FORM 6-K
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
Report
of Foreign Issuer
Pursuant
to Rule 13a-16 or 15d-16 of
the
Securities Exchange Act of 1934
For the
month of November 2020
Commission
File Number: 001-11960
AstraZeneca PLC
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
Lynparza approved in the EU as 1st-line maintenance
treatment with
bevacizumab for HRD-positive advanced ovarian cancer
5 November 2020 07:15
GMT
Lynparza approved
in the EU as 1st-line maintenance treatment
with bevacizumab for HRD-positive advanced ovarian
cancer
Patients treated with Lynparza and bevacizumab lived without
disease
progression for a median of 37.2 months vs. 17.7 months with
bevacizumab alone
One in two women with advanced ovarian cancer has an HRD-positive
tumour
AstraZeneca and MSD's Lynparza (olaparib) has been approved in the European
Union (EU) for the 1st-line maintenance treatment with bevacizumab
of patients with homologous recombination deficient (HRD)-positive
advanced ovarian cancer.
Ovarian cancer is the fifth most common cause of cancer death in
the EU and the five-year survival rate is approximately 45%, due
partly because women are often diagnosed with advanced disease
(Stage III or IV).1-3
The approval by the European Commission was based on a biomarker
subgroup analysis of the PAOLA-1 Phase III trial which
showed Lynparza, in combination with bevacizumab maintenance
treatment, demonstrated a substantial progression-free survival
(PFS) improvement versus bevacizumab alone for patients with
HRD-positive advanced ovarian cancer. It follows
the recommendation for
approval by the Committee
for Medicinal Products for Human Use of the European Medicines
Agency in September 2020.
Isabelle Ray-Coquard, principal investigator of the PAOLA-1 Phase
III trial and medical oncologist, Centre Léon Bérard and
President of the GINECO group, Paris, France, said: "For women with
advanced ovarian cancer, the goal of 1st-line treatment is to delay
disease progression for as long as possible with the intent of
achieving long-term remission. Unfortunately, once a patient's
cancer recurs, it historically has been
incurable. Lynparza together with bevacizumab has demonstrated
an impressive median progression-free survival benefit of more than
three years and is poised to become the standard of care for
eligible patients with HRD-positive tumours in the
EU."
Dave Fredrickson, Executive Vice President, Oncology Business Unit,
said: "Half of all newly diagnosed patients with advanced ovarian
cancer have HRD-positive tumours. Women treated
with Lynparza in combination with bevacizumab in the
PAOLA-1 Phase III trial lived progression free for a median of more
than three years, showing that HRD testing should be an essential
component of clinical diagnosis. HRD status can help physicians
select a personalised 1st-line treatment regimen for patients to
substantially delay relapse in this devastating
disease."
Roy Baynes, Senior Vice President and Head of Global Clinical
Development, Chief Medical Officer, MSD Research Laboratories,
said: "Biomarker testing has rapidly enhanced our understanding of
how PARP inhibition can help target this disease. The EU approval
reinforces that HRD-positive tumours represent a distinct subset of
advanced ovarian cancer and HRD testing is critical for women in
this setting."
The PAOLA-1 Phase III trial showed
that Lynparza, in combination with bevacizumab maintenance
treatment, reduced the risk of disease progression or death by 67%
(based on a hazard ratio of 0.33; 95% confidence interval
0.25-0.45). The addition of Lynparza improved PFS to a median of 37.2 months
versus 17.7 with bevacizumab alone in patients with HRD-positive
advanced ovarian cancer. The data from the PAOLA-1 trial was
published in The
New England Journal of Medicine in 2019.
Further results recently presented at the European Society for
Medical Oncology Virtual Congress 2020 showed a statistically
significant improvement in the key secondary endpoint of the time
to second disease progression (PFS2). Lynparza with bevacizumab provided benefit beyond
first disease progression, improving PFS2 to a median of 50.3
months versus 35.3 with bevacizumab alone.
The full EU indication is for Lynparza in combination with bevacizumab for the
maintenance treatment of adult patients with advanced (FIGO Stages
III and IV) high-grade epithelial ovarian, fallopian tube or
primary peritoneal cancer who are in response (complete or partial)
following completion of 1st-line platinum-based chemotherapy in
combination with bevacizumab and whose cancer is associated with
HRD positive status defined by either a breast cancer
susceptibility gene 1/2 (BRCA1/2) mutation and/or genomic
instability.
Lynparza in combination
with bevacizumab is approved in the
US and in several other
countries as a 1st-line maintenance treatment for patients with
HRD-positive advanced ovarian cancer and is currently under
regulatory review in other countries around the
world.
Financial considerations
Following this approval for Lynparza in
the EU, AstraZeneca will receive a regulatory milestone payment
from MSD of $25m, anticipated to be booked as collaboration revenue
during the fourth quarter of 2020.
Ovarian cancer
In 2018, there were nearly 68,000 new cases of ovarian cancer
diagnosed in the EU and around 45,000 deaths.3 Approximately
50% of ovarian cancers are HRD-positive including BRCA1/2
mutation.4,5 Approximately
15% of ovarian cancers have a BRCA1/2 mutation.6
The primary aim of 1st-line treatment is to delay disease
progression for as long as possible with the intent to achieve
long-term remission.7-9
Homologous recombination deficiency
HRD, which defines a subgroup of ovarian cancer, encompasses a wide
range of genetic abnormalities, including BRCA mutations and
beyond. As with BRCA gene mutations, HRD interferes with normal
cell DNA repair mechanisms and confers sensitivity to PARP
inhibitors including Lynparza.10
PAOLA-1
PAOLA-1 is a double-blinded Phase III trial testing the efficacy
and safety of Lynparza added to standard-of-care bevacizumab
versus 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. AstraZeneca and
MSD announced in August
2019 that the trial met
its primary endpoint of PFS in the overall trial
population.
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 a number of countries, including those in the EU, for
the maintenance treatment of platinum-sensitive relapsed ovarian
cancer. It is approved in the US, the EU, Japan, China, 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 the US as a 1st-line
maintenance treatment with bevacizumab for patients with
HRD-positive advanced ovarian cancer (BRCAm and/or genomic
instability). Lynparza is approved in the US, Japan, and a number
of other countries for germline BRCA-mutated, HER2-negative,
metastatic breast cancer, previously treated with chemotherapy; in
the EU, this includes locally advanced breast cancer. It is also
approved in the US, the EU and several other countries for the
treatment of germline BRCAm metastatic pancreatic
cancer. Lynparza is approved in the US for homologous
recombination repair (HRR) gene-mutated metastatic
castration-resistant prostate cancer (BRCAm and other HRR gene
mutations). Regulatory reviews are underway in several countries
for ovarian, breast, pancreatic and prostate
cancers.
Lynparza, which is being
jointly developed and commercialised by AstraZeneca and MSD, has
been used to treat over 30,000 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.
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 Koselugo (selumetinib), a mitogen-activated protein
kinase (MEK) inhibitor, for multiple cancer types. Working
together, the companies will develop Lynparza and Koselugo in combination with other potential new
medicines and as monotherapies. Independently, the companies will
develop Lynparza and Koselugo in combination with their respective PD-L1
and PD-1 medicines.
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 seven new medicines
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.
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.
AstraZeneca
AstraZeneca (LSE/STO/Nasdaq: AZN) 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 & Immunology. Based in Cambridge, UK, 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.
Contacts
For details on how to contact the Investor Relations Team, please
click here.
For Media contacts, click here.
References
1. EuroHealth. (2018). Ovarian Cancer: The Silent Killer. Available
at: https://eurohealth.ie/policy-brief-women-and-ovarian-cancer-in-the-eu-2018/ [Accessed
October 2020].
2. ECIS. (2020).Estimates of cancer incidence and mortality in
2020, for all cancer sites. Available here [Accessed
October 2020].
3. The World Health Organization. IARC. Globocan. (2018). Available
at: http://gco.iarc.fr/ [Accessed
October 2020].
4. Moschetta et al. (2016). BRCA somatic mutations and
epigenetic BRCA modifications in serous ovarian cancer. Annals of
Oncology, 27(8), pp.1449-1455.
5. Bonadio et al. (2018). Homologous recombination deficiency in
ovarian cancer: a review of its epidemiology and
management. Clinics, 73(Suppl 1): e450s.
6. Ramus. (2009). The Contribution of BRCA1 and BRCA2 to Ovarian
Cancer. Molecular Oncology, 3(2), pp.138-150.
7. Raja et al. (2012). Optimal first-line treatment in ovarian
cancer. Annals on Oncology. 23 Suppl 10, x118-127.
8. NHS Choices, Ovarian Cancer Available
at: https://www.nhs.uk/conditions/ovarian-cancer/treatment/ [Accessed
October 2020].
9. Ledermann et al. (2013). Newly diagnosed and relapsed epithelial
ovarian carcinoma: ESMO Clinical Practice Guidelines for diagnosis,
treatment and follow-up. Annals of Oncology, 24,
pp.vi24-vi32.
10. Moore, K. (2018). Maintenance Olaparib in Patients with Newly
Diagnosed Advanced Ovarian Cancer. New England Journal of Medicine,
379(26), pp.2495-2505.
Adrian Kemp
Company Secretary
AstraZeneca PLC
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorized.
Date:
05 November
2020
|
By: /s/
Adrian Kemp
|
|
Name:
Adrian Kemp
|
|
Title:
Company Secretary
|
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