TIDMAZN
RNS Number : 7882V
AstraZeneca PLC
05 December 2019
05 December 2019 07:00 GMT
Lynparza approved in China as a 1st-line maintenance
therapy in BRCA-mutated advanced ovarian cancer
AstraZeneca and MSD's Lynparza reduced the risk of disease
progression
or death by 70% in BRCAm advanced ovarian cancer after response
to 1st-
line platinum-based chemotherapy
Only PARP inhibitor approved in this setting in China
AstraZeneca and MSD Inc., Kenilworth, N.J., US (MSD: known as
Merck & Co., Inc. inside the US and Canada) today announced
that the companies have received marketing authorisation from
China's National Medical Products Administration (NMPA) for
Lynparza (olaparib) as a 1st-line maintenance treatment of adult
patients with newly diagnosed advanced germline or somatic BRCA
mutated (gBRCAm or sBRCAm) epithelial ovarian, fallopian tube or
primary peritoneal cancer who are in complete or partial response
to 1st-line platinum-based chemotherapy.
The approval in China is based on the results from the Phase III
SOLO-1 trial, which were published in The New England Journal of
Medicine. Results showed that Lynparza significantly reduced the
risk of disease progression or death by 70% (equal to a hazard
ratio of 0.30) vs. placebo in women with BRCAm advanced ovarian
cancer following response to platinum-based chemotherapy. Of those
women receiving Lynparza, 60% remained progression-free at three
years vs. 27% of women receiving placebo.
For newly diagnosed advanced ovarian cancer patients, the
primary aim of treatment is to delay progression of the disease for
as long as possible, with the intent of achieving complete
remission or cure. Of women diagnosed with ovarian cancer, 15% have
a germline (inherited) mutation and 7% have a somatic (acquired)
mutation in their BRCA1/2 genes.
Dave Fredrickson, Executive Vice President, Oncology Business
Unit, said: "This approval marks a new era for women with
BRCA-mutated advanced ovarian cancer in China, where the prevalence
of BRCA mutations in advanced disease is higher than the
international average. Currently, 70% of women relapse within three
years of initial treatment, representing the highest reoccurrence
rate among gynaecological cancers worldwide. The progression-free
survival benefit of Lynparza observed in SOLO-1 is a significant
step towards helping these women achieve long-term remission."
Roy Baynes, Senior Vice President and Head of Global Clinical
Development, Chief Medical Officer, MSD Research Laboratories,
said: "Today's approval of Lynparza reinforces the importance of
patients knowing their BRCA mutation status at diagnosis. We are
proud to provide a new option for the treatment of this devastating
disease in China, and we will continue to collaborate with the
Chinese government and healthcare organisations to provide Lynparza
to patients who need it as quickly as possible."
Lynparza is the first PARP inhibitor approved in China for
1st-line maintenance in BRCAm advanced ovarian cancer. AstraZeneca
and MSD are exploring additional trials in ovarian cancer and
recently announced positive results from the Phase III PAOLA-1
trial, which tested Lynparza in combination with bevacizumab as a
1st-line maintenance treatment for women with newly-diagnosed
advanced ovarian cancer, regardless of their biomarker status or
surgical outcome.
About SOLO-1
SOLO-1 was a Phase III, randomised, double-blinded,
placebo-controlled, multi-centre trial to evaluate the efficacy and
safety of Lynparza tablets (300mg twice daily) as a maintenance
monotherapy compared with placebo in patients with BRCAm advanced
ovarian cancer following 1st-line platinum-based chemotherapy. The
trial randomised 391 patients with a deleterious or suspected
deleterious germline or somatic BRCA1 or BRCA2 mutation who were in
clinical complete or partial response following platinum-based
chemotherapy.
Patients were randomised (2:1) to receive Lynparza or placebo
for up to two years or until disease progression. Patients who had
a partial response at two years were permitted to stay on therapy
at the investigator's discretion. The primary endpoint was
progression-free survival (PFS) and key secondary endpoints
included time to second disease progression or death, time to first
subsequent treatment and overall survival.
Summary of PFS(i,ii)
Lynparza (n=260) Placebo (n=131)
Number of patients with
event (%)(iii) 102 (39) 96 (73)
----------------- ----------------
Median PFS (in months) Not reached 13.8
----------------- ----------------
Hazard ratio (95% CI) 0.30 (0.23-0.41)
-----------------------------------
P-value p<0.001
-----------------------------------
(i Investigator-assessed.)
ii Median (interquartile range) duration of follow-up 40.7
months (34.9-42.9) for Lynparza and 41.2 months (32.2-41.6) for
placebo.
(iii Analysis was done at 50.6% maturity.)
The SOLO-1 safety profile was in line with that observed in
prior clinical trials, and with no detriment to quality of life.
The most common adverse events (AEs) >= 20% were nausea (77%),
fatigue (63%), vomiting (40%), anaemia (39%) and diarrhoea (34%).
The most common >= Grade 3 AEs were anaemia (22%) and
neutropenia (9%). Some 71% of patients on Lynparza remained on the
recommended starting dose. Additionally, 88% of patients on
Lynparza continued treatment without an AE-related
discontinuation.
The data were presented on 21 October 2018, at the Presidential
Symposium of the European Society of Medical Oncology (ESMO) 2018
Congress in Munich, Germany.
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) China has the highest
prevalence of ovarian cancer globally, with more than 52,000 new
cases diagnosed in 2018 and approximately 30,886 deaths.(1,2) Most
women are diagnosed with advanced (Stage III or IV) ovarian cancer
and have a five-year survival rate of approximately 30%.(3) Of
women diagnosed with ovarian cancer, 15% have a germline mutation
and 7% have a somatic mutation in their BRCA1/2 genes.(4,5) For
newly-diagnosed advanced ovarian cancer, the primary aim of
treatment is to delay progression of the disease for as long as
possible with the intent of achieving complete remission or
cure.(6,7,8,9)
About BRCA mutations
BRCA1 and BRCA2 (breast cancer susceptibility genes 1/2) 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 such as
breast and ovarian cancer.(10)
About Lynparza
Lynparza (olaparib) 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 (HRR), 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 65 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 44 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 advanced ovarian cancer and
metastatic breast cancer and has been used in 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 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 one of AstraZeneca's four
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 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 and
Metabolism, and Respiratory. AstraZeneca operates in over 100
countries and its innovative medicines are used by millions of
patients worldwide. Please visit astrazeneca.com and follow the
Company on Twitter @AstraZeneca.
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References
1. Worldovariancancercoalition.org. (2019). THE WORLD OVARIAN
CANCER COALITION ATLAS. Available at:
https://worldovariancancercoalition.org/wp-content/uploads/2018/10/THE-WORLD-OVARIAN-CANCER-COALITION-ATLAS-2018.pdf
[Accessed October 2019].
2. The World Health Organization. IARC. Globocan 2018. Available
at: http://gco.iarc.fr/ [Accessed August 2019].
3. National Cancer Institute. (2019). Cancer Stat Facts: Ovarian
Cancer Available at:
https://seer.cancer.gov/statfacts/html/ovary.html [Accessed August
2019].
4. Neff, R., Senter, L. and Salani, R. (2017). BRCA mutation in
ovarian cancer: testing, implications and treatment considerations.
Therapeutic Advances in Medical Oncology, 9(8), pp.519-531.
5. Bonadio, R., Fogace, R., Miranda, V. and Diz, M. (2018).
Homologous recombination deficiency in ovarian cancer: a review of
its epidemiology and management. Clinics, 73(Suppl 1).
6. Moore K et al. Maintenance Olaparib in Patients with Newly
Diagnosed Advanced Ovarian Cancer. resented at ESMO October 2018.
Available at https://www.ncbi.nlm.nih.gov/pubmed/30345884.
7. 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.
8. NHS Choices, Ovarian Cancer Available at:
https://www.nhs.uk/conditions/ovarian-cancer/treatment/ [Accessed
August 2019].
9. Ledermann.et al. 2013. Newly diagnosed and relapsed
epithelial ovarian carcinoma: ESMO Clinical Practice for diagnosis,
treatment and follow-up. Annals of Oncology, 24(suppl 6),
pp.vi24-vi32.
10. National Cancer Institute. (2018). BRCA Mutations: Cancer
Risk and Genetic Testing. Available at:
https://www.cancer.gov/about-cancer/causes-prevention/genetics/brca-fact-sheet
[Accessed October 2019].
Adrian Kemp
Company Secretary
AstraZeneca PLC
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