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 November 2023
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 combination improves PFS in liver cancer
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
embolisation.
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
For details on how to contact the Investor Relations Team, 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
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.
Date: 9
November 2023
|
By: /s/
Adrian Kemp
|
|
Name:
Adrian Kemp
|
|
Title:
Company Secretary
|
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