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 October 2016
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
Positive results in AstraZeneca Lynparza trial dated 26th October 2016
This announcement contains inside information
26
October 2016 07:00
LYNPARZA PHASE III SOLO-2 TRIAL SHOWS SIGNIFICANT PROGRESSION-FREE
SURVIVAL BENEFIT
Trial studied Lynparza as maintenance treatment for women with
BRCA-mutated metastatic ovarian cancer
Initial findings show safety profile with Lynparza tablets was
consistent with
previous studies
AstraZeneca
today announced positive results from the Phase III SOLO-2 trial
designed to determine the efficacy of Lynparza (olaparib) tablets (300mg
twice daily) as a monotherapy for the maintenance treatment of
platinum-sensitive relapsed, BRCA-mutated ovarian cancer. Results
from the trial demonstrate a clinically-meaningful and
statistically-significant improvement of progression-free survival
(PFS) among patients treated with Lynparza compared to placebo and
provide additional evidence to support the potential use of
Lynparza in this patient
population.
Importantly,
the median PFS in the Lynparza arm of SOLO-2 substantially
exceeded that observed in the Phase II maintenance study in
patients with platinum-sensitive relapsed ovarian cancer (Study
19).1
Sean
Bohen, Executive Vice President, Global Medicines Development and
Chief Medical Officer at AstraZeneca, said: "We are pleased with
the robust improvement in progression-free survival demonstrated by
Lynparza in the SOLO-2
trial. We will work with regulatory authorities to make
Lynparza tablets available
as quickly as possible to patients with ovarian cancer. We remain
committed to investigating the full potential of Lynparza, both as monotherapy and in
combinations, and to identifying all patients who may benefit from
this important medicine."
Initial
findings demonstrate that safety profile with Lynparza tablets was consistent with
previous studies. Full results of SOLO-2 will be presented at a
forthcoming medical meeting.
Today's
positive results follow the Fast Track Designation for Lynparza by the US FDA earlier this
year, in patients with a BRCA mutation who have platinum-sensitive,
relapsed ovarian cancer.
About SOLO-2
SOLO-2
was a Phase III, multicentre trial designed to determine the
efficacy of Lynparza
tablets as a maintenance monotherapy compared with placebo, in
patients with platinum-sensitive relapsed or recurrent BRCA-mutated
(BRCAm) ovarian cancer. In SOLO-2, patients with either germline or
somatic BRCAm status were eligible for enrolment, although due to
the lack of widespread availability of tumour BRCA testing, most
patients were enrolled on blood-based germline testing. Those few
patients who were enrolled based on a tumour test were also found
to have a germline BRCA mutation. Patients were randomised to
receive either Lynparza
tablets (300mg twice daily) or placebo until disease
progression.[1]
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 2 prior lines of
platinum-based chemotherapy.
About AstraZeneca in ovarian cancer
Worldwide, ovarian cancer is the 7th most commonly diagnosed cancer[2]
and the 8th most common cause of cancer death in
women.[3]
The risk of developing ovarian cancer
is increased in women with specific inherited genetic
abnormalities, including BRCA mutations. AstraZeneca is committed
to the continued development of our R&D portfolio for ovarian
cancer, with a focus on improved care for all patients, including
the development of targeted therapies for patients with specific
gene mutations such as BRCA.
About Lynparza
Lynparza (olaparib) is an
innovative, first-in-class oral poly ADP-ribose polymerase (PARP)
inhibitor that may exploit tumour DNA damage response (DDR) pathway
deficiencies to preferentially kill cancer cells. It is approved by
regulatory authorities in the EU and US for the treatment of women
with BRCAm ovarian cancer. Lynparza is the foundation of AstraZeneca's
industry-leading portfolio of compounds targeting DNA damage
response (DDR) mechanisms in cancer cells.
About ENGOT
ENGOT
(European Network for Gynaecological Oncological Trial groups) is a
research network of the European Society of Gynaecological Oncology
(ESGO) and was founded in 2007. Currently, ENGOT consists of 19
cooperative groups from 15 European countries. ENGOT's ultimate
goal is to bring the best treatment to gynaecological cancer
patients through the best science, and enabling every patient in
every European country to access a clinical trial. ENGOT
coordinates and promotes multinational clinical trials within
Europe on patients with gynaecological cancer. This coordination is
particularly relevant for academic clinical trials, translational
research, research on rare diseases, and for clinical trials
sponsored by the industry.
About GINECO
GINECO
(Groupe d'Investigateurs National pour l'Etude des Cancers de
l'Ovaire et du sein) is the French Cooperative Group in Oncology
labelled by INCA (Institut National du Cancer or French NCI) for
developing and conducting gynaecological and advanced breast cancer
clinical trials at the national and international level. The
network is nationwide with 700 specialized investigators belonging
to more than 150 public or private oncology units. The GINECO group
was founded in 1993 and is member of international consortia such
as ENGOT and GCIG (Gynecologic Cancer InterGroup). GINECO was the
ENGOT leading group for SOLO-2 trial.
About AstraZeneca in Oncology
AstraZeneca
has a deep-rooted heritage in Oncology and offers a quickly growing
portfolio of new medicines that have the potential to transform
patients' lives and the Company's future. With at least 6 new
medicines to be launched between 2014 and 2020 and a broad pipeline
of small molecules and biologics in development, we are committed
to advancing New Oncology as one of AstraZeneca's six 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, the genetic drivers of cancer 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 main 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.
CONTACTS
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Skelding
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Adrian Kemp
Company Secretary, AstraZeneca PLC
References
[1] National Institutes of
Health. Olaparib Treatment in BRCA Mutated Ovarian Cancer Patients
After Complete or Partial Response to Platinum Chemotherapy.
Available at: http://clinicaltrials.gov/show/NCT01874353. Last
accessed October 2016.
[2] Cancer Research UK.
Ovarian cancer incidence statistics. Available at:
http://www.cancerresearchuk.org/cancer-info/cancerstats/types/ovary/incidence/uk-ovarian-cancer-incidence-statistics.
Last accessed June 2016.
[3] Cancer Research UK.
Ovarian cancer mortality statistics. Available at:
http://www.cancerresearchuk.org/cancer-info/cancerstats/types/ovary/mortality/
Last accessed June 2016.
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.
AstraZeneca
PLC
Date:
26 October
2016
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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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