a2282g
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 2022
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 recommended for approval in the EU for BTC
14
November 2022 07:05 GMT
Imfinzi plus chemotherapy recommended
for approval in the EU by CHMP as
first immunotherapy regimen for advanced biliary tract
cancer
Positive opinion based on TOPAZ-1 Phase III trial updated survival
results showing Imfinzi combination reduced risk of death by 24%
vs. chemotherapy alone
AstraZeneca's Imfinzi (durvalumab) has been recommended for
marketing authorisation 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
Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency based its positive opinion 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.
At
the interim
analysis, Imfinzi plus chemotherapy reduced
the risk of death by 20% versus chemotherapy alone (hazard ratio
[HR] 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 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
and gallbladder.1,2 There are
approximately 210,000 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, UK, and a lead investigator in the TOPAZ-1 Phase III
trial, said: "This positive opinion is welcome news for patients
with advanced biliary tract cancer in the European Union who face a
poor prognosis and limited treatment options. The combination of
durvalumab and chemotherapy is a significant advance for patients
after more than a decade of limited progress, and this regimen
should become a new standard of care option once
approved."
Susan Galbraith, Executive Vice President, Oncology R&D,
AstraZeneca, said: "If approved, Imfinzi plus chemotherapy will provide patients with
advanced biliary tract cancer the first opportunity for treatment
with an immunotherapy-based combination. This innovative regimen
has been shown to significantly prolong patients' lives, and we
look forward to bringing this option to those in the European Union
as soon as possible."
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 and chemotherapy, and by
63.5% of patients treated with chemotherapy alone.
Imfinzi plus chemotherapy is approved in
the US, Canada, South Korea and Brazil for the treatment of
patients 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
is 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 is 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 also the only approved immunotherapy in
unresectable or metastatic biliary tract cancer and hepatocellular
carcinoma [in combination with Imjudo (tremelimumab)]. It is also
approved in combination with Imjudo and chemotherapy in
metastatic non-small cell lung cancer (NSCLC) and in the
curative-intent setting of unresectable, Stage III 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 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 and several other
countries in combination with chemotherapy (gemcitabine plus
cisplatin) for advanced biliary tract cancer and in the US in
combination with Imjudo (tremelimumab) 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 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 in immuno-oncology (IO)
AstraZeneca
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:
https://www.esmo.org/content/download/266801/5310983/1/EN-Biliary-Tract-Cancer-Guide-for-Patients.pdf.
Accessed November 2022.
3.
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.
4. Turkes
F, et
al.
Contemporary Tailored Oncology Treatment of Biliary Tract
Cancers. Gastroenterol
Res Pract. 2019;2019:7698786.
5.
Rawla P, et al.
Epidemiology of gallbladder cancer. Clin Exp Hepatol.
2019;5(2):93-102.
6. Banales JM, et al. Cholangiocarcinoma 2020: the next horizon in
mechanisms and management. Nat Rev Gastroenterol
Hepatol.
2020;17:557-588.
7. WHO.
World Cancer Fact Sheet. Available at:
https://gco.iarc.fr/today/data/factsheets/populations/900-world-fact-sheets.pdf.
Accessed November 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:
14 November 2022
|
By: /s/
Adrian Kemp
|
|
Name:
Adrian Kemp
|
|
Title:
Company Secretary
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