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 December 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 LATIFY Phase III trial of ceralasertib
22 Dec 2025
Update on LATIFY Phase III trial of
ceralasertib plus Imfinzi in
previously treated advanced non-small cell lung cancer
The LATIFY Phase III trial of ceralasertib in combination
with Imfinzi (durvalumab) did not meet the primary
endpoint of overall survival (OS) versus standard-of-care docetaxel
in patients with locally advanced or metastatic non-small cell lung
cancer (NSCLC). The trial evaluated patients without actionable
genomic alterations (AGAs) whose disease progressed on or after
prior immunotherapy and platinum-based
chemotherapy.
Susan Galbraith, Executive Vice President, Oncology Haematology
R&D, AstraZeneca, said: "Our goal in the LATIFY trial was to
reinvigorate the immune response of patients with lung cancer whose
tumours stopped responding to available therapies by combining ATR
inhibition with immunotherapy. While we are disappointed by this
result, we remain committed to pioneering new medicines to address
the urgent need to improve outcomes for patients with lung cancer
through our industry-leading portfolio."
The combination of ceralasertib and Imfinzi was generally well tolerated, and the safety
profile was consistent with the known profiles of each individual
medicine, with no new safety concerns identified. These data will
be presented at a forthcoming medical meeting.
Notes
NSCLC
Lung cancer is the leading cause of cancer death among both men and
women, accounting for about one-fifth of all cancer
deaths.1 Lung
cancer is broadly split into small cell lung cancer (SCLC) or
NSCLC, the latter accounting for about 80-85% of
cases.2-3 Patients
are most commonly diagnosed with metastatic disease, when the
tumour has spread outside the lung.4 Approximately
12% of people with metastatic NSCLC will still be alive five years
after diagnosis.5
LATIFY
LATIFY is a randomised, open-label, multi-centre, global Phase III
trial of ceralasertib plus Imfinzi in patients with locally advanced or
metastatic NSCLC without AGAs, and whose disease has progressed on
or after prior anti-PD-(L)1 therapy and platinum-based
chemotherapy. Patients were randomised 1:1 to receive ceralasertib
240mg twice daily oral tablets for seven days in combination with a
1,500mg fixed dose of Imfinzi on day eight every four weeks or docetaxel
every three weeks until disease progression, unacceptable toxicity,
withdrawal of consent or a discontinuation criterion was
met.
The trial enrolled 594 patients across more than 20 countries. The
primary endpoint is OS and secondary endpoints include
progression-free survival, objective response rate, duration of
response, time to response, disease control rate and patient
reported outcomes.
Ceralasertib
Ceralasertib is an oral, potent and selective inhibitor of the ATR
kinase, which is crucial for DNA damage responses and cell
survival. Ceralasertib acts on the tumour microenvironment, moving
it from a suppressed immune state into an activated state when
combined with immunotherapy.
Imfinzi
Imfinzi (durvalumab) is a
human monoclonal antibody that binds to the PD-L1 protein and
blocks the interaction of PD-L1 with the PD-1 and CD80 proteins,
countering the tumour's immune-evading tactics and releasing the
inhibition of immune responses.
In lung cancer, Imfinzi is the global standard of care based on OS
in the curative-intent setting of unresectable, Stage III NSCLC in
patients whose disease has not progressed after chemoradiotherapy
(CRT). Additionally, Imfinzi is approved as a perioperative treatment in
combination with neoadjuvant chemotherapy in resectable NSCLC, and
in combination with a short course of Imjudo (tremelimumab) and chemotherapy for the
treatment of metastatic NSCLC. Imfinzi is also approved for limited-stage SCLC in
patients whose disease has not progressed following concurrent
platinum-based CRT; and in combination with chemotherapy for the
treatment of extensive-stage SCLC.
In addition to its indications in lung
cancers, Imfinzi is also approved in combination with
chemotherapy in locally advanced or metastatic biliary tract cancer
and in combination with Imjudo in unresectable hepatocellular carcinoma
(HCC). Imfinzi is also approved as a monotherapy in
unresectable HCC in Japan and the European Union (EU), and in
resectable, early-stage and locally advanced gastric and
gastroesophageal junction cancers in the US.
Perioperative Imfinzi in combination with neoadjuvant chemotherapy
is approved for muscle-invasive bladder cancer. In May
2025, Imfinzi added to Bacillus Calmette-Guerin induction
and maintenance therapy met the primary endpoint of disease-free
survival for patients with high-risk non-muscle-invasive bladder
cancer in the POTOMAC Phase III trial.
Imfinzi in combination
with chemotherapy followed by Imfinzi monotherapy is approved as a 1st-line
treatment for primary advanced or recurrent endometrial cancer
(mismatch repair deficient disease only in the US and
EU). Imfinzi in combination with chemotherapy followed
by Lynparza (olaparib) and Imfinzi is approved for patients with mismatch
repair proficient advanced or recurrent endometrial cancer in the
EU and Japan.
Since the first approval in May 2017, more than 414,000 patients
have been treated with Imfinzi. As part of a broad development
programme, Imfinzi is being tested as a single treatment and in
combinations with other anti-cancer treatments for patients with
NSCLC, bladder cancer, breast cancer, ovarian cancer and several
gastrointestinal cancers.
AstraZeneca in immuno-oncology (IO)
AstraZeneca is a pioneer in introducing the concept of
immunotherapy into dedicated clinical areas of high unmet medical
need. The Company has a comprehensive and diverse IO portfolio and
pipeline anchored in immunotherapies designed to overcome evasion
of the anti-tumour immune response and stimulate the body's immune
system to attack tumours.
AstraZeneca strives to redefine cancer care and help transform
outcomes for patients with Imfinzi as a monotherapy and in combination
with Imjudo as well as other novel immunotherapies and
modalities. The Company is also investigating next-generation
immunotherapies like bispecific antibodies and therapeutics that
harness different aspects of immunity to target cancer, including
cell therapy and T-cell engagers.
AstraZeneca is pursuing an innovative clinical strategy to bring
IO-based therapies that deliver long-term survival to new settings
across a wide range of cancer types. The Company is focused on
exploring novel combination approaches to help prevent treatment
resistance and drive longer immune responses. With an extensive
clinical programme, the Company also champions the use of IO
treatment in earlier disease stages, where there is the greatest
potential for cure.
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. World Health
Organization. International Agency for Research on Cancer. Lung
Cancer Fact Sheet. Available at: https://gco.iarc.who.int/media/globocan/factsheets/cancers/15-trachea-bronchus-and-lung-fact-sheet.pdf.
Accessed November 2025.
2. American Cancer
Society. What Is Lung Cancer? Available
at: https://www.cancer.org/cancer/types/lung-cancer/about/what-is.html. Accessed November 2025.
3. Cagle
PT, et
al. Lung
Cancer Biomarkers: Present Status and Future
Developments. Arch Pathol Lab
Med. 2013;137(9):1191-1198.
4. Chen Y, Deng J, Liu Y, Wang H, Zhao
S, He Y, Zhou C. Analysis of metastases in non-small cell lung
cancer patients with epidermal growth factor receptor
mutation. Ann Transl
Med. 2021
Feb;9(3):206.
5. American Cancer
Society. Lung Cancer Survival Rates. Available
at: https://www.cancer.org/cancer/types/lung-cancer/detection-diagnosis-staging/survival-rates.html.
Accessed November 2025.
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.
|
|
AstraZeneca
PLC
|
Date:
22 December 2025
|
|
By: /s/
Matthew Bowden
|
|
|
Name:
Matthew Bowden
|
|
|
Title:
Company Secretary
|