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 June 2024
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
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by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F.
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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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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
Update on CAPItello-290 Phase III trial
18 June 2024
Update on
the CAPItello-290 Phase III trial for Truqap plus
chemotherapy
in advanced or metastatic triple-negative breast
cancer
The CAPItello-290 Phase III trial for Truqap (capivasertib)
in combination with paclitaxel in patients with locally advanced
(inoperable) or metastatic triple-negative breast cancer (TNBC) did
not meet the dual primary endpoints of improvement in overall
survival (OS) versus paclitaxel in combination with placebo in
either the overall trial population or in a subgroup of patients
with tumours harbouring specific biomarker alterations (PIK3CA,
AKT1 or PTEN).
Breast cancer is the second most common cancer and one of the
leading causes of cancer-related deaths
worldwide.1 While
some breast cancers may test positive for estrogen receptors,
progesterone receptors or overexpression of human epidermal growth
factor receptor 2 (HER2), TNBC is defined as negative for all
three.2 In
the 1st-line setting, approximately 59,000 patients with TNBC are
treated with a medicine.3 Collectively,
mutations in PIK3CA, AKT1 and alterations in PTEN affect
approximately 35% of patients with TNBC.4
Peter Schmid, MD, Barts Cancer Institute, London, UK, and principal
investigator for the trial said: "Despite modest
advances, triple-negative
breast cancer remains one of the most challenging forms of disease
to treat due to the lack of known actionable biomarker targets, and
chemotherapy-based regimens continue to be the mainstay of
treatment. While the CAPItello-290 trial results have not shown
what we hoped, they provide important information to further
understand this aggressive form of breast cancer where patients are
in urgent need of new treatments."
Susan Galbraith, Executive Vice President, Oncology R&D,
AstraZeneca, said: "We are committed to advancing science for
patients in some of the most challenging cancers, including this
heterogeneous subtype of breast cancer. While we are disappointed
in the CAPItello-290 outcome, these results will further our
understanding of the role of the PI3K/AKT pathway in breast cancer
as we continue our clinical research across
the Truqap clinical
development programme and across our pipeline."
The safety profile of Truqap in combination with paclitaxel in
CAPItello-290 was broadly consistent with the known safety profile
of each medicine with no new safety concerns identified. Data
will be shared in due course.
Truqap is currently being
evaluated in Phase III trials for the treatment of breast cancer
(CAPItello-292) and prostate cancer (CAPItello-280 and
CAPItello-281) in combination with established
treatments.
Notes
Triple-negative breast cancer
1st-line treatment for advanced or metastatic TNBC usually consists
of chemotherapy alone or in combination with an immunotherapy -
options generally associated with response rates between 30 to
50%.2,5,6 Among
patients with tumours that do respond to initial treatment, disease
progression is common and rapid, often occurring within two
years.2,6-8 The
average overall survival of patients living with advanced or
metastatic TNBC is 12 to 18 months, with only about 14% of patients
living five years following diagnosis.9,10
CAPItello-290
CAPItello-290 is a Phase III, double-blind, randomised trial
evaluating the efficacy and safety of Truqap in
combination with paclitaxel versus placebo in combination with
paclitaxel in the 1st-line treatment of patients with locally
advanced (inoperable) or metastatic TNBC.
The global trial enrolled 923 adult patients
with histologically
confirmed locally advanced or metastatic TNBC. The trial has
dual primary endpoints of OS in the overall patient population and
in a population of patients whose tumours have qualifying
alterations in the PI3K/AKT pathway (PIK3CA, AKT1 or PTEN
genes).
Truqap
Truqap is a
first-in-class, potent, adenosine triphosphate (ATP)-competitive
inhibitor of all three AKT isoforms
(AKT1/2/3). Truqap 400mg is administered twice daily according
to an intermittent dosing schedule of four days on and three days
off. This was chosen in early phase trials based on tolerability
and the degree of target inhibition.
Truqap is approved in the
US, Japan and several other countries for the treatment of adult
patients with HR-positive, HER2-negative locally advanced or
metastatic breast cancer with one or more biomarker alterations
(PIK3CA, AKT1 or PTEN) following recurrence or progression on or
after an endocrine-based regimen based on the results from the
CAPItello-291 trial. Truqap is also approved in Australia for the
treatment of adult patients with HR-positive, HER2-negative locally
advanced or metastatic breast cancer following recurrence or
progression on or after an endocrine based regimen based on these
trial results.
Truqap is currently being
evaluated in Phase III trials for the treatment of breast cancer
(CAPItello-292) and prostate cancer (CAPItello-280 and
CAPItello-281) in combination with established
treatments.
Truqap 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
antibody drug conjugate (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 and Zoladex (goserelin) and aims to reshape the
HR-positive space with first-in-class AKT
inhibitor, Truqap, and next-generation SERD and potential new
medicine camizestrant. 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 these settings and to explore its
potential in earlier disease.
To bring much-needed treatment options to patients with
triple-negative breast cancer, an aggressive form of breast cancer,
AstraZeneca is evaluating the potential of datopotamab deruxtecan
alone and in combination with
immunotherapy Imfinzi (durvalumab),
and Imfinzi in combination with other oncology
medicines, including Lynparza and Enhertu.
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 social media @AstraZeneca.
Contacts
For details on how to contact the Investor Relations Team, please
click here.
For Media contacts, click here.
References
1. Bray F, et al. Global cancer
statistics 2022: GLOBOCAN estimates of incidence and mortality
worldwide for 36 cancers in 185 countries. CA Cancer J
Clin. 2024 Apr 4. doi:
10.3322/caac.21834.
2. O'Reilly
D, et al. Overview of recent advances in metastatic triple negative
breast cancer. World J Clin
Oncol. 2021;
12(3):164-182.
3. Cerner
CancerMPact database. Accessed May 2024.
4. Cocco
S, et al. Biomarkers in Triple-Negative Breast Cancer:
State-of-the-Art and Future Perspectives. Int J Mol
Sci. 2020;
21(13): 4579.
5. Bergin
A, et al. Triple-negative breast cancer: recent treatment
advances. F1000Res.
2019; 8:10.12688/f1000research.18888.1.
6. Zhang
Y, et al. Genomic features of rapid versus late relapse in triple
negative breast cancer. BMC
Cancer. 2021;
21(568).
7. Cortes
J, et al. Pembrolizumab plus Chemotherapy in Advanced Triple
-Negative Breast
Cancer. N Engl J
Med. 2022; 387:217-226.
10.1056/NEJMoa2202809.
8. Emans
L, et al. Atezolizumab and nab-Paclitaxel in Advanced
Triple-Negative Breast Cancer: Biomarker Evaluation of the
IMpassion130 Study. J Natl Cancer
Inst. 2021;
113(8): Djab004.
9. National
Cancer Institute. Surveillance, Epidemiology and End Results
Program. Available
at: https://seer.cancer.gov/statfacts/html/breast-subtypes.html.
Accessed June 2024.
10. Sharma
P, et al. Biology and Management of Patients with Triple-Negative
Breast Cancer. Oncologist.
2016; 21(9);1050-62.
10.1634/theoncologist.2016-0067.
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:
18 June 2024
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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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