a9303r
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 March 2023
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
Enhertu DESTINY-PanTumor02 shows positive results
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
For details on how to contact the Investor Relations Team, please
click here.
For Media contacts, click here.
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
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:
06 March 2023
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By: /s/
Adrian Kemp
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|
Name:
Adrian Kemp
|
|
Title:
Company Secretary
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