TIDMAZN
RNS Number : 9389V
AstraZeneca PLC
15 August 2022
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
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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
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