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 August 2022
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
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United
Kingdom
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
Enhertu improved PFS in mBC in DESTINY-Breast02
15 August 2022 07:00 BST
Enhertu significantly
delayed disease progression in DESTINY-Breast02
Phase III trial vs. physician's choice of treatment in patients
with HER2-positive metastatic breast cancer
Results consistent with previous trials, reinforcing benefit of
AstraZeneca and Daiichi Sankyo's Enhertu in
previously treated patients
Positive high-level results from the DESTINY-Breast02 Phase III
trial of Enhertu (trastuzumab deruxtecan) versus physician's
choice of treatment showed the trial met the primary endpoint,
demonstrating a statistically significant and clinically meaningful
improvement in progression-free survival (PFS) in patients with
HER2-positive unresectable and/or metastatic breast cancer
previously treated with trastuzumab emtansine (T-DM1). The trial
also met the key secondary endpoint of improved overall survival
(OS).
Enhertu is a specifically
engineered HER2-directed antibody drug conjugate (ADC) being
jointly developed and commercialised by AstraZeneca and Daiichi
Sankyo.
The trial evaluated a similar later-line patient population as the
single-arm DESTINY-Breast01 Phase II trial, which was the basis for
initial approvals in advanced HER2-positive metastatic breast
cancer. The safety profile of Enhertu in DESTINY-Breast02 was consistent with
previous Phase III clinical trials with no new safety concerns
identified. Interstitial lung disease (ILD) rates and severity were
consistent with those observed in other metastatic breast cancer
trials of Enhertu, with a low rate of Grade 5 ILD events
observed as determined by an independent
adjudication committee.
Susan Galbraith, Executive Vice President, Oncology R&D,
AstraZeneca, said, "The DESTINY-Breast02 trial results in this
patient population with advanced disease confirm the efficacy and
safety profile seen in DESTINY-Breast01 and are consistent with the
results seen across our broader clinical programme in HER2-positive
metastatic breast cancer. These data further strengthen our
confidence in Enhertu and reinforce its potential to transform
patient outcomes across multiple treatment
settings."
Ken Takeshita, Global Head, R&D, Daiichi Sankyo, said: "The
top-line results from DESTINY-Breast02 confirm the robust
progression-free survival seen in previous trials
of Enhertu and enrich our clinical understanding of the
benefit this therapy may offer patients with
HER2-positive metastatic breast cancer. As this is the confirmatory
trial for our current breast cancer indication in Europe and
several other countries, we look forward to sharing these findings
with regulatory authorities to add to the body of data
for Enhertu for the treatment of HER2-positive
metastatic breast cancer."
The data will be presented at a forthcoming medical
meeting.
Notes
HER2-positive breast cancer
Breast cancer is the most common cancer and is one of the leading
causes of cancer-related deaths worldwide.1 More
than two million patients were diagnosed with breast cancer in
2020, with nearly 685,000 deaths globally.1 Approximately
one in five patients with breast cancer are considered
HER2-positive.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.3 HER2
protein overexpression may occur as a result of HER2 gene
amplification and is often associated with aggressive disease and
poor prognosis in breast cancer.4
DESTINY-Breast02
DESTINY-Breast02 is a global, randomised, open-label, Phase III
trial evaluating the efficacy and safety
of Enhertu (5.4mg/kg)
versus physician's choice of treatment (trastuzumab/capecitabine or
lapatinib/capecitabine) in patients with HER2-positive unresectable
and/or metastatic breast cancer previously treated with T-DM1.
Patients were randomised 2:1 to receive
either Enhertu or physician's choice of
treatment.
The primary endpoint of DESTINY-Breast02 is PFS based on blinded
independent central review (BICR). The key secondary endpoint is
OS. Other secondary endpoints include objective response rate based
on BICR and investigator assessment, duration of response based on
BICR, PFS based on investigator assessment and safety.
DESTINY-Breast02 enrolled approximately 600 patients at multiple
sites in Asia, Oceania, Europe, North America and South America.
For more information about the trial,
visit ClinicalTrials.gov.
Enhertu
Enhertu is a HER2-directed
ADC. Designed using Daiichi Sankyo's proprietary DXd ADC
technology, Enhertu is the lead ADC in the oncology portfolio of
Daiichi Sankyo and the most advanced programme in AstraZeneca's ADC
scientific platform. Enhertu consists of a HER2 monoclonal antibody
attached to a topoisomerase I inhibitor payload, an exatecan
derivative, via a stable tetrapeptide-based cleavable
linker.
Enhertu (5.4mg/kg) is
approved in more than 30 countries for the treatment of adult
patients with unresectable or metastatic HER2-positive breast
cancer who have received a (or one or more) prior anti-HER2-based
regimen either in the metastatic setting, or in the neoadjuvant or
adjuvant setting and have developed disease recurrence during or
within six months of completing therapy based on the results from
the DESTINY-Breast03 trial.
Enhertu (5.4mg/kg) is
approved in several countries 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 based on
the results from the DESTINY-Breast01 trial.
Enhertu (5.4mg/kg) is
approved in the US for the treatment of adult patients with
unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast
cancer who have received a prior chemotherapy in the metastatic
setting or developed disease recurrence during or within six months
of completing adjuvant chemotherapy based on the results from the
DESTINY-Breast04 trial.
Enhertu (5.4mg/kg) is
approved in the US for the treatment of adult patients with
unresectable or metastatic non-small cell lung cancer (NSCLC) whose
tumours have activating HER2 (ERBB2) mutations, as detected by a
Food and Drug Administration (FDA)-approved test, and who have
received a prior systemic therapy based on the results from the
DESTINY-Lung02 trial.
Enhertu (6.4mg/kg) is
approved in several countries for the treatment of adult patients
with locally advanced or metastatic HER2-positive gastric or
gastroesophageal junction (GEJ) adenocarcinoma who have received a
prior trastuzumab-based regimen based on the results from the
DESTINY-Gastric01 trial.
Enhertu development
programme
A comprehensive development programme is underway globally,
evaluating the efficacy and safety of Enhertu monotherapy across multiple HER2-targetable
cancers, including breast, gastric, lung and colorectal cancers.
Trials in combination with other anticancer treatments, such as
immunotherapy, are also underway.
Regulatory applications for Enhertu in breast and gastric cancer are currently
under review in several countries based on the DESTINY-Breast01,
DESTINY-Breast03, DESTINY-Breast04, DESTINY-Gastric01 and
DESTINY-Gastric02 trials, respectively.
Daiichi Sankyo collaboration
Daiichi Sankyo Company, Limited (TSE: 4568) [referred to
as Daiichi Sankyo] and AstraZeneca entered into a global
collaboration to jointly develop and
commercialise Enhertu (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 the manufacturing and supply
of Enhertu and datopotamab
deruxtecan.
AstraZeneca in breast cancer
Driven by a growing understanding of breast cancer biology,
AstraZeneca is challenging and redefining 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 oral
selective oestrogen receptor degrader (SERD) and potential new
medicine camizestrant.
PARP inhibitor Lynparza (olaparib) is a targeted treatment option
that has been studied in HER2-negative early and 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.
Building on the initial approvals of Enhertu, in previously treated HER2-positive metastatic
breast cancer, AstraZeneca and Daiichi Sankyo are exploring its
potential use 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 Imfinzi (durvalumab) in
combination with other oncology medicines,
including Lynparza and Enhertu, evaluating 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.
AstraZeneca in oncology
AstraZeneca is leading a revolution in oncology with the ambition
to provide cures for cancer in every form, following the science to
understand cancer and all its complexities to discover, develop and
deliver life-changing medicines to patients.
The Company's focus is on some of the most challenging cancers. It
is through persistent innovation that AstraZeneca has built one of
the most diverse portfolios and pipelines in the industry, with the
potential to catalyse changes in the practice of medicine and
transform the patient experience.
AstraZeneca has the vision to redefine cancer care 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 in
Oncology, Rare Diseases, and BioPharmaceuticals, including
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. Sung H, et al. Global Cancer
Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality
Worldwide for 36 Cancers in 185 Countries. CA Cancer J
Clin. 2021;
10.3322/caac.21660.
2. Ahn S, et al. HER2 status in breast
cancer: changes in guidelines and complicating factors for
interpretation. J Pathol Transl
Med. 2020; 54(1):
34-44.
3. Iqbal N, et al. Human Epidermal
Growth Factor Receptor 2 (HER2) in Cancers: Overexpression and
Therapeutic Implications. Mol Biol
Int. 2014;
852748.
4. Pillai R, et al. HER2 mutations in
lung adenocarcinomas: A report from the Lung Cancer Mutation
Consortium. Cancer. 2017; 1; 123(21): 4099-4105.
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:
15 August 2022
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By: /s/
Adrian Kemp
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Name:
Adrian Kemp
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Title:
Company Secretary
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