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 April 2025
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
Indicate
by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F.
Form
20-F X Form 40-F __
Indicate
by check mark if the registrant is submitting the Form 6-K in paper
as permitted by Regulation S-T Rule 101(b)(1):
Indicate
by check mark if the registrant is submitting the Form 6-K in paper
as permitted by Regulation S-T Rule 101(b)(7): ______
Indicate
by check 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.
Yes __
No X
If
“Yes” is marked, indicate below the file number
assigned to the Registrant in connection with Rule 12g3-2(b):
82-_____________
AstraZeneca PLC
INDEX
TO EXHIBITS
1.
Update on CAPItello-280 Phase III trial
29
April 2025
Update on CAPItello-280 Phase III trial of Truqap in metastatic
castration-resistant prostate cancer
AstraZeneca is discontinuing the CAPItello-280 Phase III trial
evaluating the efficacy and safety of Truqap (capivasertib)
in combination with docetaxel and androgen-deprivation therapy
(ADT) compared to docetaxel and ADT with placebo in patients with
metastatic castration-resistant prostate cancer
(mCRPC).
This decision is based on the recommendation of the Independent
Data Monitoring Committee (IDMC) following their review of data
from a pre-specified interim analysis, which concluded that
the Truqap combination
was unlikely to meet the dual primary endpoints
of radiographic progression-free survival (rPFS)
and overall survival
(OS) versus the comparator arm upon trial completion. The safety
profile for Truqap was
consistent with previous trials.
The Company will work with investigators to ensure the necessary
follow up with patients. Data from the trial will inform ongoing
research.
Notes
Prostate cancer
Prostate cancer is the second most prevalent cancer in men and the
fifth leading cause of male cancer death globally, with an
incidence of more than 1.4 million and over 397,000 deaths in
2022.1
Metastatic prostate cancer is associated with a significant
mortality rate, with only one third of patients surviving five
years after diagnosis.2 Development of
prostate cancer is often driven by male sex hormones called
androgens, including testosterone.3
Metastatic castration-resistant
prostate cancer
Approximately 10-20% of men with advanced prostate cancer will
develop castration-resistant prostate cancer within five
years.4 In
patients with mCRPC, their prostate cancer grows and spreads to
other parts of the body despite the use of androgen-deprivation
therapy to block the action of male sex
hormones.3 At
least 84% of these men will have metastases at the time of CRPC
diagnosis and, of those patients with no metastases at CRPC
diagnosis, 33% are likely to develop metastases within two
years.4 Approximately
half of patients with mCRPC may receive only one line of active
treatment, and those that go on to receive further treatment often
have diminishing benefit of subsequent
therapies.5-6
Despite the advances in mCRPC treatment with taxane and new
hormonal agent treatments, there is high unmet need in this
population.4,7,8
CAPItello-280
CAPItello-280 is a Phase III, double-blind, randomised trial
evaluating the efficacy and safety of Truqap in
combination with docetaxel and ADT compared to docetaxel and ADT in
combination with placebo in patients with
mCRPC.
The global trial enrolled 1,033 adult patients with histologically
confirmed prostate adenocarcinoma with evidence of mCRPC with
progression of disease despite ADT. The dual primary endpoints of
the CAPItello-280 trial are rPFS as assessed by investigator and OS
in the overall trial population. Key secondary endpoints include OS
and rPFS as assessed by investigator in patients with mCRPC and
PTEN-deficient tumours, OS and rPFS as assessed by investigator in
patients with mCRPC and PTEN-proficient tumours, time to pain
progression (TTPP) in the overall trial population
and time to
first symptomatic skeletal-related event (SSRE) in the overall
trial population.
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 in combination with Faslodex (fulvestrant) is
approved in the US, EU, Japan, China and several other countries
for the treatment of adult patients with HR-positive (or estrogen
receptor-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 being evaluated in ongoing Phase III trials
for the treatment of breast and prostate cancers.
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 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's innovative
medicines are sold in more than 125 countries and 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. Chowdhury
S, et al. Real-World Outcomes in First-Line Treatment of Metastatic
Castration-Resistant Prostate Cancer: The Prostate Cancer
Registry. Target
Oncol.
2020;15(3):301-315.
3. National Cancer
Institute. Hormone Therapy for Prostate Cancer Fact Sheet.
Available at: https://www.cancer.gov/types/prostate/prostate-hormone-therapy-fact-sheet.
Accessed April 2025.
4. Kirby
M, et al. Characterising the Castration-Resistant
Prostate Cancer Population: Systematic
Review. Int J of Clin
Pract.
2021;65(11):1180-1192.
5. George
DJ, et al. Treatment Patterns and Outcomes in Patients with
Metastatic Castration-Resistant Prostate Cancer in a Real-World
Clinical Practice Setting in the United
States. Clin Genitourin
Cancer.
2020;18:284-294.
6. de
Wit, R, et al. Real-World Evidence of Patients with Metastatic
Castration-Resistant Prostate Cancer Treated with Cabazitaxel:
Comparison with the Randomized Clinical Study
CARD. Prostate Cancer
Prostatic Dis. 2022;2660.
7. UroToday. What is
Changing in Advanced Prostate Cancer? Available
at: https://www.urotoday.com/journal/everyday-urology-oncology-insights/articles/122176-what-is-changing-in-advanced-prostate-cancer.html.
Accessed April 2025.
8. Liu
J, et al. Second-Line
Hormonal Therapy for the Management of Metastatic
Castration-Resistant Prostate Cancer: A Real-World Data Study Using
a Claims Database. Sci
Rep. 2020;10(1):4240.
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.
|
|
AstraZeneca
PLC
|
Date:
29 April 2025
|
|
By: /s/
Adrian Kemp
|
|
|
Name:
Adrian Kemp
|
|
|
Title:
Company Secretary
|