TIDMAZN
RNS Number : 9262R
AstraZeneca PLC
06 March 2023
06 March 2023 07:00 GMT
Enhertu showed clinically meaningful and durable responses
across multiple HER2-expressing tumour types in DESTINY-PanTumor02
Phase II trial
AstraZeneca and Daiichi Sankyo's Enhertu met prespecified
criteria for objective response rate and duration of response
Positive high-level results from an analysis of the ongoing
DESTINY-PanTumor02 Phase II trial showed AstraZeneca and Daiichi
Sankyo's Enhertu (trastuzumab deruxtecan) met the prespecified
target for objective response rate (ORR) and demonstrated durable
response across multiple HER2-expressing advanced solid tumours in
heavily pretreated patients.
Enhertu is a specifically engineered HER2-directed antibody drug
conjugate (ADC) being jointly developed and commercialised by
AstraZeneca and Daiichi Sankyo.
The DESTINY-PanTumor02 Phase II trial is evaluating the efficacy
and safety of Enhertu in patients with locally advanced,
unresectable, or metastatic previously treated , HER2-expressing
solid tumours not eligible for curative therapy, including biliary
tract, bladder, cervical, endometrial, ovarian, pancreatic, and
rare cancers. The primary endpoint of the trial is
investigator-assessed confirmed ORR and investigator-assessed
duration of response (DoR) is a key secondary endpoint.
The data will be presented at an upcoming medical meeting and
shared with global regulatory authorities.
HER2 is a tyrosine kinase receptor protein expressed on the
surface of various tissue cells throughout the body and is involved
in normal cell growth.(1,2) In some cancer cells, HER2 expression
is amplified or the cells have activating mutations.(1,3) While
HER2-directed therapies have been used to treat breast, gastric and
lung cancers, more research is needed evaluating their potential
role in treating other HER2-expressing tumour types.(2,4-6)
Cristian Massacesi, Chief Medical Officer and Oncology Chief
Development Officer, AstraZeneca, said, "Enhertu has already
demonstrated its potential to improve outcomes for patients with
HER2-targetable breast, gastric and lung cancers, and these
positive initial results in other tumour settings with significant
unmet need are very encouraging. The DESTINY-PanTumor02 results
mark an important step forward in our understanding of the
potential role of Enhertu across multiple HER2-expressing tumour
types."
Ken Takeshita, Global Head, R&D, Daiichi Sankyo, said, "The
clinically meaningful responses seen in the DESTINY-PanTumor02
trial reaffirm our belief in the potential of Enhertu across
multiple HER2-expressing cancers. The results seen so far across
multiple cohorts of the trial will inform next steps of our broad
development programme as we look to bring this important medicine
to as many patients as quickly as possible."
The safety profile observed in patients treated with Enhertu in
the DESTINY-PanTumor02 trial was consistent with that seen in other
trials of Enhertu with no new safety signals identified.
Notes
DESTINY-PanTumor02
DESTINY-PanTumor02 is a global, multicentre, multi-cohort,
open-label Phase II trial evaluating the efficacy and safety of
Enhertu (5.4mg/kg) for the treatment of HER2-expressing tumours,
including biliary tract cancer, bladder cancer, cervical cancer,
endometrial cancer, ovarian cancer, pancreatic cancer and rare
tumours.
The primary efficacy endpoint of DESTINY-PanTumor02 is confirmed
ORR as assessed by investigator. Secondary endpoints include DoR,
disease control rate, progression-free survival, overall survival,
safety, tolerability and pharmacokinetics.
DESTINY-PanTumor02 has enrolled 268 patients at multiple sites
in Asia, Europe and North 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 40 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 more than 30 countries for the
treatment of adult patients with unresectable or metastatic
HER2-low (immunohistochemistry [IHC] 1+ or IHC 2+/in-situ
hybridisation [ISH]-) 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.
Enhertu (5.4mg/kg) is approved under accelerated approval in the
US for the treatment of adult patients with unresectable or
metastatic non-small cell lung cancer whose tumours have activating
HER2 (ERBB2) mutations, as detected by an FDA-approved test, and
who have received a prior systemic therapy based on the results
from the DESTINY-Lung02 trial. Continued approval for this
indication may be contingent upon verification and description of
clinical benefit in a confirmatory trial.
Enhertu (6.4mg/kg) is approved in more than 30 countries for the
treatment of adult patients with locally advanced or metastatic
HER2-positive gastric or gastroesophageal junction adenocarcinoma
who have received a prior trastuzumab-based regimen based on the
results from the DESTINY-Gastric01 trial and/or DESTINY-Gastric02
trial.
Enhertu development programme
A comprehensive global development programme is underway
evaluating the efficacy and safety of Enhertu monotherapy across
multiple HER2-targetable cancers. Trials in combination with other
anticancer treatments, such as immunotherapy, are also
underway.
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 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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References
1. ASCO. Breast Cancer. Available at: https://www.cancer.net/sites/cancer.net/files/asco_answers_guide_breast.pdf . Accessed March 2023.
2. Iqbal N, et al. Human Epidermal Growth Factor Receptor 2
(HER2) in Cancers: Overexpression and Therapeutic Implications Mol
Biol Int. 2014;852748.
3. Omar N, et al. HER2-an emerging biomarker in non-breast and non-gastric cancers. Pathogenesis. 2015;2(3):1-9.
4. Wu VS, et al. From bench to bedside: What do we know about
hormone receptor-positive and human epidermal growth factor
receptor 2-positive breast cancer? J Steroid Biochem Mol Biol.
2015;153;45-53.
5. American Cancer Society. Targeted Drug Therapy for Stomach Cancer. Available at: https://www.cancer.org/cancer/stomach-cancer/treating/targeted-therapies.html . Accessed March 2023.
6. National Cancer Institute. Enhertu Marks First Targeted
Therapy for HER2-Mutant Lung Cancer. Available at:
https://www.cancer.gov/news-events/cancer-currents-blog/2022/fda-lung-cancer-enhertu-her2
. Accessed March 2023.
Adrian Kemp
Company Secretary
AstraZeneca PLC
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