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 March 2017
Commission
File Number: 001-11960
AstraZeneca PLC
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12g3-2(b): 82-_____________
15 March 2017 07:00GMT
LYNPARZA PHASE
III SOLO-2 DATA DEMONSTRATE PROGRESSION-FREE SURVIVAL BENEFIT IN
BRCA-MUTATED OVARIAN CANCER AS MAINTENANCE THERAPY
Lynparza reduced risk of disease progression by 70% with an
investigator-assessed progression-free survival of 19.1 months vs
5.5 months with placebo
Blinded independent central review showed impressive
progression-free survival of 30.2 months vs 5.5 months with
placebo
Lynparza tablets demonstrated a safety profile generally consistent
with previous studies, including a low incidence of haematological
toxicity
AstraZeneca today presented results from the Phase III SOLO-2 trial
demonstrating a significant improvement in progression-free
survival (PFS) in germline BRCA-mutated (gBRCA),
platinum-sensitive, relapsed ovarian cancer patients treated
with
Lynparza (olaparib)
tablets (300mg twice daily) compared with placebo in the
maintenance setting. The trial met its primary endpoint of
investigator assessed PFS (HR 0.30; 95% CI 0.22 to 0.41;
P<0.0001; median 19.1 months vs 5.5 months).
PFS as measured by Blinded Independent Central Review (BICR)
evaluation,
a pre-specified analysis supporting the primary endpoint,
demonstrated a median PFS of 30.2 months vs 5.5 months for placebo,
representing an improvement of 24.7 months (HR 0.25; 95% CI
0.18-0.35; P<0.0001).
Additionally, a statistically-significant benefit in time to second
progression or death (PFS2) was also seen in patients treated
with
Lynparza (HR
0.50; 95% CI 0.34 to 0.72; P=0.0002; median not reached vs 18.4
months) compared with placebo, as well as improvements in other key
secondary endpoints.
Progression-Free
Survival by investigator and BICR assessment:
|
Analysis
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Median progression-free survival, months
|
Hazard ratio
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|
Investigator-assessed
analysis
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Lynparza
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19.1
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0.30
(95% CI, 0.22-0.41), P<0.0001
|
|
Placebo
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5.5
|
|
Blinded
Independent Central Review
|
Lynparza
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30.2
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0.25
(95% CI, 0.18-0.35), P<0.0001
|
|
Placebo
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5.5
|
These results, presented at the Society of Gynecologic Oncology
Annual Meeting on Women's Cancer in National Harbor, USA, build
upon prior data in this setting, demonstrating the benefit
of Lynparza as a maintenance therapy in relapsed ovarian
cancer.
Eric
Pujade-Lauraine, Head of the Women Cancers and Clinical Research
Department at Hôpitaux Universitaires Paris Centre, site
Hôtel-Dieu, AP-HP and Principal Investigator of SOLO-2, said:
"Today's results are very encouraging, as they build upon previous
trials examining Lynparza
in platinum-sensitive relapsed BRCA-mutated ovarian cancer. Most
importantly, patients were able to maintain quality of life while
experiencing an impressive delay in disease progression,
demonstrating the benefits of Lynparza tablets for these women whose
cancer is often difficult to treat."
Sean
Bohen, Executive Vice President, Global Medicines Development and
Chief Medical Officer at AstraZeneca, said: "We are extremely
pleased with the results from SOLO-2, which support the potential
benefit of Lynparza tablets
as a maintenance therapy for patients with relapsed ovarian cancer.
The tablet formulation may offer patients a reduced pill burden for
Lynparza and a safety
profile that is generally consistent with previous trials. We will
work with regulatory authorities to make Lynparza tablets available to patients
as quickly as possible."
The
safety profile for patients treated with Lynparza tablets during the trial was
consistent to those observed with the currently-approved capsule
formulation. Any adverse events (AE) Grade ≥3 were reported
in 36.9% of patients treated with Lynparza and in 18.2% of patients who
received placebo. The most common non-haematological AEs reported
at a frequency of ≥20% were nausea (75.9% [grade ≥3,
2.6%]), fatigue/asthenia (65.6% [grade ≥3, 4.1%]), and
vomiting (37.4% [≥3, 2.6%]).
The
most common haematological AEs reported in the Lynparza arm versus placebo were
anaemia (43.6% [grade ≥3, 19.5%]), neutropenia (19.5% [grade
≥3, 5.1%]), and thrombocytopenia (13.8% [grade ≥3,
1.0%]).
The
300mg twice-daily tablet dose reduces the pill burden for patients
from sixteen capsules to four tablets per day.
NOTES TO EDITORS
About SOLO-2
SOLO-2
was a Phase III, randomised, double-blind, 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 gBRCA-mutated (BRCAm)
ovarian 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 2 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 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. In a previous
study Lynparza capsules were shown to result in a significant
improvement in PFS compared to placebo in platinum-sensitive,
relapsed ovarian cancer (PSR OC) patients (HR 0.35; 95% CI
0.25-0.49; p <0.0001) as well as in the subgroup of patients
whose tumours harbour BRCA mutations (HR 0.18; 95% CI
0.10-0.31; p <0.0001).
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 ovarian cancer
Worldwide, ovarian cancer is the 7th
most commonly diagnosed
cancer1
and the 8th
most common cause of cancer death in
women.2
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 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 &
Me
tabolic 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
References
1.
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.
2.
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:
15 March 2017
|
By: /s/
Adrian Kemp
|
|
|
Name:
Adrian Kemp
|
|
|
Title:
Company Secretary
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