TIDMAZN
RNS Number : 2102Q
AstraZeneca PLC
27 June 2022
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 . I f 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
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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
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