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 May 2018
Commission
File Number: 001-11960
AstraZeneca PLC
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
MA approves
Lynparza: maintenance ovarian cancer
8 May 2018 11:00 BST
LYNPARZA TABLETS RECEIVE EU
APPROVAL FOR THE TREATMENT OF PLATINUM-SENSITIVE RELAPSED OVARIAN
CANCER
Women with platinum-sensitive ovarian cancer now have access to
maintenance therapy with AstraZeneca and MSD's Lynparza,
regardless of BRCA status
Lynparza has over five years' efficacy and safety follow-up
data
New formulation reduces dosing to two tablets twice
daily
AstraZeneca and Merck & Co., Inc., Kenilworth, NJ, US (known as
MSD outside the US and Canada) today announced that the European
Medicines Agency (EMA) has approved 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, regardless of BRCA status.
Dave Fredrickson, Executive Vice President, Head of the Oncology
Business Unit at AstraZeneca, said: "With this new approval
for Lynparza, we will now be able to offer more women with
platinum-sensitive ovarian cancer, regardless of their
BRCA
status, a chance to achieve long-term
disease control with an oral medicine that has a well-characterised
safety and tolerability profile."
Roy Baynes, Senior Vice President and Head of Global Clinical
Development, Chief Medical Officer, MSD Research Laboratories,
said: "This is an important development for the thousands of women
in Europe living with advanced ovarian cancer, historically a
difficult-to-treat disease. Working with AstraZeneca, we are able
to bring this innovative, targeted treatment that helps delay
progression of the disease to a broader group of
women."
The EU approval was based on two randomised trials, SOLO-2 and
Study 19, which showed that Lynparza reduced the risk of disease progression or death
for platinum-sensitive relapsed ovarian cancer patients compared to
placebo.
Table 1. Summary of key efficacy results from randomised
trials:
|
Analysis
|
SOLO-2
(germline BRCA-mutated
platinum-sensitive
relapsed)
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<0.00001; median 8.4 vs
4.8 months)*
|
* By investigator-assessed analysis
In
SOLO-2, the investigator-assessed analysis of PFS was supported
with a blinded, independent, central radiological review of PFS,
which showed a two-year difference in median PFS between
Lynparza and placebo (HR
0.25 [95% CI, 0.18-0.35], p<0.0001; median 30.2 months vs 5.5
months). Overall survival (OS) data from SOLO-2 is currently
immature.
In the
final analysis of Study 19, with greater than five years of
follow-up, the significant improvement in PFS translated into
improvements in other key efficacy endpoints, regardless of
BRCA status (Table 2).
Additionally, the analysis showed 13% of patients treated with
Lynparza remained
progression-free and on therapy for five years or more
years.
Table 2. Summary of other key efficacy endpoints from Study
19:
|
Analysis
|
Study
19
(platinum-sensitive
relapsed)
n=265
|
|
Lynparza
|
Placebo
|
|
Time to
first subsequent therapy or death*
|
HR 0.39
(95% CI, 0.30-0.52), p<0.00001;
median
13.3 months vs. 6.7 months
|
|
OS
|
HR 0.73
(95% CI, 0.55-0.95), p=0.02138**;
median
29.8 vs. 27.8 months***
|
*
statistical tests not adjusted for multiplicity
**
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. The majority of patients on
Lynparza
remained on the starting dose and only
6-11% of patients discontinued treatment due to an adverse
event.
Approximately half of women with high grade epithelial ovarian
cancer are expected to have deficiencies in homologous
recombination repair (HRR), an important DNA damage response (DDR)
pathway. Mutations most often occur within one of the
BRCA
genes, however other gene mutations
can also impact the HRR pathway. While there are currently no
routine tests to identify patients with these deficiencies
beyond BRCA mutations, responsiveness to platinum-based
chemotherapy can predict sensitivity to PARP
inhibition.
Lynparza, the first PARP
inhibitor approved, was initially licensed in Europe as a capsule
formulation for women with BRCA-mutated platinum-sensitive relapsed ovarian
cancer. The new tablet formulation, which reduces dosing from eight
capsules twice daily to two tablets twice daily, will now be
available for a broader group of women with platinum-sensitive
relapsed ovarian cancer.
Lynparza tablets were also
recently submitted to the EMA for approval in patients with
BRCA-mutated, HER2-negative metastatic breast cancer
based upon the successful Phase III OlympiAD
trial.
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 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 and
Groupe d'Investigateurs National pour l'Etude des Cancers de
l'Ovaire et du sein, 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 randomised, double-blinded, placebo-controlled,
multi-centre trial, which evaluated the efficacy and safety
of Lynparza 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 DDR-pathway
dependencies 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-dependent 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 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 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, Renal &
Metabolism 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:
08 May 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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