TIDMAZN
RNS Number : 0896H
AstraZeneca PLC
05 June 2017
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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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.
This information is provided by RNS
The company news service from the London Stock Exchange
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