TIDMAZN
RNS Number : 1622X
AstraZeneca PLC
17 February 2017
This announcement contains inside information
17 February 2017, 07:00 GMT
LYNPARZA MEETS PRIMARY ENDPOINT IN PHASE III
TRIAL IN BRCA-MUTATED METASTATIC BREAST CANCER
Lynparza provided a statistically-significant improvement in
progression-free survival compared to chemotherapy
First positive randomised trial to evaluate the efficacy and
safety of a PARP inhibitor beyond ovarian cancer
AstraZeneca today announced positive results from its Phase III
OLYMPIAD trial comparing Lynparza (olaparib) tablets (300mg twice
daily) to physician's choice of a standard of care chemotherapy in
the treatment of patients with HER2-negative metastatic breast
cancer harbouring germline BRCA1 or BRCA2 mutations. Patients
treated with Lynparza showed a statistically-significant and
clinically-meaningful improvement in progression-free survival
(PFS) compared with those who received chemotherapy (capecitabine,
vinorelbine or eribulin).
Sean Bohen, Executive Vice President, Global Medicines
Development and Chief Medical Officer at AstraZeneca, said: "These
results are positive news for patients with BRCA-mutated metastatic
breast cancer, a disease with a high unmet need, and are the first
positive Phase III data for a PARP inhibitor beyond ovarian cancer.
This is highly encouraging for the development of our broad
portfolio which aims to treat multiple cancers by targeting DNA
damage response pathways."
Initial findings from the OLYMPIAD study indicate that the
safety profile of Lynparza was consistent with previous
studies.
A full evaluation of the OLYMPIAD data is ongoing and the
results will be submitted for presentation at a forthcoming medical
meeting. AstraZeneca will be working with regulatory authorities to
make Lynparza available to patients with this type of breast
cancer.
About Metastatic Breast Cancer
Approximately one in eight women are diagnosed with breast
cancer. Of these patients, approximately one-third are either
diagnosed with or progress to the metastatic stage of the
disease.([i]) 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 OLYMPIAD
OLYMPIAD is a randomised, multi-center Phase III trial assessing
the efficacy and safety of Lynparza (300 mg 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 study was
conducted in 19 countries from across Europe, Asia, North America
and South America.
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).
About Germline BRCA mutations
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. As a result, cells are more likely to develop
additional genetic alterations that can lead to cancer.([ii])
Specific inherited mutations in BRCA1 and BRCA2 increase the
risk of female breast and ovarian cancers, and they have been
associated with increased risks of several additional types of
cancer. Together, BRCA1 and BRCA2 mutations account for about 20 to
25 percent of hereditary breast cancers([iii]) and about 5 to 10
percent of all breast cancers([iv]) . In addition, mutations in
BRCA1 and BRCA2 account for around 15 percent of ovarian cancers
overall([v]) . Breast and ovarian cancers associated with BRCA1 and
BRCA2 mutations tend to develop at younger ages than their
nonhereditary counterparts.
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. Lynparza is the foundation of
AstraZeneca's industry-leading portfolio of compounds 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. 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.
Lynparza is currently being investigated in another separate
non-metastatic breast cancer Phase III study called OLYMPIA. This
study is still open and recruiting patients internationally.
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 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.
Media Enquiries
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Vanessa Rhodes UK/Global +44 203 749 5736
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Investor Relations
Thomas Kudsk Larsen +44 203 749 5712
Craig Marks Finance, Fixed Income, M&A +44 7881 615 764
Henry Wheeler Oncology +44 203 749 5797
Mitchell Chan Oncology +1 240 477 3771
Lindsey Trickett Cardiovascular & Metabolic Diseases +1 240 543 7970
Nick Stone Respiratory +44 203 749 5716
Christer Gruvris Autoimmunity, Neuroscience & Infection +44 203 749 5711
US toll free +1 866 381 7277
Adrian Kemp
Company Secretary, AstraZeneca PLC
[i] Dr Joyce O'Shaughnessy; Extending Survival with Chemotherapy
in MBC" The Oncologist 2005:10
[ii] NCI website - BRCA Fact-sheet ...
https://www.cancer.gov/about-cancer/causes-prevention/genetics/brca-fact-sheet
Last accessed January 2017
[iii] Easton DF. How many more breast cancer predisposition
genes are there? Breast Cancer Research 1999; 1(1):14-17.
[iv] Campeau PM, Foulkes WD, Tischkowitz MD. Hereditary breast
cancer: New genetic developments, new therapeutic avenues. Human
Genetics 2008; 124(1):31-42.
[v] Pal T, Permuth-Wey J, Betts JA, et al. BRCA1 and BRCA2
mutations account for a large proportion of ovarian carcinoma
cases. Cancer 2005; 104(12):2807-16.
This information is provided by RNS
The company news service from the London Stock Exchange
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