REG - AstraZeneca PLC - Update on LATIFY Phase III trial of ceralasertib

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RNS Number : 3756M  AstraZeneca PLC  22 December 2025

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 (http://www.astrazeneca.com/) and follow the
Company on Social Media @AstraZeneca
(https://www.linkedin.com/company/astrazeneca) .

Contacts

For details on how to contact the Investor Relations Team, please click here
(https://www.astrazeneca.com/investor-relations/contacts-information.html) .
For Media contacts, click here
(https://www.astrazeneca.com/media-centre/contacts.html) .

 

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
(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
(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
(https://www.cancer.org/cancer/types/lung-cancer/detection-diagnosis-staging/survival-rates.html)
. Accessed November 2025.

 

Matthew Bowden

Company Secretary

AstraZeneca PLC

 

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