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 February
2018
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
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United
Kingdom
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
Lynparza CHMP for
ovarian cancer maintainance
This announcement contains inside information
23 February 2018 12:30 BST
LYNPARZA RECEIVES POSITIVE
EU CHMP OPINION IN PLATINUM-SENSITIVE RELAPSED OVARIAN
CANCER
AstraZeneca and MSD's new Lynparza tablet formulation
recommended for maintenance therapy regardless of BRCA
status
AstraZeneca
and Merck & Co., Inc., Kenilworth, NJ, US (known as MSD outside
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 a marketing authorisation
of Lynparza (olaparib)
tablets (300mg twice daily) for use as a maintenance therapy for
patients with platinum-sensitive relapsed high grade, epithelial
ovarian, fallopian tube, or primary peritoneal cancer who are in
complete response or partial response to platinum-based
chemotherapy. Lynparza is
recommended for treatment in this setting regardless of patients'
BRCA mutation
status.
Sean
Bohen, Executive Vice President, Global Medicines Development and
Chief Medical Officer at AstraZeneca, said: "The data show that
Lynparza provides long-term
disease control, delaying the need for further chemotherapy for
this broader group of women with platinum-sensitive relapsed
ovarian cancer, irrespective of their BRCA status. It also offers a
well-characterised safety and tolerability profile, which is
critical to help enable patients to stay on
treatment."
Roy
Baynes, Senior Vice President and Head of Global Clinical
Development, Chief Medical Officer, MSD Research Laboratories,
said: "We welcome this positive opinion based upon data which
indicate the potential impact for Lynparza as maintenance therapy for
women with platinum-sensitive relapsed ovarian cancer. We look
forward to our continued work with AstraZeneca to bring
Lynparza to patients in the
EU."
The CHMP recommendation is based on two randomised trials, SOLO-2
and Study 19, which showed Lynparza reduced the risk of disease progression or death
for platinum-sensitive relapsed patients compared to
placebo.
Summary of key efficacy results from randomised
trials:
Analysis
|
SOLO-2
[germline BRCA-mutated]
n=295
|
Study 19
[platinum-sensitive relapsed]
n=265
|
Lynparza
|
Placebo
|
Lynparza
|
Placebo
|
Reduction in the risk of disease progression or death
(PFS)
|
70%
(HR 0.30 [95% CI, 0.22-0.41], P<0.0001; median 19.1 vs
5.5 months)*
|
65%
(HR 0.35 [95% CI, 0.25-0.49], P<0.0001; median 8.4 vs 4.8
months)*
|
Reduction in the risk of death (OS)
|
Data not yet mature
|
27%
(HR 0.73 [95% CI, 0.55-0.95], P=0.02138**;
median
29.8 vs 27.8 months)***
|
PFS =
progression-free survival; OS = overall survival
* By
investigator-assessed analysis
**
P-value considered nominal as criterion for statistical
significance (P<0.0095) not met
*** Not
adjusted for treatment crossover
The
most frequently observed adverse reactions across clinical trials
in patients receiving Lynparza monotherapy (≥ 10%) were
nausea, vomiting, diarrhoea, dyspepsia, fatigue, headache,
dysgeusia, decreased appetite, dizziness and anaemia.
Lynparza, the first poly ADP-ribose polymerase (PARP)
inhibitor approved, was initially licensed as a capsule
formulation. The new tablet formulation will reduce dosing from 8
capsules twice daily to 2 tablets twice daily.
Lynparza is available in nearly 60 countries and has treated
more than 20,000 patients globally. It has the broadest clinical
development programme of any PARP inhibitor, and AstraZeneca and
MSD are working together to bring Lynparza to more patients across
multiple cancers. In January 2018, Lynparza was approved by the US FDA for
use in metastatic breast cancer, becoming the first PARP inhibitor
licensed beyond ovarian cancer.
About Ovarian Cancer in Europe
Among
women in Europe, ovarian cancer is the fifth most common cancer and
the sixth leading cause of cancer death. The five-year survival
rate for ovarian cancer in Europe is 38%. In 2012, there were
nearly 65,000 new cases diagnosed and around 42,700 deaths. As
there is no cure for relapsed ovarian cancer, the primary aim of
treatment is to slow progression of the disease for as long as
possible and improve or maintain the patient's quality of
life.
About SOLO-2
SOLO-2
was a Phase III, randomised, double-blinded, multicentre trial
designed to determine the efficacy of Lynparza tablets compared to placebo as
maintenance monotherapy in patients with platinum-sensitive
relapsed or recurrent germline BRCA-mutated ovarian, fallopian tube
and primary peritoneal cancer. The trial, conducted in
collaboration with the European Network for Gynaecological
Oncological Trial Groups (ENGOT) and Groupe d'Investigateurs
National pour l'Etude des Cancers de l'Ovaire et du sein (GINECO),
randomised 295 patients with documented germline BRCA1 or BRCA2 mutations who had received at
least two prior lines of platinum-based chemotherapy and were in
complete or partial response. Eligible patients were randomised to
receive 300mg Lynparza
tablets twice daily or placebo tablets twice daily.
About Study 19
Study
19 was a Phase II, randomised, double-blinded, placebo-controlled,
multicentre trial, which evaluated the efficacy and safety of
Lynparza capsules compared
with placebo in relapsed, high-grade serous ovarian cancer
patients. The trial randomised 265 patients regardless of
BRCA mutation status and
who had completed at least two courses of platinum-based
chemotherapy and their most recent treatment regimen. Eligible
patients were randomised to receive Lynparza maintenance monotherapy at a
dose of 400mg per day or matching placebo.
About Lynparza
(olaparib)
Lynparza is a first-in-class poly ADP-ribose polymerase
(PARP) inhibitor and the first targeted treatment to potentially
exploit tumour DNA damage response (DDR)-pathway deficiencies 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 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 & 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
Company Secretary
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:
23 February
2018
|
By: /s/
Adrian Kemp
|
|
Name:
Adrian Kemp
|
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Title:
Company Secretary
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