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 October
2019
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.
Trastuzumab deruxtecan granted FDA Priority Review for
treatment of patients with HER2-positive metastatic breast
cancer
17 Oct 2019 07:00 BST
Trastuzumab deruxtecan granted FDA Priority Review for
treatment of patients with HER2-positive metastatic breast
cancer
AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo)
today announced that the US Food and Drug Administration (FDA) has
accepted for review the Biologics License Application (BLA) for
[fam-] trastuzumab deruxtecan (DS-8201) and granted Priority
Review.
The Prescription Drug User Fee Act (PDUFA) date
for trastuzumab deruxtecan, a HER2-targeting antibody drug
conjugate (ADC) and potential new medicine for the treatment of
HER2-positive metastatic breast cancer, is set for the second
quarter of 2020.
José Baselga, Executive Vice President, Oncology R&D,
said: "Trastuzumab deruxtecan has the potential to transform
the treatment landscape for patients with HER2-positive metastatic
breast cancer who have limited treatment options
today. This
Priority Review draws on the strength and the consistency of
results seen in the Phase I and Phase II trials and is a critical
step on the journey to deliver this potential new medicine to
patients."
Antoine Yver, Executive Vice President and Global Head, Oncology
Research and Development, Daiichi Sankyo, said: "We are pleased
that the FDA has accepted the application and granted Priority
Review, as we believe trastuzumab deruxtecan has the potential to
redefine the treatment of patients with HER2-positive metastatic
breast cancer. Following the recent regulatory submission in Japan,
we look forward to working closely with regulatory authorities to
bring trastuzumab deruxtecan to patients in the US and Japan as
soon as possible."
Trastuzumab deruxtecan was previously granted US FDA Breakthrough
Therapy Designation and Fast Track designation. The BLA is
based on the combination of data from the Phase I trial published
in The
Lancet Oncology and
the pivotal Phase II DESTINY-Breast01 trial.1 The
response rate observed in DESTINY-Breast01, as assessed by an
independent review committee, validated the clinical activity
observed in the Phase I trial. Detailed data from DESTINY-Breast01
will be presented at the forthcoming San Antonio Breast Cancer
Symposium in December.
About HER2
HER2 is a tyrosine kinase receptor growth-promoting protein found
on the surface of some cancer cells that is associated with
aggressive disease and poorer prognosis in breast cancer
patients.2 To
be considered HER2-positive, tumour cancer cells are usually tested
by one of two methods: immunohistochemistry (IHC) or fluorescent in
situ hybridisation (FISH). IHC test results are reported as: 0, IHC
1+, IHC 2+, or IHC 3+2.A
finding of IHC 3+ and/or FISH amplification is considered
positive2.
About HER2-positive breast cancer
Approximately one in five breast cancers are
HER2-positive.3,4 Despite
recent improvements and approvals of new medicines, there remains
significant clinical needs for patients with advanced HER2-positive
metastatic breast cancer.5,6 This
disease remains incurable with patients eventually progressing
after available treatments.5,6 Additionally,
there are currently no approved HER2-targeted medicines for HER2
FISH negative, IHC 2+ or IHC 1+ tumours.
About DESTINY-Breast01
DESTINY-Breast01 is a pivotal Phase II, open-label, global,
multicentre, two-part trial evaluating the safety and efficacy of
trastuzumab deruxtecan in patients with HER2-positive unresectable
and/or metastatic breast cancer previously treated with trastuzumab
emtansine. The primary endpoint of the trial is objective response
rate, as determined by independent central review. Secondary
objectives include duration of response, disease control rate,
clinical benefit rate, progression-free survival and overall
survival. Enrolment into DESTINY-Breast01 was completed in
September 2018 with 253 patients at more than 100 sites across
North America, Europe, Japan and other countries in
Asia.
The safety and tolerability profile of trastuzumab deruxtecan in
DESTINY-Breast01 was consistent with the Phase I trial data
published in The
Lancet Oncology, in which the
most common adverse events (≥30 percent, any grade) included
nausea, decreased appetite, vomiting, alopecia, fatigue, anaemia,
diarrhoea and constipation. Cases of drug-related interstitial lung
disease and pneumonitis, including grade 5 events, have also been
reported in the clinical development programme.
About trastuzumab deruxtecan
Trastuzumab deruxtecan (DS-8201; [fam-] trastuzumab deruxtecan in
US only; trastuzumab deruxtecan in other regions of world) is the
lead product in the investigational ADC Franchise of the Daiichi
Sankyo Cancer Enterprise and the most advanced programme in
AstraZeneca's ADC scientific platform. ADCs are targeted cancer
medicines that deliver cytotoxic chemotherapy ("payload") to cancer
cells via a linker attached to a monoclonal antibody that binds to
a specific target expressed on cancer cells.
A comprehensive development programme is underway in North America,
Europe and Asia, including five pivotal trials in HER2-expressing
metastatic breast and gastric cancers, including a trial in
patients with metastatic breast cancer and low levels of HER2
expression. Phase II trials are underway for HER2-expressing
advanced colorectal cancer, as well as metastatic non-squamous
HER2-overexpressing or HER2-mutated non-small cell lung cancer.
Trials in combination with other anticancer treatments, such as
immunotherapy, are also underway.
Regulatory submission of trastuzumab deruxtecan was recently made
to Japan's Ministry of Health, Labour and Welfare (MHLW) for the
treatment of patients with HER2-positive metastatic breast cancer.
It also received SAKIGAKE designation for the treatment of advanced
HER2-positive gastric or gastroesophageal junction cancer by
Japan's MHLW.
About the collaboration between AstraZeneca and Daiichi
Sankyo
In March 2019, AstraZeneca and Daiichi Sankyo entered into a global
collaboration to jointly develop and commercialise trastuzumab
deruxtecan as a potential new medicine worldwide, except in Japan
where Daiichi Sankyo will maintain exclusive rights. Daiichi Sankyo
will be solely responsible for manufacturing and supply in
Japan.
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 investments 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, Cardiovascular, Renal and
Metabolism (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.
Media Relations
|
|
|
Gonzalo
Viña
|
|
+44 203 749 5916
|
Rob
Skelding
|
Oncology
|
+44 203 749 5821
|
Rebecca
Einhorn
|
Oncology
|
+1 301 518 4122
|
Matt
Kent
|
BioPharmaceuticals
|
+44 203 749 5906
|
Jennifer
Hursit
|
Other
|
+44 203 749 5762
|
Christina
Malmberg Hägerstrand
|
Sweden
|
+46 8 552 53 106
|
Michele
Meixell
|
US
|
+1 302 885 2677
|
|
|
|
Investor Relations
|
|
|
Thomas
Kudsk Larsen
|
|
+44 203 749 5712
|
Henry
Wheeler
|
Oncology
|
+44 203 749 5797
|
Christer
Gruvris
|
BioPharmaceuticals (CV, metabolism)
|
+44 203 749 5711
|
Nick
Stone
|
BioPharmaceuticals (respiratory, renal)
|
+44 203 749 5716
|
Josie
Afolabi
|
Other medicines
|
+44 203 749 5631
|
Craig
Marks
|
Finance, fixed income
|
+44 7881 615 764
|
Jennifer
Kretzmann
|
Corporate access, retail investors
|
+44 203 749 5824
|
US
toll-free
|
|
+1 866 381 72 77
|
References
1. Tamura, K, et al. Trastuzuamb deruxtecan (DS-8201a) in patients
with advanced HER2-positive breast cancer previously treated with
trastuzumab emtansine: a dose-expansion, phase 1
study. Lancet
Oncol.
2019;20(6):816-826.
2. American Cancer Society. Breast Cancer HER2 Status. Available
at https://www.cancer.org/cancer/breast-cancer/understanding-a-breast-cancer-diagnosis/breast-cancer-her2-status.html.
Accessed August 2019.
3.Tandon A, et al. HER-2/neu Oncogene Protein and Prognosis in
Breast Cancer. J Clin
Oncol.
1989;7(8):1120-8.
4. Sledge G, et al. Past, Present, and Future Challenges in
Breast Cancer Treatment. J Clin
Oncol.
2014;32(19):1979-1986.
5.de Melo Gagliato D, et al. Mechanisms of Resistance and Sensitivity to
Anti-HER2 Therapies in HER2+ Breast
Cancer. Oncotarget.
2016;7(39):64431-46.
6. National Comprehensive Cancer Network (NCCN). NCCN Guidelines.
Breast Cancer. Available at https://nccn.org.
Accessed August 2019.
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:
17 October
2019
|
By: /s/
Adrian Kemp
|
|
Name:
Adrian Kemp
|
|
Title:
Company Secretary
|