TIDMAZN
RNS Number : 9929I
AstraZeneca PLC
14 August 2019
14 August 2019 07:00 BST
Lynparza Phase III PAOLA-1 trial met primary endpoint as
1st-line maintenance treatment with bevacizumab for advanced
ovarian cancer
AstraZeneca and MSD's Lynparza, when added to standard-of-care
bevacizumab, significantly increased the time women lived without
disease progression
AstraZeneca and MSD Inc., Kenilworth, N.J., US (MSD: known as
Merck & Co., Inc. inside the US and Canada) today announced
positive results from the Phase III PAOLA-1 trial in women with
advanced ovarian cancer. The trial, in the 1st-line maintenance
setting, compared Lynparza (olaparib) added to standard-of-care
(SoC) bevacizumab vs. bevacizumab alone in women with or without
BRCA gene mutations.
The trial met its primary endpoint in the intent-to-treat*
population with a statistically-significant and
clinically-meaningful improvement in progression-free survival
(PFS), increasing the time women taking Lynparza plus bevacizumab
lived without disease progression or death vs. those taking
bevacizumab alone. The results, including biomarker sub-group
analyses, will be presented at a forthcoming medical meeting. The
safety and tolerability profiles observed in PAOLA-1 were generally
consistent with those known for each medicine. PAOLA-1 is the
second positive Phase III trial with Lynparza in 1st-line advanced
ovarian cancer.
Jose Baselga, Executive Vice President, Oncology R&D, said:
"The positive results from the PAOLA-1 trial demonstrate a clear
potential benefit of adding Lynparza to the standard-treatment
bevacizumab for women with advanced ovarian cancer. Following
positive results from the SOLO-1 trial for women with a BRCA gene
mutation, the PAOLA-1 trial marks yet another positive Phase III
trial for Lynparza as a 1st-line maintenance treatment for women
with advanced ovarian cancer. We look forward to discussing the
results with global health authorities as soon as possible."
Roy Baynes, Senior Vice President and Head of Global Clinical
Development, Chief Medical Officer, MSD Research Laboratories,
said: "The Phase III PAOLA-1 trial demonstrates MSD's and
AstraZeneca's continued commitment to improving clinical outcomes
for women with advanced ovarian cancer. In this co-operative group
trial sponsored by ARCAGY Research, maintenance treatment with
Lynparza when added to a standard-of-care treatment was evaluated
in an environment representative of real clinical practice. By
studying Lynparza in this broader patient population, we have
learned more about how it may help even more patients with advanced
ovarian cancer in the future."
Eric Pujade-Lauraine, Medical Director of ARCAGY Research, said:
"The PAOLA-1 trial is a positive example of the strength and
promise of academia-industry collaboration in advancing science and
new treatment options for patients. We greatly appreciate the
commitment of AstraZeneca and MSD in working with academic
cooperative groups in ENGOT and look forward to sharing the full
PAOLA-1 results at a forthcoming medical meeting."
PAOLA-1 is an ENGOT (European Network of Gynaecological
Oncological Trial groups) trial, sponsored by ARCAGY Research
(Association de Recherche sur les CAncers dont GYnécologiques) on
behalf of GINECO (Groupe d'Investigateurs National des Etudes des
Cancers Ovariens et du sein). ARCAGY-GINECO is an academic group
specialising in clinical and translational research in patients'
cancers and a member of the GCIG (Gynecologic Cancer
InterGroup).
About PAOLA-1
PAOLA-1 is a randomised, double-blind Phase III trial testing
the efficacy and safety of Lynparza added to SoC bevacizumab vs.
bevacizumab alone, as a 1st-line maintenance treatment for
newly-diagnosed advanced FIGO Stage III-IV high grade serous or
endometroid ovarian, fallopian tube, or peritoneal cancer patients
who had a complete or partial response to 1st-line treatment with
platinum-based chemotherapy and bevacizumab. The intent-to-treat*
population refers to all patients randomised in the trial.
About ovarian cancer
Ovarian cancer is the eighth most common cause of death from
cancer in women worldwide. In 2018, there were nearly 300,000 new
cases diagnosed and around 185,000 deaths.(1) Most women are
diagnosed with advanced (Stage III or IV) ovarian cancer and have a
five-year survival rate of approximately 30%.(2) 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.(3,4,5,6)
About Lynparza
Lynparza is a first-in-class PARP inhibitor and the first
targeted treatment to block DNA damage response (DDR) in
cells/tumours harbouring a deficiency in homologous recombination
repair, such as mutations in BRCA1 and/or BRCA2. 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 PARP-dependent tumour
types with defects and dependencies in the DDR pathway.
Lynparza is currently approved in 64 countries, including those
in the EU, for the maintenance treatment of platinum-sensitive
relapsed ovarian cancer, regardless of BRCA status. It is approved
in the US, the EU, Japan and several other countries as 1st-line
maintenance treatment of BRCA-mutated advanced ovarian cancer
following response to platinum-based chemotherapy. It is also
approved in 43 countries, including the US and Japan, for germline
BRCA-mutated, HER2-negative, metastatic breast cancer, previously
treated with chemotherapy; in the EU, this includes
locally-advanced breast cancer. Regulatory reviews are underway in
other jurisdictions for ovarian, breast and pancreatic cancers.
Lynparza, which is being jointly developed and commercialised by
AstraZeneca and MSD, is approved for the treatment of advanced
ovarian cancer and metastatic breast cancer and has been used to
treat over 25,000 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 GINECO
GINECO (Groupe d'Investigateurs National des Etudes des Cancers
Ovariens et du sein) is the French Cooperative Group in Oncology
labelled by INCA (Institut National du Cancer, or French NCI)
developing and conducting gynaecological and metastatic breast
cancer clinical trials at the national and international level.
Founded in 1993, the GINECO group is a member of international
consortia such as ENGOT and GCIG.
About ENGOT
ENGOT (European Network for Gynaecological Oncological Trial
groups) is a research network of the European Society of
Gynaecological Oncology (ESGO). Founded in 2007, ENGOT includes 21
cooperative groups from 25 European countries.
About GCIG
The GCIG (Gynecological Cancer InterGroup) aims to promote and
facilitate high quality clinical trials in order to improve
outcomes for women with gynaecological cancer. Founded in 1998,
GCIG includes 23 cooperative groups from 28 countries
worldwide.
About the AstraZeneca and MSD strategic oncology
collaboration
In July 2017, AstraZeneca and Merck & Co., Inc., Kenilworth,
NJ, US, known as MSD outside the US 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, the Company is
committed to advance oncology as a key growth driver for
AstraZeneca focused on lung, ovarian, breast and blood cancers. In
addition to AstraZeneca's main capabilities, the Company is
actively pursuing innovative partnerships and investment that
accelerate the delivery of our strategy, as illustrated by the
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, CVRM and Respiratory. AstraZeneca
operates in over 100 countries and its innovative medicines are
used by millions of patients worldwide. For more information,
please visit astrazeneca.com and follow us on Twitter
@AstraZeneca.
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References
1. The World Health Organization. IARC. Globocan 2018. Available
at: http://gco.iarc.fr/. [Accessed July 2019].
2. National Cancer Institute. (2019). Cancer Stat Facts: Ovarian
Cancer Available at:
https://seer.cancer.gov/statfacts/html/ovary.html [Accessed August
2019].
3. Moore K et al. Maintenance Olaparib in Patients with Newly
Diagnosed Advanced Ovarian Cancer. Presented at ESMO October
2018.
4. Raja, F. A., Chopra, N. & Ledermann, J. A. 2012. Optimal
first-line treatment in ovarian cancer. Ann. Oncol. Off. J. Eur.
Soc. Med. Oncol. 23 Suppl 10, x118-127.
5. NHS Choices, Ovarian Cancer Available at:
https://www.nhs.uk/conditions/ovarian-cancer/treatment/ Accessed
July 2019].
6. Ledermann.et al. 2013. Newly diagnosed and relapsed
epithelial ovarian carcinoma: ESMO Clinical Practice.
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END
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