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 October 2022
Commission File
Number: 001-11960
AstraZeneca
PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge CB2
0AA
United
Kingdom
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mark whether the registrant files or will file annual reports under
cover of Form 20-F or Form 40-F.
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permitted by Regulation S-T Rule 101(b)(7): ______
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mark whether the registrant by furnishing the information contained
in this Form is also thereby furnishing the information to the
Commission pursuant to Rule 12g3-2(b) under the Securities Exchange
Act of 1934.
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Registrant in connection with Rule 12g3-2(b):
82-_____________
AstraZeneca
PLC
INDEX
TO EXHIBITS
1.
Capivasertib Phase III trial met primary endpoints
26
October 2022 07:00 BST
Capivasertib
plus Faslodex significantly
improved progression-free survival vs. Faslodex in
CAPItello-291 Phase III trial in advanced HR-positive
breast cancer
Capivasertib, a potential first-in-class AKT inhibitor, combined
with Faslodex
could become a new option for patients in this setting regardless
of biomarker status
Positive high-level
results from the CAPItello-291 Phase III trial showed that
AstraZeneca's capivasertib in combination with Faslodex (fulvestrant)
demonstrated a statistically significant and clinically meaningful
improvement in progression-free survival (PFS) versus placebo
plus Faslodex in patients with
hormone receptor (HR)-positive, human epidermal growth factor receptor 2
(HER2)-low or negative locally advanced or metastatic breast
cancer, following recurrence or
progression on or after endocrine therapy (with or without a CDK4/6
inhibitor).
The trial met both
primary endpoints,
improving PFS in the overall
patient population and in a prespecified biomarker subgroup of
patients whose
tumours had qualifying alterations in the PIK3CA, AKT1 or PTEN
genes. Although the overall survival (OS) data were immature at the
time of the analysis, early data are encouraging. The trial will
continue to assess OS as a key
secondary endpoint.
The safety profile of
capivasertib plus Faslodex was similar to that
observed in previous trials evaluating this combination.
Breast cancer is the most common cancer worldwide,
with an estimated 2.3 million patients diagnosed in
2020.1 Approximately
70% of breast cancer tumours are considered HR-positive
and HER2-low or negative.2 Endocrine
therapies are widely used for the treatment of HR-positive breast
cancer, but many patients with advanced disease develop resistance
to 1st-line CDK4/6 inhibitors and estrogen receptor-targeting
therapies, underscoring the need for additional
options.3
Nicholas Turner, MD,
PhD, Professor of Molecular Oncology at The Institute of Cancer
Research, London, and The Royal Marsden NHS Foundation Trust,
London, UK, and principal investigator in the CAPItello-291 Phase
III trial, said: "The CAPItello-291 Phase III trial results show
capivasertib offers a clinically meaningful improvement
in progression free survival for patients with HR-positive breast cancer.
This potential new medicine could give people more time with their
cancer under control, which is a priority for patients and their
families."
Susan
Galbraith, Executive Vice President, Oncology R&D, AstraZeneca,
said: "These exciting data in an all-comers population indicate
that capivasertib could become a new first-in-class treatment
option for patients with HR-positive breast cancer. These patients
often experience tumour progression on, or resistance to, available
endocrine therapies for advanced disease and urgently need new
therapies that extend the effectiveness of endocrine-based
treatment approaches."
The data will be presented at a forthcoming
medical meeting and shared
with global health authorities.
AstraZeneca has a comprehensive
portfolio of approved and potential new medicines in development
for patients with breast cancer. In addition to these results, the
Company is also announcing today results from
the SERENA-2
Phase II trial of
camizestrant, the next-generation oral selective estrogen receptor
degrader (ngSERD) in
advanced estrogen receptor (ER)-positive breast
cancer.
Notes
HR-positive breast cancer
HR-positive breast cancer (expressing
estrogen or progesterone receptors, or both), is the most
common subtype of breast cancer, and the growth of HR-positive
breast cancer cells is often driven by ER.2,4,5 Endocrine
therapies that target ER-driven disease are widely used as 1st-line
treatment for this form of breast cancer in the advanced setting,
and often paired with cyclin-dependent kinase (CDK) 4/6 inhibitors.
However, resistance to CDK4/6 inhibitors and current endocrine
therapies develops in many patients with advanced disease and
treatment options are limited.3 Optimising
endocrine therapy and overcoming resistance for patients with
ER-driven disease at all stages of treatment are active areas of
focus for breast cancer research.
CAPItello-291
CAPItello-291 is a Phase III, double-blind,
randomised trial that is part of a larger clinical programme
focused on capivasertib, an investigational AKT (serine/threonine
kinase) inhibitor. CAPItello-291 is evaluating the efficacy of
capivasertib in combination with Faslodex versus placebo plus Faslodex for the treatment of locally advanced
(inoperable) or metastatic HR-positive, HER2-low or negative breast
cancer.
The global trial
enrolled 708 adult patients with histologically confirmed
HR-positive, HER2-low or negative breast cancer whose disease has
recurred or progressed during or after aromatase inhibitor therapy,
with or without a CDK4/6 inhibitor, and
up to one line of chemotherapy for advanced disease. The trial has
dual primary endpoints of PFS in the overall patient
population and in a subgroup of
patients whose tumours have qualifying alterations in the PIK3CA,
AKT1 or PTEN genes. In the trial, approximately 40% of tumours had
PI3K/AKT/PTEN alterations.
Capivasertib
Capivasertib
is an investigational oral treatment currently in Phase III trials
for the treatment of multiple subtypes of breast cancer, prostate
cancer and a Phase II trial for haematologic malignancies. A
potent, selective adenosine triphosphate (ATP)-competitive
inhibitor of all three AKT isoforms (AKT1/2/3), capivasertib
is being evaluated in combination with existing therapies in
tumours harbouring alterations in the PI3K/AKT/PTEN pathway, and in
tumours reliant on signalling via this pathway for
survival. Capivasertib is dosed according to an intermittent
schedule, which consists of four days on and three days off. This
was chosen in early phase trials based on tolerability and the
degree of target inhibition.
The
capivasertib clinical research programme is investigating the
safety and efficacy of capivasertib when used in combination with
established treatment regimens.
Capivasertib was discovered by AstraZeneca subsequent to a
collaboration with Astex Therapeutics (and its collaboration with
the Institute of Cancer Research and Cancer Research Technology
Limited).
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.
With Enhertu (trastuzumab deruxtecan), a HER2-directed
ADC, AstraZeneca and Daiichi Sankyo are aiming to improve outcomes
in previously treated HER2-positive and HER2-low metastatic breast
cancer and are exploring its potential in earlier lines of
treatment and in new breast cancer settings.
In HR-positive breast cancer, AstraZeneca
continues to improve outcomes with foundational
medicines Faslodex (fulvestrant) and Zoladex (goserelin) and aims to reshape the
HR-positive space with ngSERD and potential new medicine
camizestrant as well as a potential first-in-class AKT kinase
inhibitor, capivasertib. AstraZeneca is also collaborating with
Daiichi Sankyo to explore the potential of TROP2-directed ADC,
datopotamab deruxtecan, in this setting.
PARP inhibitor Lynparza (olaparib) is a targeted treatment option
that has been studied in 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.
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 capivasertib in
combination with chemotherapy, 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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Relations Team, 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. National Cancer
Institute. Surveillance, Epidemiology and End Results Program.
Available at https://seer.cancer.gov/statfacts/html/breast-subtypes.html Accessed
October 2022.
3. Lin M, et al. Comparative Overall Survival of
CDK4/6 Inhibitors Plus Endocrine Therapy vs. Endocrine Therapy
Alone for Hormone receptor-positive, HER2-negative metastatic
breast cancer. J
Cancer.
2020; 10.7150/jca.48944.
4. Bae
SY, et al. Poor prognosis of single hormone receptor- positive
breast cancer: similar outcome as triple-negative breast
cancer. BMC Cancer. 2015;
10.1186/s12885-015-1121-4.
5. Lumachi F, et al. Current medical
treatment of estrogen receptor-positive breast
cancer. World J Biol
Chem. 2015;
10.4331/wjbc.v6.i3.231.
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:
26 October 2022
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By: /s/
Adrian Kemp
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Name:
Adrian Kemp
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Title:
Company Secretary
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