TIDMAZN
RNS Number : 8660S
AstraZeneca PLC
09 November 2023
09 November 2023
Imfinzi plus bevacizumab met primary endpoint for
progression-free survival in liver cancer eligible for embolisation
in EMERALD-1 Phase III trial
First global Phase III trial to show improved clinical outcome
for systemic therapy
in combination with transarterial chemoembolisation (TACE) in
this setting
Positive high-level results from the EMERALD-1 Phase III trial
showed AstraZeneca's Imfinzi (durvalumab) in combination with
transarterial chemoembolisation (TACE) and bevacizumab demonstrated
a statistically significant and clinically meaningful improvement
in the primary endpoint of progression-free survival (PFS) versus
TACE alone in patients with hepatocellular carcinoma (HCC) eligible
for embolisation. The trial continues to follow the secondary
endpoint of overall survival (OS).
Liver cancer, of which HCC is the most common type, is the
third-leading cause of cancer death with an estimated 900,000
people worldwide diagnosed each year.(1,2) Approximately 20-30% of
patients are eligible for embolisation, a procedure that blocks the
blood supply to the tumour and can also deliver chemotherapy or
radiation therapy directly to the liver.(3-9) Despite being the
standard of care in this setting, most patients who receive
embolisation experience rapid disease progression or
recurrence.(10-14)
Dr. Riccardo Lencioni, Professor and Director of the Cancer
Imaging Program in the Department of Diagnostic and Interventional
Radiology of Pisa University Hospital in Pisa, Italy, and principal
investigator in the trial, said: "Patients with liver cancer
eligible for embolisation experience high rates of progression or
recurrence and do not have the opportunity for early intervention
with effective systemic therapy. These results for durvalumab plus
bevacizumab have the potential to reshape the treatment of this
complex disease with a poor prognosis by showing for the first time
that adding an immunotherapy combination to TACE significantly
improves progression-free survival."
Susan Galbraith, Executive Vice President, Oncology R&D,
AstraZeneca, said: "These positive results for Imfinzi-based
treatment in EMERALD-1 may bring the potential of immunotherapy to
patients with earlier stages of liver cancer. We look forward to
discussing these data with regulatory authorities and seeing the
survival data mature over time, which will be important as we aim
to bring this novel treatment option to patients."
The safety profiles for Imfinzi and TACE plus bevacizumab were
consistent with the known profile of each medicine, and there were
no new safety findings.
The data will be presented at a forthcoming medical meeting and
shared with regulatory authorities.
AstraZeneca has an extensive clinical development programme
further assessing Imfinzi across multiple gastrointestinal (GI)
cancer settings, including in combination with bevacizumab in
adjuvant HCC (EMERALD-2) and in combination with Imjudo
(tremelimumab), lenvatinib and TACE in embolisation-eligible HCC
(EMERALD-3).
Notes
Liver cancer
Liver cancer is the third-leading cause of cancer death and the
sixth most commonly diagnosed cancer worldwide.(1-2) Asia holds
more than 70% of the world's new liver cancer cases.(15) About 75%
of all primary liver cancers in adults are HCC.(1) Between 80-90%
of all patients with HCC also have cirrhosis.(16) Chronic liver
diseases such as cirrhosis are associated with inflammation that
over time can lead to the development of HCC.(16) Immunotherapy is
a proven treatment modality in HCC with approved options available
for patients in later-line settings.(17)
EMERALD-1
EMERALD-1 is a randomised, double-blind, placebo-controlled,
multicentre, global Phase III trial of Imfinzi plus TACE
concurrently, followed by Imfinzi with or without bevacizumab until
progression versus TACE alone in a total of 616 patients with
unresectable HCC eligible for em bolisation.
The trial was conducted in 157 centres across 18 countries,
including in North America, Australia, Europe, South America and
Asia. The primary endpoint was PFS for Imfinzi and TACE plus
bevacizumab versus TACE alone, and secondary endpoints include PFS
for Imfinzi plus TACE, overall survival, patient-reported outcomes
and objective response rate.
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.
Imfinzi is approved in combination with chemotherapy
(gemcitabine plus cisplatin) in locally advanced or metastatic
biliary tract cancer (BTC) and in combination with Imjudo
(tremelimumab) in unresectable HCC in the US, EU, Japan and many
other countries based on the TOPAZ-1 and HIMALAYA Phase III trials,
respectively.
In addition to its indications in GI cancers, Imfinzi is the
only approved immunotherapy and the global standard of care in the
curative-intent setting of unresectable, Stage III non-small cell
lung cancer (NSCLC) in patients whose disease has not progressed
after chemoradiation therapy based on the PACIFIC Phase III
trial.
Imfinzi is also approved in the US, EU, Japan, China and many
other countries around the world for the treatment of
extensive-stage small-cell lung cancer (SCLC) based on the CASPIAN
Phase III trial. Additionally, Imfinzi is approved in combination
with a short course of Imjudo and chemotherapy for the treatment of
metastatic NSCLC in the US, EU and Japan based on the POSEIDON
Phase III trial. Imfinzi is approved in previously treated patients
with advanced bladder cancer in a small number of countries.
Since the first approval in May 2017, more than 200,000 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 SCLC, NSCLC, bladder
cancer, several GI cancers, ovarian cancer, endometrial cancer and
other solid tumours. In 2023, AstraZeneca announced positive
results for Phase III trials including combinations with Imfinzi in
ovarian (DUO-O) and endometrial (DUO-E) cancers, as well as in
resectable NSCLC (AEGEAN).
In addition to the EMERALD programme across multiple liver
cancer settings, AstraZeneca has ongoing registrational trials
investigating Imfinzi in resectable gastric and gastroesophageal
junction cancers (MATTERHORN) and in locally advanced oesophageal
cancer (KUNLUN). In June 2023, Imfinzi added to standard-of-care
neoadjuvant chemotherapy met a key secondary endpoint of pathologic
complete response in the MATTERHORN Phase III trial.
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 2020, GI cancers collectively
represented approximately 5.1 million new cancer cases leading to
approximately 3.6 million deaths.(18)
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 liver,
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, is approved in the US and several other countries for
HER2-positive advanced gastric cancer and is being assessed in
colorectal cancer. Enhertu is jointly developed and commercialised
by AstraZeneca and Daiichi Sankyo.
Lynparza (olaparib), a first-in-class PARP inhibitor, is
approved 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).
AstraZeneca also recently entered into a global exclusive
license agreement with KYM Biosciences Inc. for AZD0901. AZD0901 is
a potential first-in-class antibody drug conjugate targeting
Claudin 18.2, a promising therapeutic target in gastric cancer,
currently in Phase I development.
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 aims to reimagine cancer care and help transform
outcomes for patients with Imfinzi as a single treatment and in
combination with Imjudo as well as other novel immunotherapies and
modalities. The Company is also exploring next-generation
immunotherapies like bispecific antibodies and therapeutics that
harness different aspects of immunity to target cancer.
AstraZeneca is boldly 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. 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 operates in over
100 countries and its innovative medicines are used by millions of
patients worldwide. Please visit astrazeneca.com and follow the
Company on social media @AstraZeneca .
Contacts
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please click here . For Media contacts, click here .
References
1. ASCO. Liver Cancer: View All Pages. Available at: https://www.cancer.net/cancer-types/liver-cancer/view-all. Accessed November 2023.
2. WHO. Liver Cancer Fact Sheet. Available at: https://gco.iarc.fr/today/data/factsheets/cancers/11-Liver-fact-sheet.pdf . Accessed November 2023.
3. Lin Y-J, et al. Treatment patterns and survival in
hepatocellular carcinoma in the United States and Taiwan. PLoS ONE.
2020;15(10):e0240542.
4. Park J-W, et al. Global patterns of hepatocellular carcinoma
management from diagnosis to death: the BRIDGE Study. Liver Int.
2015;35(9):2155-2166.
5. Henriksson M, et al. Treatment patterns and survival in
patients with hepatocellular carcinoma in the Swedish national
registry SweLiv. BJS Open. 2020;4(1):109-117.
6. Wehling C, et al. Treatment stage migration and treatment
sequences in patients with hepatocellular carcinoma: drawbacks and
opportunities. J Cancer Res Clin Oncol. 2021;147(8):2471-2481.
7. Fukuda H, et al. Differences in healthcare expenditure
estimates according to statistical approach: A nationwide claims
database study on patients with hepatocellular carcinoma. PLoS ONE.
2020;15(8):e0237316.
8. Akada K, et al. Database analysis of patients with
hepatocellular carcinoma and treatment flow in early and advanced
stages. Pharmacol Res Perspect. 2019;7(4):e00486.
9. Chon YE, et al. Hepatocellular Carcinoma in Korea between
2012 and 2014: an Analysis of Data from the Korean Nationwide
Cancer Registry. J Liver Cancer. 2020;20(2):135-147.
10. Cerban R, et al. Predictive Factors of Tumor Recurrence and
Survival in Patients with Hepatocellular Carcinoma treated with
Transarterial Chemoembolization. J Gastrointestin Liver Dis. 2018
Dec;27(4):409-417.
11. Lencioni R, et al. Sorafenib or placebo plus TACE with
doxorubicin-eluting beads for intermediate stage HCC: The SPACE
trial. J Hepatol. 2016 May;64(5):1090-1098.
12. Golfieri R, et al. Hepatocellular carcinoma responding to
superselective transarterial chemoembolization: an issue of nodule
dimension? J Vasc Interv Radiol. Apr;24(4):509-17.
13. Kudo M, et al. Brivanib as adjuvant therapy to transarterial
chemoembolization in patients with hepatocellular carcinoma: A
randomized phase III trial. Hepatology. v;60(5):1697-707.
14. Lencioni R, et al. Lipiodol transarterial chemoembolization
for hepatocellular carcinoma: A systematic review of efficacy and
safety data. Hepatology, 2016;64: 106-116.
15. Liu Y, et al. Changes in the Epidemiology of Hepatocellular
Carcinoma in Asia. Cancers (Basel). 2022;14(18):4473.
16. Tarao K, et al. Real impact of liver cirrhosis on the
development of hepatocellular carcinoma in various liver
diseases-meta -- analytic assessment. Cancer Med.
2019;8(3):1054-1065.
17. Colagrande S, et al. Challenges of advanced hepatocellular
carcinoma. World J Gastroenterol. 2016;22(34):7645-7659.
18. World Health Organisation. World Fact Sheet. Available at:
https://gco.iarc.fr/today/data/factsheets/populations/900-world-fact-sheets.pdf.
Accessed November 2023.
Adrian Kemp
Company Secretary
AstraZeneca PLC
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