Form 6-K ASTRAZENECA PLC For: Jun 27
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 June 2022
Commission
File Number: 001-11960
AstraZeneca PLC
1
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Biomedical Campus
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United
Kingdom
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
Enhertu recommended for breast cancer EU approval
27 June 2022 07:05 BST
Enhertu recommended
for approval in the EU by CHMP for patients with HER2-positive
metastatic breast cancer treated with a prior anti-HER2-based
regimen
Recommendation based on DESTINY-Breast03 trial results showing
AstraZeneca and Daiichi Sankyo's Enhertu reduced the risk of
disease progression or death by 72% vs. trastuzumab emtansine
(T-DM1)
AstraZeneca and Daiichi Sankyo's Enhertu (trastuzumab deruxtecan) has been
recommended for approval 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 one or
more prior anti-HER2-based regimens.
Enhertu is a specifically
engineered HER2-directed antibody drug conjugate (ADC) being
jointly developed and commercialised by AstraZeneca and Daiichi
Sankyo.
The Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency (EMA) based its positive opinion on
results from the DESTINY-Breast03 Phase III trial, which were
published in The
New England Journal of Medicine.1 In
the trial, Enhertu reduced the risk of disease progression or
death by 72% versus trastuzumab emtansine (T-DM1) (hazard ratio
[HR] 0.28; 95% confidence interval [CI]: 0.22-0.37; p<0.0001) in
patients with HER2-positive unresectable and/or metastatic breast
cancer previously treated with trastuzumab and a
taxane.
In Europe, more than 530,000 cases of breast cancer are diagnosed
annually.2 Approximately
one in five cases of breast cancer are considered
HER2-positive.3 Despite
initial treatment with trastuzumab, pertuzumab and a taxane,
patients with HER2-positive metastatic breast cancer will often
experience disease progression.4,5 More
treatment options are needed to further delay progression and
extend survival.4,6,7
Susan Galbraith, Executive Vice President, Oncology R&D,
AstraZeneca, said: "This recommendation reflects the transformative
progression-free survival benefit seen in the
DESTINY-Breast03 trial compared to T-DM1,
supporting Enhertu as a potential new standard of care and
setting a new benchmark in the treatment of HER2-positive
metastatic breast cancer. If approved by the European
Commission, patients in Europe may be able to benefit from this
important medicine earlier in the treatment of their disease,
improving their chance for better outcomes."
Gilles Gallant, Senior Vice President, Global Head, Oncology
Development, Oncology R&D, Daiichi Sankyo, said: "Today's CHMP
opinion provides further validation of the significance of the
DESTINY-Breast03 trial results, which for the first time showed
superiority of Enhertu in prolonging progression-free survival in
patients previously treated for HER2-positive metastatic breast
cancer as compared to another HER2-directed ADC. This positive CHMP
opinion is an important step forward in bringing this potentially
practice-changing medicine to patients in Europe to use earlier in
the treatment of HER2-positive metastatic breast cancer and builds
on the recent approval of Enhertu in the US."
The recommendation will now be reviewed by the European Commission,
which has the authority to grant marketing authorisations for
medicines in the EU.
Enhertu is being further
assessed in a comprehensive clinical development programme
evaluating efficacy and safety across multiple HER2-targetable
cancers, including breast, gastric, lung and colorectal
cancers.
Notes
HER2-positive breast cancer
Breast cancer is the most common cancer and is one of the leading
causes of cancer-related deaths worldwide.8 More
than two million cases of breast cancer were diagnosed in 2020,
with nearly 685,000 deaths globally.8 In
Europe, more than 530,000 cases of breast cancer are diagnosed
annually.2 Approximately
one in five cases of breast cancer are considered
HER2-positive.3
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.9 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.10
Despite initial treatment with trastuzumab, pertuzumab and a
taxane, patients with HER2-positive metastatic breast cancer will
often experience disease progression.4.5 More
treatment options are needed to further delay progression and
extend survival.4,6,7
DESTINY-Breast03
DESTINY-Breast03 is a global, head-to-head, randomised, open-label,
registrational Phase III trial evaluating the efficacy and safety
of Enhertu (5.4 mg/kg) versus T-DM1 in patients with
HER2-positive unresectable and/or metastatic breast cancer
previously treated with trastuzumab and a
taxane.
The primary efficacy endpoint of DESTINY-Breast03 is
progression-free survival (PFS) based on blinded independent
central review. Secondary efficacy endpoints include overall
survival, objective response rate, duration of response, PFS based
on investigator assessment and safety.
DESTINY-Breast03 enrolled 524 patients at multiple sites in Asia,
Europe, North America, Oceania and South America. Results from
DESTINY-Breast03 have been published in The
New England Journal of Medicine.1 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 (5.4 mg/kg) is
approved in Canada, Israel and the US for the treatment of adult
patients with unresectable or metastatic HER2-positive breast
cancer who have received a 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 results from the DESTINY-Breast03
trial.
Enhertu (5.4mg/kg) is also
approved in approximately 40 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 (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 are currently under review in China, Europe,
Japan and several other countries for the treatment of adult
patients with unresectable or metastatic HER2-positive breast
cancer who have received a prior anti-HER2-based regimen based on
the results from the DESTINY-Breast03 trial.
Enhertu is
under review in Europe for
the treatment of adult
patients with unresectable or metastatic
HER2-low (immunohistochemistry (IHC) 1+ or IHC
2+/ in-situ hybridisation (ISH)-negative) breast cancer
who have received a prior systemic therapy 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. Patients with hormone receptor (HR)
positive breast cancer must additionally have received or be
ineligible for endocrine therapy.
Enhertu is also currently
under review in the US for the treatment of adult patients with
unresectable or metastatic non-small cell lung cancer (NSCLC) whose
tumours have a HER2 (ERBB2) mutation and who have received a prior
systemic therapy based on the results of the DESTINY-Lung01 trial,
and in Europe for the treatment of adult patients with locally
advanced or metastatic HER2-positive gastric or GEJ adenocarcinoma
who have received a prior anti-HER2 based regimen based on the
DESTINY-Gastric01 and DESTINY-Gastric02 trials.
Enhertu was granted
Breakthrough Therapy Designation in the US for the treatment of
adult patients with unresectable or metastatic HER2-low (IHC 1+ or
IHC 2+/ISH-negative) breast cancer who have received a prior
systemic therapy in the metastatic setting or developed disease
recurrence during or within six months of completing adjuvant
chemotherapy, based on the results of the DESTINY-Breast04 trial.
Patients with HR-positive breast cancer should additionally have
received or be ineligible for endocrine
therapy.
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 manufacturing and supply
of Enhertu 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 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, a HER2-directed ADC, 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 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. Cortes J, et al. Trastuzumab Deruxtecan versus
Trastuzumab Emtansine for Breast Cancer. N Engl J
Med 2022;
386:1143-1154.
2. Globocan 2020. Europe Fact Sheets. Available
at: https://gco.iarc.fr/today/data/factsheets/populations/908-europe-fact-sheets.pdf.
Last accessed: June 2022.
3. 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.
4. Barok M, et al. Trastuzumab emtansine:
mechanism of action and drug resistance. Breast Cancer
Res. 2014;
16(2):209.
5. Nader-Marta G, et al. How we treat patients
with metastatic HER2-positive breast
cancer. ESMO Open. 2022; 7:1.
6. Mounsey L, et al. Changing Natural History of
HER2-Positive Breast Cancer Metastatic to the Brain in the Era of
New Targeted Therapies. Clin Breast
Cancer. 2018;
18(1):29-37.
7. Martinez-S Sáez O, et al. Current and
Future Management of HER2-Positive Metastatic Breast
Cancer. JCO Oncol
Pract. 2021.
10.1200/OP.21.00172.
8. 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.
9. Iqbal N, et al. Human Epidermal Growth Factor
Receptor 2 (HER2) in Cancers: Overexpression and Therapeutic
Implications. Mol Biol
Int. 2014;852748.
10. 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.
|
AstraZeneca
PLC
|
Date:
27 June 2022
|
By: /s/
Adrian Kemp
|
|
Name:
Adrian Kemp
|
|
Title:
Company Secretary
|
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