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 December 2020
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
Trastuzumab deruxtecan positive CHMP
14 December 2020 07:05 GMT
Trastuzumab deruxtecan recommended for approval in the
EU by CHMP for HER2-positive metastatic breast cancer
Recommendation based on positive results from the DESTINY-Breast01
trial,
which showed durable responses in patients with previously treated
disease
AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo)'s
trastuzumab deruxtecan has been recommended for conditional
marketing authorisation in the European Union (EU) as a monotherapy
for the treatment of adult patients with unresectable or metastatic
HER2-positive breast cancer who have received two or more prior
anti-HER2 based regimens.
In Europe, approximately 520,000 cases of breast cancer in women
are diagnosed annually, with roughly one in five cases being HER2
positive.1-2 The
impact of the disease is significant, with breast cancer
responsible for more than 137,000 deaths per
year.1
Following review of the application under its accelerated
assessment procedure, the Committee for Medicinal Products for
Human Use (CHMP) of the European Medicines Agency (EMA) based its
positive opinion on results from the registrational
DESTINY-Breast01 Phase II trial, which were published
in The
New England Journal of Medicine, and
the results from the Phase I trial published
in The
Lancet Oncology.3,4 In
the DESTINY-Breast01 trial, trastuzumab deruxtecan demonstrated
clinically meaningful and durable activity in patients who had
received two or more prior anti-HER2 medicines.
An updated analysis from
DESTINY-Breast01 was
presented last week at
the 2020 San Antonio Breast Cancer Symposium, reinforcing the
durable efficacy and long-term safety and tolerability profiles of
trastuzumab deruxtecan.
José Baselga, Executive Vice President, Oncology R&D,
said: "The durable responses demonstrated in the DESTINY-Breast01
trial have never been seen before in this patient setting. If
approved by the European Commission, physicians in Europe will have
an important new treatment option for patients with previously
treated HER2-positive metastatic breast cancer."
Gilles Gallant, Senior Vice President, Global Head, Oncology
Development, Oncology R&D, Daiichi Sankyo, said: "We are
encouraged by the CHMP positive opinion given the significant unmet
need for patients with HER2-positive metastatic breast cancer.
Trastuzumab deruxtecan is already available for patients with
HER2-positive metastatic breast cancer in the US and Japan, and we
are now one step closer to bringing this important new medicine to
patients in Europe."
HER2-positive breast cancer
Approximately 520,000 cases of breast cancer are diagnosed in
Europe annually, with an estimated one in five cases considered
HER2 positive.1-2
HER2 is a tyrosine kinase receptor growth-promoting protein
expressed on the surface of many types of tumours, including
breast, gastric, lung and colorectal cancers. HER2 overexpression
may be associated with a specific HER2 gene alteration known as
HER2 amplification and is often associated with aggressive disease
and a poor prognosis in breast cancer.5
There remain significant unmet clinical needs for patients with
HER2-positive metastatic breast cancer. The disease remains
incurable with patients eventually progressing after currently
available treatment options.6,7
DESTINY-Breast01
DESTINY-Breast01 is a registrational Phase II, single-arm,
open-label, global, multicentre, two-part trial testing 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.
Trastuzumab deruxtecan
Trastuzumab deruxtecan is a HER2-directed antibody drug conjugate
(ADC). It is the lead ADC in the oncology portfolio of Daiichi
Sankyo 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. Trastuzumab deruxtecan is comprised of a HER2
monoclonal antibody attached to a topoisomerase I inhibitor payload
by a tetrapeptide-based linker.
Trastuzumab deruxtecan is approved under the brand
name Enhertu (5.4mg/kg) in the US and Japan for the
treatment of adult patients with unresectable or metastatic
HER2-positive breast cancer who have received two or more prior
anti-HER2-based regimens in the metastatic setting based on the
DESTINY-Breast01 trial. In September
2020, Enhertu (6.4mg/kg) was approved in Japan for
patients with HER2-positive unresectable advanced or recurrent
gastric cancer that progressed after chemotherapy based on the
DESTINY-Gastric01 trial.
Development programme
A comprehensive development programme is underway globally, with
nine registrational trials evaluating the efficacy and safety of
trastuzumab deruxtecan monotherapy across multiple HER2 cancers,
including breast, gastric and lung cancers. Trials in combination
with other anticancer treatments, such as immunotherapy, are also
underway.
In October 2020, trastuzumab deruxtecan was granted
Priority Review from the US Food and Drug Administration for the
treatment of patients with HER2-positive metastatic gastric or
gastroesophageal junction (GEJ) adenocarcinoma. In May
2020, trastuzumab deruxtecan received a Breakthrough
Therapy Designation (BTD) and Orphan Drug Designation (ODD) for
gastric cancer, including GEJ adenocarcinoma.
In May 2020, trastuzumab deruxtecan also received a BTD for the
treatment of patients with metastatic non-small cell lung cancer
whose tumours have a HER2 mutation and with disease progression on
or after platinum-based therapy.
Daiichi Sankyo collaboration
Daiichi Sankyo and AstraZeneca entered into a global collaboration
to jointly develop and commercialise trastuzumab deruxtecan (a
HER2-directed ADC) in March 2019, and datopotamab deruxtecan
(DS-1062; a TROP2-directed ADC) in July 2020, except in Japan where
Daiichi Sankyo maintains exclusive rights. Daiichi Sankyo is
responsible for manufacturing and supply of trastuzumab deruxtecan
and datopotamab deruxtecan.
AstraZeneca in breast cancer
Driven by a growing understanding of breast cancer biology,
AstraZeneca is starting to challenge, and redefine, the current
clinical paradigm for how breast cancer is classified and
treated to deliver even more effective treatments to patients
in need - with the bold ambition to one day eliminate breast cancer
as a cause of death.
AstraZeneca has a comprehensive portfolio of approved and promising
compounds in development that leverage different mechanisms of
action to address the biologically diverse breast cancer tumour
environment. AstraZeneca aims to continue to transform outcomes for
HR-positive breast cancer with foundational
medicines Faslodex (fulvestrant) and Zoladex (goserelin)
and the next-generation SERD and potential new medicine AZD9833.
PARP inhibitor, Lynparza (olaparib)
is a targeted treatment option for metastatic breast cancer
patients with an inherited BRCA mutation. AstraZeneca with MSD
(Merck & Co., Inc. in the US and Canada) continue to
research Lynparza in metastatic breast cancer patients with an
inherited BRCA mutation and are exploring new opportunities to
treat these patients earlier in their disease state. Building on
the first approval of Enhertu, a HER2-directed antibody-drug
conjugate, in previously treated HER2-positive
metastatic breast cancer, AstraZeneca and Daiichi Sankyo are
exploring its potential in earlier lines of treatment and in new
breast cancer settings. To bring much needed treatment options to
patients with triple-negative breast cancer, an aggressive form of
breast cancer, AstraZeneca is testing immunotherapy durvalumab in
combination with other oncology medicines,
including Lynparza and Enhertu, investigating the potential of AKT kinase
inhibitor, capivasertib, in combination with chemotherapy, and
collaborating with Daiichi Sankyo to explore the potential of
TROP2-directed ADC, datopotamab deruxtecan
(DS-1062).
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 six scientific platforms -
Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage
Response, Antibody Drug Conjugates, Epigenetics, and Cell Therapies
- 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.
GLOBALCAN
2018 Breast Cancer Fact Sheet. World Health Organization. Accessed:
December 2020.
2.
DeKoven M, et al. Treatment pattern by hormone
receptors and HER2 status in patients with metastatic breast cancer
in the UK, Germany, France, Spain and Italy (EU-5): results from a
physician survey. J Comp Eff
Res. 2012
Sep;1(5):453-63.
3.
Tamura, K, et al. Trastuzumab 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.
4.
Modi, S et al. Trastuzumab deruxtecan in
previously treated HER2-positive breast
cancer. N Engl J
Med. 2020; 382:610-621;
DOI: 10.1056/NEJMoa1914510.
5.
Iqbal N, et al. Human Epidermal Growth Factor
Receptor 2 (HER2) in cancers: Overexpression and therapeutic
implications. Mol Biol
Int.
2014;852748.
6.
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.
7.
National
Comprehensive Cancer Network (NCCN). NCCN Guidelines Version
3.2020. Breast Cancer. December 2020.
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:
14 December
2020
|
By: /s/
Adrian Kemp
|
|
Name:
Adrian Kemp
|
|
Title:
Company Secretary
|
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