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2017-06-04

AstraZeneca: Lynparza significantly reduces the risk of disease worsening or death in patients with BRCA-mutated metastatic...

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]
(http://file:///C:/Users/kdzn235/AppData/Local/Microsoft/Windows/Temporar...)
Additionally, the trial was designated for the "Best of ASCO"
selection, underscoring the importance of these results for patients
and physicians.

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).

- ENDS -

NOTES TO EDITORS

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.[ii]
(http://file:///C:/Users/kdzn235/AppData/Local/Microsoft/Windows/Temporar...)
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.[iii]
(http://file:///C:/Users/kdzn235/AppData/Local/Microsoft/Windows/Temporar...)

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.[iv]
(http://file:///C:/Users/kdzn235/AppData/Local/Microsoft/Windows/Temporar...)
Of these patients, approximately one third are either diagnosed with,
or progress to, the metastatic stage of the disease.[v]
(http://file:///C:/Users/kdzn235/AppData/Local/Microsoft/Windows/Temporar...)
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.[vi]
(http://file:///C:/Users/kdzn235/AppData/Local/Microsoft/Windows/Temporar...)

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[vii]
(http://file:///C:/Users/kdzn235/AppData/Local/Microsoft/Windows/Temporar...)
and about 5 to 10% of all breast cancers[viii]
(http://file:///C:/Users/kdzn235/AppData/Local/Microsoft/Windows/Temporar...).
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.

Media Relations
Esra Erkal-Paler UK/Global +44 7771 740311
Karen Birmingham UK/Global +44 203 749 5634
Rob Skelding UK/Global +44 203 749 5821
Jacob Lund Sweden +46 8 553 260 20
Michele Meixell US +1 302 885 2677
Investor Relations
Thomas Kudsk Larsen +44 20...

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