REG - AstraZeneca PLC - Imfinzi+Imjudo improves PFS in early liver cancer

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RNS Number : 2330Z  AstraZeneca PLC  02 April 2026

2 April 2026

 Imfinzi plus Imjudo combined with lenvatinib and TACE demonstrated a
statistically significant and clinically meaningful improvement in
progression-free survival in embolisation-eligible unresectable liver cancer
in EMERALD-3 Phase III trial

Imfinzi plus Imjudo combined with lenvatinib and transarterial
chemoembolisation (TACE) showed trend toward improved overall survival

 

 

Positive high-level results from the EMERALD-3 Phase III trial showed
AstraZeneca's Imfinzi (durvalumab) in combination with Imjudo (tremelimumab),
lenvatinib and transarterial chemoembolisation (TACE) demonstrated a
statistically significant and clinically meaningful improvement in the primary
endpoint of progression-free survival (PFS) versus TACE alone for patients
with unresectable hepatocellular carcinoma (HCC) eligible for embolisation.

 

At this interim analysis for overall survival (OS), a key secondary endpoint,
this combination also demonstrated a trend toward OS improvement versus TACE
alone.

 

Patients in the investigational arms were treated with the STRIDE regimen
(Single Tremelimumab Regular Interval Durvalumab), with or without lenvatinib,
before TACE, and then alongside TACE.

 

Although not formally tested at this time, data for the treatment arm
evaluating the STRIDE regimen plus TACE versus TACE alone showed strong trends
toward improved PFS and OS. The trial will continue to follow OS and other key
secondary endpoints in both investigational arms.

 

HCC is the most common type of liver cancer.(1) In 2026, more than 200,000
patients with HCC will be eligible for embolisation, a standard-of-care
procedure that blocks the blood supply to the tumour and can also deliver
chemotherapy directly to the liver.(2-4) However, most patients who receive
embolisation experience disease progression or recurrence within six to ten
months.(5)

 

Ghassan Abou-Alfa, MD, JD, MBA, PhD(hc), Attending Physician, Professor of
Medicine at Memorial Sloan Kettering Cancer Center, and principal investigator
in the trial said, "Dual immunotherapy with durvalumab and tremelimumab in the
STRIDE regimen represents a meaningful advance for patients with
embolisation-eligible liver cancer, who currently lack systemic treatment
options to keep their cancer from progressing or recurring, with a trend of
improving survival. EMERALD‑3 shows we can now significantly reduce the risk
of disease progression with STRIDE as the immunotherapy backbone alongside
lenvatinib and TACE."

 

Susan Galbraith, Executive Vice President, Oncology Haematology R&D,
AstraZeneca, said: "EMERALD‑3 now shows that bringing the dual immunotherapy
STRIDE regimen earlier, alongside TACE and lenvatinib, can further improve
outcomes in earlier‑stage liver cancer. This builds on the HIMALAYA Phase
III trial data in patients with advanced, unresectable disease, where the
STRIDE regimen has already demonstrated durable overall survival benefit. We
are discussing these positive data with global regulatory authorities while
awaiting the final results from the key secondary endpoints."

 

The safety profile for each combination was consistent with the known profiles
of each medicine, and there were no new safety findings.

 

These data will be presented at a forthcoming medical meeting and shared with
global regulatory authorities.

 

+++

 

Notes

 

Liver cancer

Liver cancer, of which HCC is the most common type, is the third-leading cause
of cancer death.(1,6) In 2026, more than 200,000 patients will be diagnosed
with embolisation-eligible HCC.(2) Embolisation is a standard-of-care
procedure that blocks the blood supply to the tumour and can also deliver
chemotherapy directly to the liver.(3-4)

 

Immunotherapy is a proven treatment modality in HCC with approved options
available for patients in later-line settings.(7)

 

EMERALD-3

EMERALD-3 is a randomised, open-label, sponsor-blinded, multicentre, global
Phase III trial of a single priming dose of Imjudo 300mg added to Imfinzi
1500mg followed by Imfinzi every four weeks (STRIDE regimen) plus TACE with or
without lenvatinib versus TACE alone in a total of 760 patients with
unresectable HCC eligible for embolisation.

 

Participants were randomised in a 1:1:1 ratio to Arm A (TACE, Imfinzi, Imjudo,
lenvatinib), Arm B (TACE, Imfinzi, Imjudo) and Arm C (TACE) until each arm
reached 175 participants. Randomisation was then continued in a 1:1 ratio to
treatment Arms A and C until each reached approximately 275 participants.
Patients received Imfinzi with Imjudo, plus TACE as needed, with or without
lenvatinib concurrently, followed by Imfinzi with or without lenvatinib until
progression.

 

The trial was conducted in 171 centres across 22 countries, including in North
America, Europe, South America and Asia. The primary endpoint is PFS for
Imfinzi plus Imjudo, lenvatinib and TACE versus TACE alone. Secondary
endpoints include OS for Imfinzi plus Imjudo, lenvatinib and TACE, and PFS and
OS for Imfinzi plus Imjudo and TACE versus TACE alone.

 

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 gastrointestinal (GI) cancer, Imfinzi is approved in combination with
chemotherapy in locally advanced or metastatic biliary tract cancer (BTC) and
in combination with Imjudo in unresectable HCC. Imfinzi is also approved as a
monotherapy in unresectable HCC in Japan and the EU.

 

In addition to its indications in GI cancers, Imfinzi is the global standard
of care based on OS in the curative-intent setting of unresectable, Stage III
non-small cell lung cancer (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 and
chemotherapy for the treatment of metastatic NSCLC. Imfinzi is also approved
for limited-stage small cell lung cancer (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.

 

Perioperative Imfinzi in combination with neoadjuvant chemotherapy is approved
in the US, EU, Japan and other countries for patients with muscle-invasive
bladder cancer based on results from the NIAGARA Phase III trial.
Additionally, in May 2025, Imfinzi added to Bacillus Calmette-Guérin
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 GI cancers.

 

Imjudo

Imjudo (tremelimumab) is a human monoclonal antibody that targets the activity
of cytotoxic T-lymphocyte-associated protein 4 (CTLA-4). Imjudo blocks the
activity of CTLA-4, contributing to T-cell activation, priming the immune
response to cancer and fostering cancer cell death. In addition to its
approved indications in liver and lung cancers, Imjudo is being tested in
combination with Imfinzi across multiple tumour types including in SCLC
(ADRIATIC) and bladder cancer (VOLGA and NILE).

 

AstraZeneca in GI cancers

AstraZeneca has a broad development programme for the treatment of GI cancers
across several medicines and a variety of tumour types and stages of disease.
In 2022, GI cancers collectively represented approximately 5 million new
cancer cases leading to approximately 3.3 million deaths.(8)

 

Within this programme, the Company is committed to improving outcomes in
gastric, liver, biliary tract, oesophageal, pancreatic and colorectal cancers.

 

In addition to its indications in BTC and HCC, Imfinzi is being assessed in
combinations, including with Imjudo, in oesophageal and gastric cancers in an
extensive development programme spanning early to late-stage disease across
settings.

 

Enhertu (trastuzumab deruxtecan), a HER2-directed antibody drug conjugate
(ADC), is approved in the US and several other countries for HER2-positive
advanced gastric cancer. Enhertu is jointly developed and commercialised by
AstraZeneca and Daiichi Sankyo.

 

Lynparza, a first-in-class PARP inhibitor, is approved in the US and several
other countries for the treatment of BRCA-mutated metastatic pancreatic
cancer. Lynparza is developed and commercialised in collaboration with MSD
(Merck & Co., Inc. inside the US and Canada).

 

The Company is also assessing rilvegostomig, a PD-1/TIGIT bispecific antibody,
in combination with chemotherapy as an adjuvant therapy in BTC, in combination
with bevacizumab with or without Imjudo as a 1st-line treatment in patients
with advanced HCC, and as a 1st-line treatment in patients with HER2-negative,
locally advanced unresectable or metastatic gastric and gastroesophageal
junction cancers. Rilvegostomig is also being evaluated in combination with
Enhertu in previously untreated, HER2-expressing, locally advanced or
metastatic BTC.

 

AstraZeneca is advancing multiple modalities that provide complementary
mechanisms for targeting Claudin 18.2, a promising therapeutic target in
gastric cancer. These include sonesitatug vedotin, a potential first-in-class
ADC licensed from KYM Biosciences Inc., currently in Phase III development;
AZD5863, a novel Claudin 18.2/CD3 T-cell engager bispecific antibody licensed
from Harbour Biomed in Phase I development; and AZD4360, an ADC, currently
being evaluated in a Phase I/II trial in patients with advanced solid tumours.

 

In early development, AstraZeneca is developing AZD7003, a Glypican 3 (GPC3)
armoured CAR T, in HCC.

 

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 (https://www.astrazeneca.com/)

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 (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.html#Contacts) . For Media
contacts, click here (https://www.astrazeneca.com/media-centre/contacts.html)
.

 

References

1.   American Cancer Society. What is Liver Cancer? Available at:
https://www.cancer.org/cancer/types/liver-cancer/about/what-is-liver-cancer.html.
Accessed April 2026.

2.   AstraZeneca PLC. Investor Relations Epidemiology Spreadsheet. Top 8
Countries. Available at:

https://www.astrazeneca.com/investor-relations.html. Accessed April 2026.

3.   National Cancer Institute. Embolization. Available at:
https://www.cancer.gov/publications/dictionaries/cancer-terms/def/embolization.
Accessed April 2026.

4.   Kotsifa E, et al. Transarterial Chemoembolization for Hepatocellular
Carcinoma: Why, When, How? J Pers Med.2022;12(3):436.

5.   Meyer T, et al. Sorafenib in combination with transarterial
chemoembolisation in patients with unresectable hepatocellular carcinoma (TACE
2): a randomised placebo-controlled, double-blind, phase 3 trial. Lancet
Gastroenterol Hepatol. 2017;2(8):565-575.

6.   World Health Organization. Liver Cancer Fact Sheet. Available at:
https://gco.iarc.fr/today/data/factsheets/cancers/11-Liver-fact-sheet.pdf.
Accessed April 2026.

7.   Colagrande S, et al. Challenges of advanced hepatocellular
carcinoma. World J Gastroenterol. 2016;22(34):7645-7659.

8.   World Health Organization. World Fact Sheet. Available at:
https://gco.iarc.who.int/media/globocan/factsheets/populations/900-world-fact-sheet.pdf.
Accessed April 2026.

 

Dr. Abou-Alfa provides consulting and advisory services to AstraZeneca.

 

Matthew Bowden

Company Secretary

AstraZeneca PLC

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