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 2017
Commission
File Number: 001-11960
AstraZeneca PLC
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
LYNPARZA:
SIGNIFICANT PFS IN BRCAm BREAST CANCER
5 June
2017 07:00 BST
LYNPARZA SIGNIFICANTLY REDUCES THE RISK OF DISEASE WORSENING OR
DEATH IN PATIENTS WITH BRCA-MUTATED METASTATIC BREAST
CANCER
OlympiAD was the first positive Phase III trial to evaluate
the
efficacy and safety of a PARP inhibitor beyond ovarian
cancer
Lynparza tablets reduced risk of disease worsening or death by
42%
The overall safety profile was consistent with previous trials of
Lynparza
AstraZeneca
today presented positive results from its Phase III OlympiAD trial
that showed a statistically-significant and clinically-meaningful
improvement in progression-free survival (PFS) for patients treated
with Lynparza (olaparib)
tablets (300mg twice daily), compared to treatment with physician's
choice of a standard of care chemotherapy. In addition to meeting
its primary endpoint of PFS assessed by blinded independent central
review (BICR), the trial showed that patients treated with
Lynparza had a 42%
reduction in risk of their disease worsening or death (HR 0.58; 95%
CI 0.43-0.80; p=0.0009; median 7.0 vs 4.2 months) compared to those
who received chemotherapy (capecitabine, vinorelbine,
eribulin).
The
data were presented at the 2017 ASCO Annual Meeting in Chicago,
during today's Plenary
Session
from 15:10-15:25 CDT (Abstract LBA4).[i] The trial
was designated for the "Best of ASCO" selection, underscoring the
importance of these results for patients and physicians, and the
results are published in the
New England Journal of Medicine.
Mark E.
Robson, Clinic Director of the Clinical Genetics Service at
Memorial Sloan Kettering Cancer Center, New York and Principal
Investigator of OlympiAD said, "The OlympiAD data presented today
demonstrate the benefit of olaparib in delaying the progression of
advanced BRCA-mutated breast cancer. With few alternatives
available, a targeted non-chemotherapy oral treatment in this
setting could be a beneficial new option for
patients."
Sean
Bohen, Executive Vice President, Global Medicines Development and
Chief Medical Officer at AstraZeneca, said, "The OlympiAD results
shared today mark the first time a targeted therapy shows benefit
over the current standard of care for patients with HER2-negative
gBRCA-mutated metastatic breast cancer. This also represents an
important milestone for Lynparza as this is the first positive
Phase III trial in which a PARP inhibitor has shown a significant
benefit for patients outside of ovarian cancer."
Patients
in the trial had HER2-negative germline BRCA1 or BRCA2-mutated
breast cancer and were receiving Lynparza as their first, second or
third-line medicine for metastatic disease. Before enrolment,
patients had prior treatment with an anthracycline (unless
contraindicated) and a taxane; hormone receptor-positive patients
received at least one endocrine medicine or were not eligible for
endocrine medicines.i
Secondary
endpoints showed an improvement in time until second progression or
death (PFS2) in the Lynparza arm of the trial, compared to those
treated with chemotherapy (HR 0.57; 95% CI: 0.40-0.83).i In addition, the
objective response rate (ORR) was more than doubled, with 59.9% of
patients in the Lynparza
arm showing response to treatment, compared to 28.8% of patients
treated with chemotherapy.i
A
review of the Lynparza
safety data from the OlympiAD trial did not identify any new safety
signals and the overall safety profile was consistent with previous
trials of Lynparza. There
was a lower incidence of grade ≥3 adverse events in the
Lynparza arm compared to
the chemotherapy arm (36.6% vs 50.5% respectively). A smaller
proportion of patients discontinued treatment in the Lynparza arm
compared to the chemotherapy arm (4.9% vs 7.7%
respectively).
About OlympiAD
OlympiAD
is a randomised, open label, multi-centre Phase III trial assessing
the efficacy and safety of Lynparza (300mg tablets twice daily) to
'physician's choice' chemotherapy (capecitabine, vinorelbine,
eribulin) in 302 patients with HER2-negative metastatic breast
cancer with germline BRCA1 or BRCA2 mutations, which are predicted
or suspected to be deleterious. The international trial was
conducted in 19 countries from across Europe, Asia, North America
and South America.
Within
the eligible patient population, there was a 1:1 ratio between
triple-negative breast cancer (TNBC) and hormone receptor positive
(ER+ and/or PR+) patients.
The
primary endpoint of the trial was progression-free survival (PFS)
as measured by a Blinded Independent Central Review (BICR).
Secondary endpoints include overall survival (OS), time to second
progression or death (PFS2), objective response rate (ORR), and
effect on health-related quality of life (HRQoL).i
About Lynparza
(olaparib)
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. Lynparza
is the foundation of AstraZeneca's industry-leading portfolio of
approved and potential new medicines targeting DNA damage response
(DDR) mechanisms in cancer cells.
Lynparza is currently approved by regulatory health
authorities in the EU for use as monotherapy for the maintenance
treatment of adult patients with platinum-sensitive relapsed
BRCA-mutated (germline and/or somatic) high grade serous epithelial
ovarian, fallopian tube or primary peritoneal cancer who are in
response (complete or partial) to platinum-based
chemotherapy.[i] It is
also approved in the US as monotherapy in patients with deleterious
or suspected deleterious germline BRCA-mutated (as detected by an
FDA-test) advanced ovarian cancer who have been treated with three
or more prior lines of chemotherapy.[ii]
Lynparza is currently being tested in another separate
adjuvant (non-metastatic) breast cancer Phase III trial called
OLYMPIA. This trial is still open and recruiting patients
internationally.
About Metastatic Breast Cancer
Approximately
one in eight women will be diagnosed with breast cancer in the
US.[iii] Of these
patients, approximately one third are either diagnosed with, or
progress to, the metastatic stage of the disease.[iv] Despite
treatment options increasing during the past three decades there is
currently no cure for patients diagnosed with metastatic breast
cancer. Thus, the primary aim of treatment is to slow progression
of the disease for as long as possible, improving, or at least
maintaining, a patient's quality of life.
About Germline BRCA mutations
BRCA1
and BRCA2 are human genes that produce proteins responsible for
repairing damaged DNA and play an important role in maintaining the
genetic stability of cells. When either of these genes is mutated,
or altered, such that its protein is either not made or is faulty,
DNA damage may not be repaired properly. As a result, cells are
more likely to develop additional genetic alterations that can lead
to cancer.[v]
Specific
inherited mutations in BRCA1 and BRCA2 increase the risk of female
breast and ovarian cancers, among others. Together, BRCA1 and BRCA2
mutations account for about 20 to 25% of hereditary breast
cancers[vi] and about
5 to 10% of all breast cancers[vii]. In
addition, mutations in BRCA1 and BRCA2 account for around 15% of
ovarian cancers overall Breast and ovarian cancers associated with
BRCA1 and BRCA2 mutations tend to develop at younger ages than
their nonhereditary counterparts.
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 Oncology as one of AstraZeneca's five 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.
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Adrian Kemp
Company Secretary, AstraZeneca PLC
References
[i] Robson M., Im SA., Senkus E., et al, OlympiAD: Phase III
trial of olaparib monotherapy versus chemotherapy for patients
(pts) with HER2-negative metastatic breast cancer (mBC) and a
germline BRCA mutation (gBRCAm), Presented at the American Society
of Clinical Oncology Annual Meeting, Chicago; June 2-6, 2017.
http://abstracts.asco.org/199/AbstView_199_186720.html.
Last accessed June 2017.
[i] Committee for Medicinal Products for Human Use (CHMP).
CHMP summary of positive opinion for Lynparza. Available at:
http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion_-_Initial_authorisation/human/003726/WC500176336.pdf.
Last accessed April 2017.
[ii] US Food and Drug Administration (FDA). Lynparza
Highlights of Prescribing Information. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206162lbl.pdf
Last accessed April 2017.
[iii] National Cancer Institute. Breast Cancer Fact Sheet.
Available at: https://www.cancer.gov/types/breast/risk-fact-sheet
Last accessed April 2017.
[iv] Dr Joyce O'Shaughnessy; Extending Survival with
Chemotherapy in MBC" The Oncologist 2005:10
[v] NCI website - BRCA Fact-sheet … https://www.cancer.gov/about-cancer/causes-prevention/genetics/brca-fact-sheet.
[vi] Easton DF. How many more breast cancer predisposition
genes are there? Breast Cancer Research 1999;
1(1):14-17.
[vii] Campeau PM, Foulkes WD, Tischkowitz MD. Hereditary
breast cancer: New genetic developments, new therapeutic avenues.
Human Genetics 2008; 124(1):31-42.
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:
05 May 2017
|
By: /s/
Adrian Kemp
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|
Name:
Adrian Kemp
|
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Title:
Company Secretary
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