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 December 2022
Commission File
Number: 001-11960
AstraZeneca
PLC
1
Francis Crick Avenue
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Biomedical Campus
Cambridge CB2
0AA
United
Kingdom
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AstraZeneca
PLC
INDEX
TO EXHIBITS
1. Imfinzi approved in EU for biliary tract cancer
21
December 2022 07:00 GMT
Imfinzi plus
chemotherapy approved in the EU as first
immunotherapy
regimen for patients with advanced biliary tract
cancer
Approval based on TOPAZ-1 updated survival results showing
Imfinzi
combination reduced risk of death by 24% vs. chemotherapy
alone
AstraZeneca's Imfinzi (durvalumab) has been approved in the
European Union (EU) for the 1st-line treatment of adult patients
with unresectable or metastatic biliary tract cancer (BTC) in
combination with chemotherapy (gemcitabine plus
cisplatin).
The approval by the European Commission was based
on the primary results from the TOPAZ-1 Phase III trial
published in the New
England Journal of Medicine Evidence, and on the updated results presented at
the European Society for
Medical Oncology Congress 2022.
The approval follows the recommendation by
The Committee for Medicinal Products for Human Use of the European
Medicines Agency in November 2022.
At the interim
analysis, Imfinzi plus chemotherapy reduced the risk of death
by 20% versus chemotherapy alone (based on a hazard ratio [HR] of
0.80; 95% confidence interval [CI] 0.66-0.97;
p=0.021). Updated results from TOPAZ-1 after an
additional 6.5 months of follow-up showed a 24% reduction in the
risk of death versus chemotherapy alone (HR 0.76; 95% CI,
0.64-0.91), with more than two times as many patients treated
with Imfinzi plus chemotherapy estimated to be alive at
two years versus chemotherapy alone (23.6% versus 11.5%). Updated
median overall survival (OS) was 12.9 months versus 11.3 with
chemotherapy.
BTC is a group of rare and aggressive cancers that
occur in the bile ducts (cholangiocarcinoma) and
gallbladder.1,2 There
are approximately 211,000 new patients diagnosed with gallbladder
and biliary tract cancer each year, and about 40,000 of these occur
across Europe.3 These
patients have a poor prognosis, with approximately 5% to 15% of
patients with BTC surviving five years.4
Juan
W. Valle, MD, Professor of Medical Oncology at the University of
Manchester and The Christie NHS Foundation Trust, UK, and a lead
investigator in the TOPAZ-1 Phase III trial, said: "Today's
approval marks an important shift in the treatment of this
aggressive and often overlooked disease and a significant
improvement compared to standard of care for these patients. After
waiting over a decade for new therapeutic options, biliary tract
cancer patients in the EU will now have the opportunity to benefit
from an immunotherapy-based treatment for the first
time."
Dave Fredrickson, Executive Vice President,
Oncology Business Unit, AstraZeneca, said: "With this
approval, Imfinzi plus chemotherapy becomes the only
immunotherapy-based treatment option available to patients in the
EU with advanced biliary tract cancer. This approval underscores
our commitment to transform survival outcomes while addressing the
high unmet need for new and improved treatments for patients with
hepatobiliary cancers."
Imfinzi plus chemotherapy was generally well
tolerated, with no new safety signals observed, and did not
increase the discontinuation rate due to adverse events (AEs)
compared to chemotherapy alone. Grade 3 or 4 treatment-related AEs
were experienced by 60.9% of patients treated
with Imfinzi plus chemotherapy, and by 63.5% of patients
treated with chemotherapy alone.
Imfinzi plus chemotherapy
is approved in
the US and other countries for the treatment of adults with locally
advanced or metastatic BTC. Regulatory applications are also
currently under review in Japan and several
other countries based on the TOPAZ-1 results.
Notes
Biliary tract cancer
BTC is a group of rare and aggressive
gastrointestinal (GI) cancers that form in the cells of the bile
ducts (cholangiocarcinoma), gallbladder or ampulla of Vater (where
the bile duct and pancreatic duct connect to the small
intestine).1,2
Early-stage BTC affecting the bile ducts and
gallbladder often presents without clear symptoms and most new
cases of BTC are therefore diagnosed at an advanced stage, when
treatment options are limited and the prognosis is
poor.4-6 Cholangiocarcinoma
is more common in China and Southeast Asia and is on the rise
in Western countries.1,4
TOPAZ-1
TOPAZ-1 was a randomised, double-blind, placebo
controlled, multicentre, global Phase III trial
of Imfinzi in combination with chemotherapy
(gemcitabine plus cisplatin) versus placebo in combination with
chemotherapy as a 1st-line treatment in 685 patients with
unresectable advanced or metastatic BTC including intrahepatic and
extrahepatic cholangiocarcinoma, and gallbladder cancer. Patients
with ampullary carcinoma were excluded.
The
primary endpoint was overall survival and key secondary
endpoints included progression-free survival, objective response
rate and safety. The trial was conducted in 105 centres across 17
countries including in the US, Europe, South America and several
countries in Asia including South Korea, Thailand, Japan and
China.
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 the only approved immunotherapy in
unresectable or metastatic BTC, unresectable hepatocellular
carcinoma [in combination with Imjudo (tremelimumab)], and the curative-intent
setting of unresectable, Stage III non-small cell lung cancer
(NSCLC) in patients whose disease has not progressed after
chemoradiotherapy. It is the global standard of care in this
setting 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 (ES-SCLC) based on the
CASPIAN Phase III trial. In 2021, updated results from the
CASPIAN trial showed Imfinzi plus chemotherapy tripled patient survival
at three years versus chemotherapy alone.
Imfinzi is also approved in the US for the
treatment of adult patients with Stage IV (metastatic) NSCLC
in combination with Imjudo and chemotherapy.
Imfinzi is also approved for previously treated
patients with advanced bladder cancer in several
countries.
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.
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.7
Within
this programme, the Company is committed to improving outcomes in
gastric, liver, biliary tract, oesophageal, pancreatic,
and colorectal cancers.
Imfinzi is approved in the US in combination with
chemotherapy (gemcitabine plus cisplatin) for advanced BTC and in
combination with Imjudo in unresectable hepatocellular
carcinoma. 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 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 in BRCA-mutated metastatic pancreatic
cancer. Lynparza is developed and commercialised in
collaboration with MSD (Merck & Co., Inc. inside the US
and Canada).
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 Twitter @AstraZeneca.
Contacts
For details on how to contact the Investor
Relations Team, please click here.
For Media contacts, click here.
References
1.
Marcano-Bonilla
L, et
al. Biliary
tract cancers: epidemiology, molecular pathogenesis and genetic
risk associations. CCO.
2016;5(5).
2.
ESMO.
What is Biliary Tract Cancer. Available at:
3.
https://www.esmo.org/content/download/266801/5310983/1/EN-Biliary-Tract-Cancer-Guide-for-Patients.pdf.
Accessed December 2022.
4.
Ouyang G, et al. The global, regional, and national burden of
gallbladder and biliary tract cancer and its attributable risk
factors in 195 countries and territories, 1990 to 2017: A
systematic analysis for the Global Burden of Disease Study
2017. Cancer. 2021;127:2238-2250.
5.
Turkes F, et al. Contemporary Tailored Oncology Treatment of
Biliary Tract Cancers. Gastroenterol Res
Pract. 2019;2019:7698786.
6.
Rawla P, et al. Epidemiology of gallbladder
cancer. Clin Exp
Hepatol.
2019;5(2):93-102.
7.
Banales
JM, et
al. Cholangiocarcinoma
2020: the next horizon in mechanisms and
management. Nat Rev
Gastroenterol Hepatol.
2020;17:557-588.
8.
WHO.
World Cancer Fact Sheet. Available at:
https://gco.iarc.fr/today/data/factsheets/populations/900-world-fact-sheets.pdf.
Accessed December 2022.
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:
21 December 2022
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By: /s/
Adrian Kemp
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Name:
Adrian Kemp
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Title:
Company Secretary
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