line
platinum-based chemotherapy. The trial randomised 391 patients with
a deleterious or suspected deleterious germline or
somatic BRCA1 or BRCA2 mutation who were in clinical
complete or partial response following platinum-based chemotherapy. Patients
were randomized (2:1) to receive Lynparza or placebo for up to two years or until
disease progression. Patients who had a partial response at two
years were permitted to stay on therapy at the investigator's
discretion. The primary endpoint was PFS and key secondary
endpoints included time to second disease progression or death,
time to first subsequent treatment and overall
survival.
About Lynparza
Lynparza is a
first-in-class 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. 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 advanced ovarian cancer and
metastatic breast cancer and has been used in over 20,000 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.
About ovarian cancer
Ovarian
cancer is a leading cause of cancer death in women worldwide, with
a five-year survival rate of 19%.[i] In
2018, there were over 295,000 new cases diagnosed and around
185,000 deaths.[ii] For
newly-diagnosed advanced ovarian cancer, the primary aim of
treatment is to delay progression of the disease for as long as
possible and maintain the patient's quality of life with the intent
of achieving complete remission or cure.[iii],[iv],[v],[vi]
About BRCA mutations
BRCA1 and BRCA2 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.
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 a key growth driver for
AstraZeneca 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
www.astrazeneca.com and follow us on Twitter
@AstraZeneca.
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Adrian Kemp
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AstraZeneca PLC
[i] American Cancer Society. Survival
Rates for Ovarian Cancer, by Stage. Available at:
https://www.cancer.org/cancer/ovarian-cancer/detection-diagnosis-staging/survival-rates.html.
Accessed: October 2018
[ii] Globocan 2018
http://gco.iarc.fr/
[iii] Moore K et al. Maintenance
Olaparib in Patients with Newly Diagnosed Advanced Ovarian Cancer.
Presented at ESMO October 2018
[iv] Raja, F. A., Chopra, N.
& Ledermann, J. A. Optimal first-line treatment in ovarian
cancer. Ann. Oncol. Off. J. Eur. Soc. Med. Oncol. 23 Suppl 10,
x118-127 (2012
[v] NHS
Choices, Ovarian Cancer Accessed
https://www.nhs.uk/conditions/ovarian-cancer/treatment/ in
September 2018
[vi] Ledermann.et al. 2013.
Newly diagnosed and relapsed epithelial ovarian carcinoma: ESMO
Clinical Practice.
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 December
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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