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 August
2019
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
Indicate
by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F.
Form
20-F X Form 40-F __
Indicate
by check mark if the registrant is submitting the Form 6-K in paper
as permitted by Regulation S-T Rule 101(b)(1):
Indicate
by check mark if the registrant is submitting the Form 6-K in paper
as permitted by Regulation S-T Rule 101(b)(7): ______
Indicate
by check mark whether the registrant by furnishing the information
contained in this Form is also thereby furnishing the information
to the Commission pursuant to Rule 12g3-2(b) under the Securities
Exchange Act of 1934.
Yes __
No X
If
“Yes” is marked, indicate below the file number
assigned to the Registrant in connection with Rule 12g3-2(b):
82-_____________
AstraZeneca PLC
INDEX
TO EXHIBITS
1.
Lynparza
Phase III PAOLA-1 trial met primary endpoint
14
August 2019 07:00 BST
Lynparza Phase
III PAOLA-1 trial met primary endpoint as 1st-line maintenance
treatment with bevacizumab for advanced ovarian
cancer
AstraZeneca and MSD's Lynparza, when added to standard-of-care
bevacizumab, significantly increased the time women lived without
disease progression
AstraZeneca and MSD Inc., Kenilworth, N.J., US (MSD: known as Merck
& Co., Inc. inside the US and Canada) today announced
positive results from the Phase III PAOLA-1 trial in women with
advanced ovarian cancer. The trial, in the
1st-line maintenance
setting, compared Lynparza(olaparib) added to standard-of-care (SoC)
bevacizumab vs. bevacizumab alone in women with or without
BRCA gene mutations.
The trial met its primary endpoint in the intent-to-treat*
population with a statistically-significant and
clinically-meaningful improvement in progression-free survival
(PFS), increasing the time women taking Lynparza plus bevacizumab lived without disease
progression or death vs. those taking bevacizumab alone. The
results, including biomarker sub-group analyses, will be presented
at a forthcoming medical meeting. The safety and tolerability
profiles observed in PAOLA-1 were generally consistent with those
known for each medicine. PAOLA-1 is the second positive Phase III
trial with Lynparza in 1st-line advanced ovarian
cancer.
José Baselga, Executive Vice President, Oncology R&D,
said: "The positive results from the PAOLA-1 trial demonstrate a
clear potential benefit of adding Lynparza to the standard-treatment bevacizumab for
women with advanced ovarian cancer. Following positive results from
the SOLO-1 trial for women with a BRCA gene mutation, the PAOLA-1
trial marks yet another positive Phase III trial
for Lynparza as a 1st-line maintenance treatment for
women with advanced ovarian cancer. We look forward to discussing
the results with global health authorities as soon as
possible."
Roy Baynes, Senior Vice President and Head of Global Clinical
Development, Chief Medical Officer, MSD Research Laboratories,
said: "The Phase III PAOLA-1 trial demonstrates MSD's and
AstraZeneca's continued commitment to improving clinical outcomes
for women with advanced ovarian cancer. In this co-operative group
trial sponsored by ARCAGY Research, maintenance treatment
with Lynparza when added to a standard-of-care treatment
was evaluated in an environment representative of real clinical
practice. By studying Lynparza in this broader patient population, we have
learned more about how it may help even more patients with advanced
ovarian cancer in the future."
Eric Pujade-Lauraine, Medical Director of ARCAGY Research, said:
"The PAOLA-1 trial is a positive example of the strength and
promise of academia-industry collaboration in advancing science and
new treatment options for patients. We greatly appreciate the
commitment of AstraZeneca and MSD in working with academic
cooperative groups in ENGOT and look forward to sharing the full
PAOLA-1 results at a forthcoming medical meeting."
PAOLA-1 is an ENGOT (European Network of Gynaecological Oncological
Trial groups) trial, sponsored by ARCAGY Research (Association de
Recherche sur les CAncers dont GYnécologiques) on behalf of
GINECO (Groupe d'Investigateurs National des Etudes des Cancers
Ovariens et du sein). ARCAGY-GINECO is an academic group
specialising in clinical and translational research in patients'
cancers and a member of the GCIG (Gynecologic Cancer
InterGroup).
About PAOLA-1
PAOLA-1 is a randomised, double-blind Phase III trial testing the
efficacy and safety of Lynparzaadded to SoC bevacizumab vs. bevacizumab alone, as
a 1st-line maintenance treatment for newly-diagnosed advanced FIGO
Stage III-IV high grade serous or endometroid ovarian, fallopian
tube, or peritoneal cancer patients who had a complete or partial
response to 1st-line treatment with platinum-based chemotherapy and
bevacizumab. The intent-to-treat* population refers to all patients
randomised in the trial.
About ovarian cancer
Ovarian
cancer is the eighth most common cause of death from cancer in
women worldwide. In 2018, there were nearly 300,000 new cases
diagnosed and around 185,000 deaths.1 Most women are
diagnosed with advanced (Stage III or IV) ovarian cancer and have a
five-year survival rate of approximately 30%.2 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.3,4,5,6
About Lynparza
Lynparza is a first-in-class PARP inhibitor and the
first targeted treatment to block DNA damage response (DDR) in
cells/tumours harbouring a deficiency in homologous recombination
repair, such as mutations in BRCA1 and/or BRCA2. 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 PARP-dependent tumour types with defects and dependencies
in the DDR pathway.
Lynparza is currently approved in 64 countries,
including those in the EU, for the maintenance treatment of
platinum-sensitive relapsed ovarian cancer, regardless of BRCA
status. It is approved in the US, the EU, Japan and several other
countries as 1st-line maintenance treatment of BRCA-mutated
advanced ovarian cancer following response to platinum-based
chemotherapy. It is also approved in 43 countries, including the US
and Japan, for germline BRCA-mutated, HER2-negative, metastatic
breast cancer, previously treated with chemotherapy; in the EU,
this includes locally-advanced breast cancer. Regulatory reviews
are underway in other jurisdictions for ovarian, breast and
pancreatic cancers.
Lynparza, which is being jointly developed and
commercialised by AstraZeneca and MSD, is approved for the
treatment of advanced ovarian cancer and metastatic breast cancer
and has been used to treat over 25,000 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 GINECO
GINECO
(Groupe d'Investigateurs National des Etudes des Cancers Ovariens
et du sein) is the French Cooperative Group in Oncology labelled by
INCA (Institut National du Cancer, or French NCI) developing and
conducting gynaecological and metastatic breast cancer clinical
trials at the national and international level. Founded in 1993,
the GINECO group is a member of international consortia such as
ENGOT and GCIG.
About ENGOT
ENGOT
(European Network for Gynaecological Oncological Trial groups) is a
research network of the European Society of Gynaecological Oncology
(ESGO). Founded in 2007, ENGOT includes 21 cooperative groups from
25 European countries.
About GCIG
The
GCIG (Gynecological Cancer InterGroup) aims to promote and
facilitate high quality clinical trials in order to improve
outcomes for women with gynaecological cancer. Founded in 1998,
GCIG includes 23 cooperative groups from 28 countries
worldwide.
About the AstraZeneca and MSD strategic oncology
collaboration
In July
2017, AstraZeneca and Merck & Co., Inc., Kenilworth, NJ, US,
known as MSD outside the US 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 Lynparzaand
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, the Company is
committed to advance oncology as a key growth driver for
AstraZeneca focused on lung, ovarian, breast and blood cancers. In
addition to AstraZeneca's main capabilities, the Company is
actively pursuing innovative partnerships and investment that
accelerate the delivery of our strategy, as illustrated by the
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, CVRM and Respiratory. AstraZeneca
operates in over 100 countries and its innovative medicines are
used by millions of patients worldwide. For more
information, please visit astrazeneca.com and
follow us on Twitter @AstraZeneca.
Media
Relations
|
|
|
Gonzalo
Viña
|
|
+44 203
749 5916
|
Rob
Skelding
|
Oncology
|
+44 203
749 5821
|
Rebecca
Einhorn
|
Oncology
|
+1 301
518 4122
|
Matt
Kent
|
BioPharmaceuticals
|
+44 203
749 5906
|
Jennifer
Hursit
|
Other
|
+44
203 749 5762
|
Christina Malmberg
Hägerstrand
|
Sweden
|
+46 8 552 53 106
|
Michele
Meixell
|
US
|
+1 302
885 2677
|
|
|
|
Investor
Relations
|
|
|
Thomas
Kudsk Larsen
|
|
+44 203
749 5712
|
Henry
Wheeler
|
Oncology
|
+44 203
749 5797
|
Christer
Gruvris
|
BioPharmaceuticals
(cardiovascular, metabolism)
|
+44 203
749 5711
|
Nick
Stone
|
BioPharmaceuticals
(respiratory, renal)
|
+44 203
749 5716
|
Josie
Afolabi
|
Other
medicines
|
+44 203
749 5631
|
Craig
Marks
|
Finance,
fixed income
|
+44
7881 615 764
|
Jennifer
Kretzmann
|
Corporate
access, retail investors
|
+44 203
749 5824
|
US
toll-free
|
|
+1 866
381 72 77
|
Adrian Kemp
Company Secretary
AstraZeneca PLC
References
1. The World Health Organization. IARC. Globocan 2018. Available
at: http://gco.iarc.fr/. [Accessed
July 2019].
2. National Cancer Institute. (2019). Cancer Stat Facts: Ovarian
Cancer Available at: https://seer.cancer.gov/statfacts/html/ovary.html [Accessed
August 2019].
3. Moore K et al. Maintenance Olaparib in Patients with Newly
Diagnosed Advanced Ovarian Cancer. Presented at
ESMO October 2018.
4. Raja, F. A., Chopra, N. & Ledermann, J. A. 2012. Optimal
first-line treatment in ovarian cancer. Ann. Oncol. Off. J. Eur.
Soc. Med. Oncol. 23 Suppl 10, x118-127.
5. NHS Choices, Ovarian Cancer Available
at: https://www.nhs.uk/conditions/ovarian-cancer/treatment/Accessed
July 2019].
6. 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:
14 August
2019
|
By: /s/
Adrian Kemp
|
|
Name:
Adrian Kemp
|
|
Title:
Company Secretary
|