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 April 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
1.
AZ AND MSD SUBMIT LYNPARZA FOR BREAST CANCER IN
EU
3 April 2018 07:00 GMT
THE EUROPEAN MEDICINES AGENCY ACCEPTS
REGULATORY SUBMISSION FOR LYNPARZA IN BRCA-MUTATED, HER2-NEGATIVE
METASTATIC
BREAST CANCER
If approved, AstraZeneca and MSD's Lynparza would be the first PARP
inhibitor to treat patients with breast cancer in
Europe
AstraZeneca and Merck & Co., Inc., Kenilworth, N.J., US (Merck:
known as MSD outside the US and Canada) today announced that
the European Medicines Agency has validated for review the
Marketing Authorisation
Application (MAA) for Lynparza (olaparib) for use in patients with
deleterious or suspected deleterious BRCA-mutated, human epidermal growth factor receptor 2
(HER2)-negative metastatic breast cancer who have been previously
treated with chemotherapy in the neoadjuvant, adjuvant or
metastatic setting.
This is the first regulatory submission for a poly ADP-ribose
polymerase (PARP) inhibitor in breast cancer in Europe. If
approved, the identification of a patient's BRCA status could become a critical step in the
management of their disease alongside current consideration of
their hormone receptor and HER2 status. The MAA includes data from
the randomised, open-label, Phase III OlympiAD
trial, which
investigated Lynparza versus chemotherapy (physician's choice of
capecitabine, eribulin or vinorelbine). In the trial,
Lynparza
significantly prolonged
progression-free survival compared with chemotherapy and reduced
the risk of disease progression or death by 42% (HR 0.58; 95% CI
0.43-0.80; P=0.0009 median 7.0 vs. 4.2 months).
In January 2018, Lynparza was approved by the US Food and Drug
Administration for use in the treatment of BRCA-mutated HER2-negative metastatic breast cancer,
becoming the first PARP inhibitor to be approved beyond ovarian
cancer. Lynparza is available in nearly 60 countries and has been
used to treat more than 20,000 patients. AstraZeneca and MSD are
working together to bring Lynparza to more patients across multiple
cancers.
About OlympiAD
OlympiAD is a global, randomised, open-label, multi-centre Phase
III trial of 302 patients, assessing the efficacy and safety
of Lynparza tablets (300 mg twice daily) compared to
physician's choice of chemotherapy. 205 patients were randomised to
receive Lynparza and 97 patients were randomised to receive
chemotherapy.
Patients in the OlympiAD trial had germline BRCA-mutated, HER2-negative (hormone receptor-positive
or triple negative) breast cancer and received Lynparza for treatment in the metastatic setting. Prior to
enrolment, 71% of patients had received no more than two previous
chemotherapy treatments for metastasised breast cancer and 28% of
patients had received prior platinum-based chemotherapy. Also
enrolled were patients with HR+ breast cancer who had received at
least one endocrine therapy (adjuvant therapy or therapy for
metastatic disease) and had disease progression during therapy
unless they had disease for which the endocrine therapy was
considered inappropriate.
About Metastatic Breast Cancer
Progesterone receptors (PR), estrogen receptors (ER) and HER2
receptors may be expressed on breast cancer cells. A patient's
breast cancer will test either negative or positive for these three
receptors. If a tumour tests positive for PR and/or ER, it is
considered HR+. If a tumour tests negative for all three receptors,
it is considered triple negative. These receptors indicate which
hormones or other proteins may be promoting growth of the
cancer.
Metastatic Breast Cancer (MBC) is the most advanced stage of breast
cancer (Stage IV), and occurs when cancer cells have spread beyond
the initial tumour site to other parts of the body, outside of the
breast and nearby lymph nodes.
Despite the increase in treatment options during the past three
decades, there is currently no cure for patients diagnosed with MBC
and only 26.9% of patients survive for five years after diagnosis.
Thus, the primary aim of treatment is to slow progression of the
disease for as long as possible, improving, or at least
maintaining, a patient's quality of life.
Breast cancer is the most common cancer in women, with an estimated
1.67 million new cases diagnosed worldwide in 2012 alone - one in
four of all cancer cases. Approximately 30% of women who are
diagnosed with early breast cancer will go on to develop advanced
disease.
About BRCA Mutations
BRCA1 and BRCA2 are human genes that produce proteins
responsible for repairing damaged DNA and play an important role
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 Lynparza
Lynparza was the 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.
Specifically, in vitro trials 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, which has the
broadest clinical development programme of any PARP inhibitor, 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 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 personalized 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. 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:
03 April
2018
|
|
By: /s/
Adrian Kemp
|
|
|
Name:
Adrian Kemp
|
|
|
Title:
Company Secretary
|