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 June
2019
Commission
File Number: 001-11960
AstraZeneca PLC
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Francis Crick Avenue
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
Lynparza nearly
doubled the time patients lived without disease progression from
germline BRCA-mutated metastatic pancreatic
cancer
Lynparza nearly doubled the time patients lived
without disease progression from germline BRCA-mutated
metastatic pancreatic cancer
22% of patients receiving Lynparza remained free of
disease progression after two years vs.
10% on placebo
Lynparza now the first PARP inhibitor to
demonstrate benefit in three different cancer types
3 June 2019 07:00 BST
AstraZeneca
and MSD Inc., Kenilworth, N.J., US (MSD: known as Merck & Co.,
Inc. inside the US and Canada) today announced detailed results
from the Phase III POLO trial at the 2019 American Society of
Clinical Oncology (ASCO) Annual Meeting in Chicago, US (Abs #LBA4).
Results are today also published in The
New England Journal of Medicine (NEJM).
The
POLO trial tested Lynparza (olaparib) tablets as
1st-line maintenance monotherapy for patients with germline
BRCA-mutated (gBRCAm) metastatic adenocarcinoma of the pancreas
(pancreatic cancer) whose disease had not progressed following
standard-of-care platinum-based
1st-line chemotherapy.
Results from
the trial showed a statistically-significant and
clinically-meaningful improvement in progression-free survival
(PFS) for Lynparza vs. placebo, improving
the time without disease progression by a median of 7.4 months for
patients treated with Lynparza vs. 3.8 months for those
on placebo (HR 0.53 [95% CI, 0.35-0.82], p=0.004). More than twice
as many patients showed no disease progression both at one year
(34% on Lynparza vs. 15% on placebo) and
two years (22% vs. 10%, respectively).
José Baselga,
Executive Vice President, Oncology R&D, said: "These
unprecedented results raise new hope for patients that
have seen little progress over a long period of time. From as
early as six months after initiation, more than twice as
many patients taking Lynparza lived without progression
of their disease compared to those on placebo and we are now
working with regulatory authorities to bring Lynparza to patients as
quickly as possible."
Roy
Baynes, Senior Vice President and Head of Global Clinical
Development, Chief Medical Officer, MSD Research Laboratories,
said: "We are encouraged by the results of the POLO trial which
showed a considerable reduction in risk of disease progression or
death with Lynparza for germline
BRCA-mutated metastatic
pancreatic cancer patients who did not progress on chemotherapy.
Currently less than 3% of metastatic pancreatic cancer patients
survive more than five years after diagnosis. The results of this
trial reinforce MSD and AstraZeneca's commitment to develop
innovative treatments for cancers with few options."
Hedy L.
Kindler, MD, co-principal investigator of the POLO trial and
Professor of Medicine, University of Chicago Medicine, said:
"Despite efforts to identify therapies, targeted or combination
treatments to improve patient outcomes, pancreatic cancer remains
an area of high unmet need. The results of the POLO trial may open
the door to a new era of personalised, biomarker-led care in
metastatic pancreatic cancer and reinforces the importance of
knowing BRCA status at diagnosis."
Click to see Kaplan-Meier estimates of PFS by blinded, independent
central review:
https://www.astrazeneca.com/content/dam/az/Image%20Bank/PrgFree02062019.png/jcr:content/renditions/cq5dam.web.1200.PrgFree02062019.png
From The New England Journal of
Medicine, Golan T, et
al. Maintenance Olaparib
for Germline BRCA-Mutated Metastatic Pancreatic
Cancer, Jun 2 [Epub ahead of
print] Copyright © 2019 Massachusetts Medical Society.
Reprinted with permission from the Massachusetts Medical
Society.
The
safety and tolerability profile of Lynparza in the POLO trial was in
line with that observed in prior clinical trials. The most common
adverse events (AEs) ≥20% were fatigue/asthenia (60%), nausea
(45%), abdominal pain (29%), diarrhoea (29%), anaemia (28%),
decreased appetite (25%) and constipation (23%). The most common
≥ grade 3 AEs were anaemia (11%), fatigue/asthenia (5%),
decreased appetite (3%), abdominal pain (2%), vomiting (1%) and
arthralgia (1%). AEs led to dose interruption in 16% of patients
on Lynparza while
5% of patients discontinued treatment.
Lynparza, which is being jointly developed and
commercialised by AstraZeneca and MSD, is approved for multiple
indications in advanced ovarian cancer and metastatic breast cancer
and has been used in over 20,000 patients worldwide.
About POLO
POLO is
a Phase III randomised, double-blinded, placebo-controlled,
multicentre trial of Lynparza tablets (300mg twice
daily) as maintenance monotherapy vs. placebo. The trial randomised
154 patients with gBRCAm metastatic pancreatic cancer whose disease
had not progressed on 1st-line platinum-based chemotherapy.
Patients were randomised (3:2) to receive Lynparza or placebo until disease
progression. The primary endpoint was PFS and key secondary
endpoints included overall survival, time to second disease
progression, overall response rate, disease control rate and
health-related quality of life.
About pancreatic cancer
Pancreatic
cancer is the 12th most common cancer worldwide,1 with 458,918
new cases in 2018 alone.1With the worst
survival rate of all the most common cancers,2 it is the 4th
leading cause of cancer death,3and less than 3% of
patients with metastatic disease survive more than five years after
diagnosis.4 Early diagnosis
of pancreatic cancer is difficult, as often there are no symptoms
until it is too late.5 Around 80% of
patients are diagnosed at the metastatic stage.6
There
are two types of pancreatic cancer. Exocrine tumours, of which the
most common type is pancreatic ductal adenocarcinoma
(PDAC),7 start in the
exocrine cells, where enzymes help to digest food. Neuroendocrine
tumours start in neuroendocrine cells, which produce hormones, such
as insulin,6 that control
different functions of the body.
About BRCA mutations
Breast
cancer susceptibility genes 1/2 (BRCA1 and BRCA2) are human
genes that produce proteins responsible for repairing damaged DNA
and play an important role maintaining the genetic stability of
cells. When either of these genes is mutated, or altered, such that
its protein product either is not made or does not function
correctly, DNA damage may not be repaired properly, and cells
become unstable. As a result, cells are more likely to develop
additional genetic alterations that can lead to
cancer.
About Lynparza
Lynparza (olaparib) 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 (HRR), 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.
Lynparza is currently approved in over 60 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, Canada and Brazil as 1st-line
maintenance treatment of BRCAm advanced ovarian cancer following
response to platinum-based chemotherapy. It is also approved in
nearly 40 countries, including the US and Japan, for germline BRCAm
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
both ovarian cancer and breast cancer.
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 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. 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 for
AstraZeneca 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, Renal &
Metabolism 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.
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References
1 World Health Organisation. International Agency for Research on
Cancer. Estimated number of new cases in 2018, worldwide, all
cancers, both sexes, all ages. Accessed May 2019
from https://gco.iarc.fr/today.
2 Pancreatic Cancer Action. Facts and statistics. Accessed May 2019
from https://pancreaticcanceraction.org/about-pancreatic-cancer/healthcare-professionals/stats-facts/facts-and-statistics/.
3 Hidalgo M et al. Addressing the challenges of pancreatic cancer:
future directions for improving outcomes. 2015: Vol 15, Issue 1,
Pg. 8-18.
4 American Cancer Society. Survival rates for Pancreatic Cancer.
Accessed May 2019 fromhttps://www.cancer.org/cancer/pancreatic-cancer/detection-diagnosis-staging/survival-rates.html.
5 Pancreatic Cancer UK. Signs and symptoms if pancreatic cancer.
Accessed May 2019 fromhttps://www.pancreaticcancer.org.uk/information-and-support/facts-about-pancreatic-cancer/signs-and-symptoms-of-pancreatic-cancer/.
6 Pancreatic Cancer. Some key facts. Accessed May 2019
fromhttps://www.pancreaticcancer.org.uk/media/409815/mp-pancreatic-cancer-briefing-notes.pdf.
7 Pancreatic Cancer UK. Types of pancreatic cancer. Accessed May
2019 fromhttps://www.pancreaticcancer.org.uk/information-and-support/facts-about-pancreatic-cancer/types-of-pancreatic-cancer/.
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:
03 June
2019
|
By: /s/
Adrian Kemp
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|
Name:
Adrian Kemp
|
|
Title:
Company Secretary
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