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2018-12-20

AstraZeneca: Lynparza meets primary endpoint in Phase III SOLO-3 trial for the treatment of relapsed BRCA-mutated advanced ...

AstraZeneca and MSD's Lynparza significantly improved objective
response rate compared to chemotherapy in platinum-sensitive relapsed
patients who had two or more prior lines of chemotherapy

AstraZeneca and Merck & Co., Inc., Kenilworth, N.J., US (Merck: known
as MSD outside the US and Canada) today announced positive results
from the randomised, open-label, controlled, Phase III SOLO-3 trial
of Lynparza (olaparib) tablets in 266 patients with relapsed ovarian
cancer after two or more lines of treatment. The trial was conducted
as a post-approval commitment in agreement with the US Food and Drug
Administration (FDA). This is the fourth Phase III trial to
demonstrate a positive result for Lynparza. AstraZeneca and MSD now
plan to discuss these results with the FDA.

Results from the trial showed BRCA-mutated (BRCAm) advanced ovarian
cancer patients treated with Lynparza following two or more prior
lines of chemotherapy demonstrated a statistically-significant and
clinically-meaningful improvement in the primary endpoint of
objective response rate (ORR) and the key secondary endpoint of
progression-free survival (PFS) compared to chemotherapy. The safety
and tolerability profile of Lynparza was consistent with previous
trials.

Sean Bohen, Executive Vice President, Global Medicines Development and
Chief Medical Officer, said: "We are very excited about SOLO-3, which
is the first Phase III trial for a PARP inhibitor to demonstrate a
positive result versus chemotherapy in advanced ovarian cancer where
effective options are needed. We look forward to sharing the full
results at a forthcoming medical meeting."

Roy Baynes, Senior Vice President and Head of Global Clinical
Development, Chief Medical Officer, MSD Research Laboratories, said:
"Following on the US approval of Lynparza as first-line maintenance
therapy for certain patients with BRCAm advanced ovarian cancer, the
results of SOLO-3 further reinforce the efficacy of Lynparza in
relapsed patients with gBRCAm advanced ovarian cancer following
multiple lines of chemotherapy."

About SOLO-3

SOLO-3 is a Phase III randomised, open-label, controlled, multicentre
trial to evaluate the efficacy and safety of Lynparza tablets
following two or more prior lines of chemotherapy. The trial
randomised 266 patients with a deleterious or suspected deleterious
BRCA1 or BRCA2 mutation. Eligible patients were randomised (2:1) to
receive Lynparza 300mg tablets twice daily or physician's choice
single-agent chemotherapy (paclitaxel, topotecan, pegylated liposomal
doxorubicin or gemcitabine). The primary endpoint was ORR by blinded
independent central review and key secondary endpoints included
progression-free survival, time to second disease progression or
death and overall survival.

About Lynparza

Lynparza is a first-in-class 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. Inhibition of PARP with Lynparza leads to the trapping of PARP
bound to DNA single-strand breaks, stalling of replication forks,
their collapse and the generation of DNA double-strand breaks and
cancer cell death. Lynparza is being tested in a range of tumour
types with defects and dependencies in the DDR.

Lynparza, which is being jointly developed and commercialised by
AstraZeneca and MSD, is approved for advanced ovarian cancer and
metastatic breast cancer and has been used in over 20,000 patients
worldwide. Lynparza has the broadest and most advanced clinical trial
development programme of any PARP inhibitor and AstraZeneca and MSD
are working together to understand how it may affect multiple
PARP-dependent tumours as a monotherapy and in combination across
multiple cancer types. Lynparza is the foundation of AstraZeneca's
industry-leading portfolio of potential new medicines targeting DDR
mechanisms in cancer cells.

About ovarian cancer

Ovarian cancer is a leading cause of cancer death in women worldwide,
with a five-year survival rate of 19%.[i]
(http://file:///C:/Users/kdzn235/AppData/Local/Microsoft/Windows/INetCach...)
In 2018, there were over 295,000 new cases diagnosed and around
185,000 deaths.[ii]
(http://file:///C:/Users/kdzn235/AppData/Local/Microsoft/Windows/INetCach...)
For newly-diagnosed advanced ovarian cancer, the primary aim of
treatment is to delay progression of the disease for as long as
possible and maintain the patient's quality of life with the intent
of achieving complete remission or cure.[iii]
(http://file:///C:/Users/kdzn235/AppData/Local/Microsoft/Windows/INetCach...),[iv]
(http://file:///C:/Users/kdzn235/AppData/Local/Microsoft/Windows/INetCach...),[v]
(http://file:///C:/Users/kdzn235/AppData/Local/Microsoft/Windows/INetCach...),[vi]
(http://file:///C:/Users/kdzn235/AppData/Local/Microsoft/Windows/INetCach...)

About 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 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 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. Working
together, the companies will develop Lynparza and selumetinib in
combination with other potential new medicines and as monotherapies.
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 Oncology as a key growth driver for AstraZeneca
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
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 therapy areas - Oncology, Cardiovascular, Renal & Metabolism
and Respiratory. 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
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
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Investor Relations
Thomas Kudsk Larsen +44 203 749 5712
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US toll-free +1 866 381 7277

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[i]
(http://file:///C:/Users/kdzn235/AppData/Local/Microsoft/Windows/INetCach...)
American Cancer Society. Survival Rates for Ovarian Cancer, by Stage.
Available at:
https://www.cancer.org/cancer/ovarian-cancer/detection-diagnosis-staging....
Accessed: October 2018

[ii]
(http://file:///C:/Users/kdzn235/AppData/Local/Microsoft/Windows/INetCach...)
Globocan 2018 http://gco.iarc.fr/

[iii]
(http://file:///C:/Users/kdzn235/AppData/Local/Microsoft/Windows/INetCach...)
Moore K et al. Maintenance Olaparib in Patients with Newly Diagnosed
Advanced Ovarian Cancer. Presented at ESMO October 2018

[iv]
(http://file:///C:/Users/kdzn235/AppData/Local/Microsoft/Windows/INetCach...)
Raja, F. A., Chopra, N. & Ledermann, J. A. Optimal first-line
treatment in ovarian cancer. Ann. Oncol. Off. J. Eur. Soc. Med.
Oncol. 23 Suppl 10, x118-127 (2012

[v]
(http://file:///C:/Users/kdzn235/AppData/Local/Microsoft/Windows/INetCach...)
NHS Choices, Ovarian Cancer Accessed
https://www.nhs.uk/conditions/ovarian-cancer/treatment/ in September
2018

[vi]
(http://file:///C:/Users/kdzn235/AppData/Local/Microsoft/Windows/INetCach...)
Ledermann.et al. 2013. Newly diagnosed and relapsed epithelial
ovarian carcinoma: ESMO Clinical Practice.

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