Blueprint
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 January 2018
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
Indicate
by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F.
Form
20-F X Form 40-F __
Indicate
by check mark if the registrant is submitting the Form 6-K in paper
as permitted by Regulation S-T Rule 101(b)(1):
Indicate
by check mark if the registrant is submitting the Form 6-K in paper
as permitted by Regulation S-T Rule 101(b)(7): ______
Indicate
by check mark whether the registrant by furnishing the information
contained in this Form is also thereby furnishing the information
to the Commission pursuant to Rule 12g3-2(b) under the Securities
Exchange Act of 1934.
Yes __
No X
If
“Yes” is marked, indicate below the file number
assigned to the Registrant in connection with Rule 12g3-2(b):
82-_____________
AstraZeneca PLC
INDEX
TO EXHIBITS
LYNPARZA
APPROVED IN JAPAN FOR OVARIAN CANCER
19 January 2018 07:00 GMT
LYNPARZA RECEIVES APPROVAL
IN JAPAN FOR THE TREATMENT OF ADVANCED OVARIAN CANCER
Lynparza is the first PARP inhibitor approved in Japan
Lynparza tablets approved as maintenance treatment for women with
platinum-sensitive relapsed ovarian cancer regardless of BRCA
mutation status
AstraZeneca
and Merck & Co., Inc., Kenilworth, NJ, US (known as MSD outside
the US and Canada) today announced that the Japanese Ministry of
Health, Labour and Welfare has approved Lynparza (olaparib) tablets (300mg
twice daily) for use as a maintenance therapy for patients with
platinum-sensitive relapsed ovarian cancer, regardless of their
BRCA mutation status, who
responded to their last platinum-based chemotherapy. Lynparza is the first poly ADP-ribose
polymerase (PARP) inhibitor to be approved in Japan.
Dave
Fredrickson, Executive Vice President, Head of the Oncology
Business Unit at AstraZeneca, said: "We are proud to bring this
important first-in-class treatment to women with platinum-sensitive
relapsed ovarian cancer in Japan who currently have very few
treatment options. The trials show that with Lynparza maintenance therapy, women
with ovarian cancer can live longer without their disease worsening
and Lynparza is well
tolerated."
Roy
Baynes, Senior Vice President and Head of Global Clinical
Development, Chief Medical Officer, MSD Research Laboratories,
said: "Today's decision is significant for Lynparza and, more importantly, for
Japanese patients living with advanced ovarian cancer. Our global
collaboration with AstraZeneca reinforces how our joint efforts can
advance science for patients, and we look forward to working
together to explore the potential of Lynparza across multiple tumour
types."
The
approval was granted on the basis of two randomised trials of
Lynparza maintenance
therapy for platinum-sensitive relapsed ovarian cancer, SOLO-2 and
Study 19.
Table 1. Summary of key efficacy results from randomised
trials:
|
Analysis
|
Reduction in the risk of disease progression or death
(PFS)
|
Reduction in the risk of death (OS)
|
|
SOLO-2
[gBRCAm]
n=295
|
Lynparza
|
70% (HR 0.30 [95% CI, 0.22-0.41], P<0.0001; median 19.1
vs 5.5 months by investigator-assessed analysis)
|
Data not yet mature
|
|
Placebo
|
|
Study 19
[PSR OC*]
n=265
|
Lynparza
|
65% (HR 0.35 [95% CI, 0.25-0.49], P<0.0001;
median
8.4 vs 4.8 months)
|
27% (HR 0.73 [95% CI, 0.55-0.95];
median
29.8 vs 27.8 months)
|
|
Placebo
|
*PSR =
Platinum-sensitive recurrent ovarian cancer
In
SOLO-2, the most common adverse drug reactions (≥20%) of any
grade reported in patients in the Lynparza arm were nausea (66.7%),
anaemia (39.0%), fatigue (29.7%), vomiting (25.6%), asthenia
(24.1%) and dysgeusia (23.1%).
In
Study 19, the most common adverse drug reactions (≥20%) of
any grade reported in patients in the Lynparza arm were nausea (64.0%),
fatigue (43.4%) and vomiting (21.3%).
Lynparza is also currently under review for use in
unresectable or recurrent BRCA-mutated, HER2-negative breast
cancer in Japan, with a decision expected in the second half of
2018 based upon a priority review.
About Ovarian Cancer in Japan
Worldwide,
ovarian cancer is the seventh most-commonly diagnosed cancer and
the eighth most-common cause of cancer deaths in women. In Japan,
more than 9,000 women are diagnosed with ovarian cancer every year
and the five-year survival rate is 58%, the lowest among all
gynaecological cancers. In 2012, 4,758 women with ovarian cancer
died, which represents one out of every two patients. As there is
no cure for relapsed ovarian cancer, the primary aim of treatment
is to slow progression of the disease for as long as possible and
improving or maintaining a patient's quality of life.
About SOLO-2
SOLO-2
was a Phase III, randomised, double-blinded, multicentre trial
designed to determine the efficacy of Lynparza tablets as a maintenance
monotherapy compared with placebo, in patients with
platinum-sensitive, relapsed or recurrent gBRCA-mutated ovarian, fallopian tube
and primary peritoneal cancer. The trial, conducted in
collaboration with the European Network for Gynaecological
Oncological Trial Groups (ENGOT) and Groupe d'Investigateurs
National pour l'Etude des Cancers de l'Ovaire et du sein (GINECO),
randomised 295 patients with documented germline BRCA1 or BRCA2 mutations who had received at
least two prior lines of platinum-based chemotherapy and were in
complete or partial response. Eligible patients were randomised to
receive 300mg Lynparza
tablets twice daily or placebo tablets twice daily.
About Study 19
Study
19 was a Phase II, randomised, double-blinded, placebo-controlled,
multicentre trial, which evaluated the efficacy and safety of
Lynparza compared with
placebo in relapsed, high-grade serous ovarian cancer patients. The
trial randomised 265 patients regardless of BRCA mutation status and who had
completed at least two courses of platinum-based chemotherapy and
their most recent treatment regimen. Eligible patients were
randomised to receive Lynparza maintenance monotherapy at a
dose of 400mg per day or matching placebo.
About Lynparza
(olaparib)
Lynparza is a first-in-class poly ADP-ribose polymerase
(PARP) inhibitor and the first targeted treatment to potentially
exploit tumour DNA damage response (DDR)-pathway deficiencies to
preferentially kill cancer cells. Specifically, in vitro studies
have shown that Lynparza-induced cytotoxicity may
involve inhibition of PARP enzymatic activity and increased
formation of PARP-DNA complexes, resulting in DNA damage and cancer
cell death.
Lynparza is being investigated in a range of DDR-deficient
tumour types and is the foundation of AstraZeneca's
industry-leading portfolio of compounds 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. The
collaboration is based on increasing evidence that PARP and MEK
inhibitors can be combined with PD-L1/PD-1 inhibitors for a range
of tumour types. Working together, the companies will develop
Lynparza and selumetinib in
combination with other potential new medicines and as a
monotherapy. 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 New 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, 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 & 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.
|
Media
Relations
|
|
|
|
Esra
Erkal-Paler
|
UK/Global
|
+44 203
749 5638
|
|
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
|
|
Jacob
Lund
|
Sweden
|
+46
8 553 260 20
|
|
Michele
Meixell
|
US
|
+1 302
885 2677
|
|
|
|
|
|
Investor
Relations
|
|
|
|
Thomas
Kudsk Larsen
|
|
+44 203
749 5712
|
|
Craig
Marks
|
Finance,
Fixed Income, M&A
|
+44
7881 615 764
|
|
Henry
Wheeler
|
Oncology
|
+44 203
749 5797
|
|
Mitchell
Chan
|
Oncology;
Other
|
+1 240
477 3771
|
|
Christer
Gruvris
|
Brilinta; Diabetes
|
+44 203
749 5711
|
|
Nick
Stone
|
Respiratory;
Renal
|
+44 203
749 5716
|
|
US toll
free
|
|
+1 866
381 7277
|
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:
19 January 2018
|
|
By: /s/
Adrian Kemp
|
|
|
Name:
Adrian Kemp
|
|
|
Title:
Company Secretary
|