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 May 2026
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.
FDA ODAC recommends Truqap in prostate cancer
01 May 2026
Truqap recommended by FDA Advisory Committee for
PTEN-deficient metastatic hormone-sensitive prostate
cancer
ODAC
overwhelming majority voted that Truqap plus abiraterone and ADT
demonstrated a favourable benefit risk profile for patients based
on the CAPItello-281 Phase III trial results
First and only targeted treatment combination to demonstrate
benefit in this subtype of prostate cancer addresses significant
unmet patient need
The US Food and Drug Administration's (FDA) Oncologic Drugs
Advisory Committee (ODAC) has recognised a favourable benefit risk
profile for AstraZeneca's Truqap (capivasertib) in
combination with abiraterone and androgen deprivation therapy (ADT)
for the treatment of patients with PTEN-deficient metastatic
hormone-sensitive prostate cancer (mHSPC), based on the
CAPItello-281 Phase III trial. The Committee voted 7 to 1, with 1
abstaining.
In August 2025, the FDA accepted the supplemental New Drug
Application (sNDA) for Truqap in combination with abiraterone and ADT
based on positive results from the CAPItello-281 Phase III trial,
presented at the 2025 European Society for Medical Oncology (ESMO)
Congress and simultaneously published in Annals
of Oncology.1
Daniel George, MD, Director of Genitourinary Oncology at Duke
Cancer Institute and investigator for the trial, said: "Patients
identified to have PTEN-deficient metastatic hormone-sensitive
prostate cancer have an aggressive form of the disease and
currently experience poor outcomes. Their
disease significantly impacts their quality of life and
inevitably progresses to more advanced stages that are
associated with high mortality rates. In addition to this poor
prognosis, patients currently have limited treatment
options, which is why today's recommendation of the
capivasertib combination is welcome news for both patients and
clinicians to address an urgent need for new treatments that delay
progression."
Susan Galbraith, Executive Vice President, Oncology Haematology
R&D, AstraZeneca, said: "CAPItello-281 is the first pivotal
trial to prospectively define PTEN-deficient metastatic
hormone-sensitive prostate cancer and its severe course of disease.
The Committee's recognition of the unmet need in patients with
PTEN-deficiency and of the benefit seen with
the Truqap combination verifies its potential to
address this significant need and optimise outcomes for
patients. We are committed to working closely with the FDA to
bring the first and only targeted treatment option to the one in
four patients with this form of metastatic hormone-sensitive
prostate cancer."
Results from the primary analysis of the CAPItello-281 Phase III
trial showed a statistically significant 19% reduction in the risk
of radiographic disease progression or death and a clinically
meaningful improvement in median radiographic
progression-free survival (rPFS) of 7.5 months with
the Truqap combination versus treatment with
abiraterone and ADT with placebo (based on a hazard ratio [HR] of
0.81; 95% confidence interval [CI] 0.66-0.98; p=0.034). Median rPFS
was 33.2 months for the Truqap combination versus 25.7 months for the
comparator arm.1
A consistent benefit was observed with the Truqap combination versus treatment with
abiraterone and ADT with placebo in key secondary endpoints of the
trial, including prolonged
time to castration resistance (29.5 vs. 22.0 months [HR 0.77; 95%
CI: 0.63-0.94]) and prostate-specific antigen (PSA) progression
(HR 0.73; 95% CI:
0.52-1.01), and fewer and delayed events in terms of symptomatic
skeletal event-free survival (SSE-FS) (42.5 vs. 37.3 months [HR
0.82, 95% CI: 0.66-1.02]).1
Overall survival (OS) data were immature at the time of primary
analysis; however, subsequent interim results for OS numerically
favoured the Truqap combination
versus the comparator arm. The trial will continue as planned to
further assess OS as a key secondary endpoint.
The safety profile of Truqap in
combination with abiraterone and ADT in CAPItello-281 was broadly
consistent with the known profile of each
medicine. Consistent
with the addition of a targeted treatment to background therapy,
Grade 3 or higher adverse events occurred in 67% of patients
treated with the Truqap combination
versus 40.4% of patients treated with abiraterone and ADT with
placebo. The most common Grade 3 or higher adverse events in
the Truqap arm
were rash (12.3%), hyperglycaemia (10.3%), hypokalaemia (8.7%),
diarrhoea (6.2%), hypertension (5.8%) and anaemia
(5.2%).1
The ODAC provides the FDA with independent, expert advice and
recommendations on marketed and investigational medicines for use
in the treatment of cancer. The FDA will consider the feedback as
it reviews the submission and is not bound by the Committee's
recommendation.
A regulatory application for Truqap in combination with abiraterone and ADT for
the treatment of PTEN-deficient mHSPC is under review in the EU
based on the CAPItello-281 Phase III trial.
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 approximately 397,000 deaths
in 2022.2 In
the US, prostate cancer is the most common cancer in men, with more
than 300,000 new cases of the disease diagnosed annually, and more
than 36,000 deaths.3
Metastatic prostate cancer is associated with a significant
mortality rate, with only one third of patients surviving five
years after diagnosis.4 Development
of prostate cancer is often driven by male sex hormones called
androgens, including testosterone.5
Metastatic hormone-sensitive prostate cancer
In patients with mHSPC, also known as metastatic
castration-sensitive prostate cancer (mCSPC), prostate cancer cells
need high levels of androgens to drive cancer
growth.5,6 Hormone
therapies, such as ADT, are widely used to block the action of male
sex hormones and lower the levels of androgens in the
body.6,7 However,
resistance to these therapies is common and there is a need to
extend their use to delay disease progression and castration
resistance, where the prostate cancer grows and spreads to other
parts of the body despite the use of these
therapies.6-8
Newly diagnosed mHSPC is an aggressive form of the disease
associated with poor outcomes and survival.6,8 Globally,
approximately 200,000 patients are diagnosed with mHSPC each year,
with 35,000 patients diagnosed with the disease in the
US.9 One
in four of these patients have PTEN-deficient
tumours.9
PTEN-loss or deficiency fuels the growth of cancer cells, leading
to dysregulation of the PI3K/AKT pathway, and is associated with
poor outcomes in patients with prostate cancer.10,11
CAPItello-281
CAPItello-281 is a Phase III, double-blind, randomised trial
evaluating the efficacy and safety of Truqap in
combination with abiraterone and ADT versus abiraterone and ADT in
combination with placebo in the treatment of patients with
PTEN-deficient de
novo mHSPC.
The global trial enrolled 1,012 adult patients with histologically
confirmed de
novo hormone-sensitive
prostate adenocarcinoma and PTEN deficiency as confirmed by central
testing. The primary endpoint of the CAPItello-281 trial is rPFS as
assessed by investigator, with OS as a secondary
endpoint.
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 a number of 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 currently being
evaluated in Phase III trials for the treatment of breast cancer
(CAPItello-292) and prostate cancer (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 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/NYSE: 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
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References
1. Fizazi K, et al. Capivasertib plus
abiraterone in PTEN-deficient metastatic hormone sensitive prostate
cancer: CAPItello-281 phase III study. Ann Oncol 2026; 37(1):53-68.
2. 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.
3. American Cancer Society. Key
Statistics for Prostate cancer. Available
at: https://www.cancer.org/cancer/types/prostate-cancer/about/key-statistics.html.
Accessed April 2026.
4.
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.
5. 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 2026.
6. American Society of Clinical
Oncology Educational Book. Metastatic Hormone-Sensitive Prostate
Cancer: Toward an Era of Adaptive and Personalized Treatment.
Available at: https://ascopubs.org/doi/pdf/10.1200/EDBK_390166.
Accessed April 2026.
7. Cancer Research UK. Hormone therapy
for metastatic prostate cancer. Available
at: https://www.cancerresearchuk.org/about-cancer/prostate-cancer/metastatic-cancer/treatment/hormone-therapy-for-metastatic-prostate-cancer.
Accessed April 2026.
8.
Hussain M, et al. Metastatic Hormone-Sensitive Prostate Cancer and
Combination Treatment Outcomes A Review. JAMA Oncol.
2024;10(6):807-820.
9.
Cerner CancerMPact database. Accessed April 2026.
10.
Cuzick J, et al. Prognostic value of PTEN loss in men with
conservatively managed localised prostate cancer. Br J Cancer.
2013;108(12):2582-2589.
11.
Gasmi A, et al. Overview of the Development and Use of Akt
Inhibitors in Prostate Cancer. J Clin Med.
2021;11(1):160.
Matthew Bowden
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: 01 May 2026
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By: /s/
Matthew Bowden
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Name:
Matthew Bowden
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Title:
Company Secretary
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