TIDMAZN
RNS Number : 1531E
AstraZeneca PLC
26 October 2022
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 loca lly 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
For details on how to contact the Investor 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
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