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 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.
Imfinzi+Imjudo improves PFS in early liver cancer
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
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
click here.
For Media contacts, click here.
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
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.
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AstraZeneca
PLC
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Date: 02 April 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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