TIDMAZN
RNS Number : 7898B
AstraZeneca PLC
12 January 2018
12 January 2018 16:10 GMT
LYNPARZA APPROVED BY US FDA IN GERMLINE BRCA-MUTATED
METASTATIC BREAST CANCER
Lynparza is the first and only PARP inhibitor approved for use
beyond ovarian cancer
Lynparza reduced the risk of disease progression or death by
42%
compared to standard of care chemotherapy
AstraZeneca and Merck & Co., Inc., Kenilworth, N.J., US
(Merck: known as MSD outside the US and Canada) today announced
that the US Food and Drug Administration (FDA) has approved
Lynparza (olaparib), for use in patients with deleterious or
suspected deleterious germline BRCA-mutated (gBRCAm), human
epidermal growth factor receptor 2 (HER2)-negative metastatic
breast cancer who have been previously treated with chemotherapy in
the neoadjuvant, adjuvant or metastatic setting. Patients with
hormone receptor positive (HR+) breast cancer should have been
treated with a prior endocrine therapy or be considered
inappropriate for endocrine therapy. Patients are selected for
therapy based on an FDA-approved companion diagnostic from Myriad
Genetics.
Dave Fredrickson, Executive Vice President, Head of the Oncology
Business Unit, AstraZeneca, said: "This new approval for Lynparza
makes it the first and only PARP inhibitor approved in metastatic
breast cancer, and the only PARP inhibitor approved beyond ovarian
cancer. This is significant for breast cancer patients, as the
identification of BRCA status, in addition to hormone receptor and
HER2 status, becomes a potentially critical step in the management
of their disease."
Roy Baynes, Senior Vice President and Head of Global Clinical
Development, Chief Medical Officer, Merck Research Laboratories
said: "This additional approval for Lynparza represents an
important advance for women with HER2-negative metastatic breast
cancer with a germline BRCA mutation, which is a difficult-to-treat
cancer. Moreover, this approval adds further impetus to our
important collaboration with AstraZeneca in developing cancer
therapies."
The approval was based on data from the randomised, open-label,
Phase III OlympiAD trial which investigated Lynparza versus
physician's choice of chemotherapy (capecitabine, eribulin, or
vinorelbine). In the trial, Lynparza significantly prolonged
progression-free survival (PFS) compared with chemotherapy, and
reduced the risk of disease progression or death by 42% (HR 0.58;
95% CI 0.43-0.80; P=0.0009 median 7.0 vs 4.2 months). Patients with
measurable disease taking Lynparza (n=167) experienced an objective
response rate of 52% (95% CI 44-60), double the response rate for
those in the chemotherapy arm (n=66) which was 23% (95% CI 13-35).
Additionally, patients experienced a confirmed complete response
rate of 7.8% for Lynparza compared to 1.5% for the chemotherapy
arm. The data from the OlympiAD trial can be found in the June 2017
issue of the New England Journal of Medicine.
Susan M. Domchek, Executive Director of the Basser Center for
BRCA at the Abramson Cancer Center of the University of
Pennsylvania, and a national leader on the OlympiAD trials, said:
"Patients diagnosed with BRCA-related metastatic breast cancer are
often younger than other breast cancer patients, and their disease
is often much more aggressive and difficult to treat. While there
is currently no cure for metastatic breast cancer, today's approval
offers a new, targeted option that may help to delay disease
progression for these patients."
The most common adverse reactions (>=20%) in the OlympiAD
trial of patients who received Lynparza were nausea (58%), anaemia
(40%), fatigue (including asthenia) (37%), vomiting (30%),
neutropenia (27%), respiratory tract infection (27%), leukopenia
(25%), diarrhoea (21%), and headache (20%). The percentage of
patients who discontinued treatment in the Lynparza arm was 5%
compared to the chemotherapy arm which was 8%.
This is the third indication approved for Lynparza in the US,
where it has been used to treat nearly 4,000 advanced ovarian
cancer patients. Lynparza has the broadest clinical development
programme of any PARP inhibitor, and AstraZeneca and MSD are
working together to deliver Lynparza as quickly as possible to more
patients across multiple settings, including breast, ovarian,
prostate and pancreatic cancers.
Sustainable and Ongoing Externalisation Revenue
Under the oncology collaboration with Merck, announced in July
2017, AstraZeneca is potentially eligible for more than $6 billion
of future Sustainable and Ongoing Externalisation Revenue in the
form of sales-related and approval-related payments in addition to
option payments until 2019. Following this new approval for
Lynparza, AstraZeneca will receive $70 million in Sustainable and
Ongoing Externalisation Revenue.
About OlympiAD
OlympiAD is a randomised, open-label, multicentre Phase III
trial assessing the efficacy and safety of Lynparza tablets (300 mg
twice daily) compared to physician's choice of chemotherapy in 302
patients with HER2-negative metastatic breast cancer with germline
BRCA1 or BRCA2 mutations, which are confirmed or suspected to be
deleterious. The international trial was conducted in 19 countries
across Europe, Asia, North America and South America.
Patients in the OlympiAD trial had HER2-negative gBRCA1- or
gBRCA2-mutated breast cancer, which was HR+ or triple negative, and
received Lynparza for metastatic disease. Approximately half of the
patients in the Lynparza and chemotherapy arm of the trial were HR+
(n=152), and approximately half were triple negative (n=150). Among
the 205 patients treated with Lynparza, the median age was 44 years
(range: 22 to 76). Before enrolment, patients had prior treatment
with an anthracycline (unless contraindicated) and a taxane
chemotherapy either in the neoadjuvant, adjuvant or metastatic
setting and no more than two prior lines of chemotherapy for
metastatic disease. Hormone receptor-positive patients had received
at least one endocrine medicine or were not eligible for endocrine
medicines. Prior treatments with endocrine medicines were not
counted as prior lines of chemotherapy.
The primary endpoint of the trial was PFS as measured by a
Blinded Independent Central Review. Secondary endpoints included
overall survival, time to second progression or death, objective
response rate, and effect on health-related quality of life.
About Metastatic Breast Cancer (MBC)
Three main receptors drive tumour growth in breast cancer:
progesterone receptors (PR), estrogen receptors (ER) and HER2
receptors. A patient's breast cancer will test either negative or
positive for these three receptors. If a tumour tests positive for
PR and/or ER, it is considered HR+. If a tumour tests negative for
all three receptors, it is considered triple negative.
MBC is the most advanced stage of breast cancer (Stage IV), and
occurs when cancer cells have spread beyond the initial tumour site
to other parts of the body outside of the breast.
Despite the increase in treatment options during the past three
decades, there is currently no cure for patients diagnosed with MBC
and only 26.9% of patients survive five years after diagnosis.
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.
It is estimated that in 2018, there will be approximately
155,000 women in the US living with MBC, and this number is
projected to increase to approximately 160,000 by the year
2020.
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 and cells become unstable. As a result, cells are
more likely to develop additional genetic alterations that can lead
to cancer.
About Lynparza (olaparib)
Lynparza is the first FDA-approved oral poly ADP-ribose
polymerase (PARP) inhibitor and the first targeted treatment to
potentially exploit DNA damage response (DDR) pathway deficiencies,
such as BRCA mutations, to preferentially kill cancer cells.
Specifically, in vitro studies have shown that Lynparza-induced
cytotoxicity may involve inhibition of PARP enzymatic activity and
increased formation of PARP-DNA complexes, resulting in DNA damage
and cancer cell death.
Lynparza is being investigated in a range of DDR-deficient
tumour types and is the foundation of AstraZeneca's
industry-leading portfolio of compounds 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. The collaboration is based on increasing
evidence that PARP and MEK inhibitors can be combined with
PD-L1/PD-1 inhibitors for a range of tumour types. Working
together, the companies will develop Lynparza and selumetinib in
combination with other potential new medicines and as a
monotherapy. 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 New 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, Tumour Drivers and Resistance, DNA Damage Response
and Antibody Drug Conjugates - and by championing the development
of personalized 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 & 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 Relations
Esra Erkal-Paler UK/Global +44 203 749 5638
Karen Birmingham UK/Global +44 203 749 5634
Rob Skelding UK/Global +44 203 749 5821
Matt Kent UK/Global +44 203 749 5906
Gonzalo Viña UK/Global +44 203 749 5916
Jacob Lund Sweden +46 8 553 260 20
Michele Meixell US +1 302 885 2677
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; Other +1 240 477 3771
Christer Gruvris Brilinta; Diabetes +44 203 749 5711
Nick Stone Respiratory; Renal +44 203 749 5716
US toll free +1 866 381 7277
Adrian Kemp
Company Secretary
AstraZeneca PLC
This information is provided by RNS
The company news service from the London Stock Exchange
END
MSCQLLFFVFFBBBZ
(END) Dow Jones Newswires
January 12, 2018 11:10 ET (16:10 GMT)
Astrazeneca (LSE:AZN)
Historical Stock Chart
From Mar 2024 to Apr 2024
Astrazeneca (LSE:AZN)
Historical Stock Chart
From Apr 2023 to Apr 2024