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 January 2022
Commission File
Number: 001-11960
AstraZeneca
PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge CB2
0AA
United
Kingdom
Indicate by check
mark whether the registrant files or will file annual reports under
cover of Form 20-F or Form 40-F.
Form
20-F X Form 40-F __
Indicate by check
mark if the registrant is submitting the Form 6-K in paper as
permitted by Regulation S-T Rule 101(b)(1):
Indicate by check
mark if the registrant is submitting the Form 6-K in paper as
permitted by Regulation S-T Rule 101(b)(7): ______
Indicate by check
mark whether the registrant by furnishing the information contained
in this Form is also thereby furnishing the information to the
Commission pursuant to Rule 12g3-2(b) under the Securities Exchange
Act of 1934.
Yes __
No X
If
“Yes” is marked, indicate below the file number assigned to the
Registrant in connection with Rule 12g3-2(b):
82-_____________
AstraZeneca
PLC
INDEX
TO EXHIBITS
1.
Imfinzi
improves survival in biliary tract cancer
19
January 2022 07:05 GMT
Imfinzi plus chemotherapy
reduced risk of death by 20% in 1st-line advanced biliary tract
cancer
TOPAZ-1 is the first Phase III trial to show improved
survival
with an immunotherapy combination in this setting
Combination did not increase discontinuations due to adverse events
vs. chemotherapy alone
Positive results from the TOPAZ-1 Phase III trial
showed AstraZeneca's Imfinzi (durvalumab), in combination with
standard-of-care chemotherapy, demonstrated a statistically
significant and clinically meaningful improvement in overall
survival (OS) and progression-free survival (PFS) versus
chemotherapy alone as a 1st-line treatment for patients with
advanced biliary tract cancer (BTC).
These
results will be presented on 21 January at the 2022 American
Society of Clinical Oncology (ASCO) Gastrointestinal Cancers
Symposium.
BTC is a group of rare and aggressive cancers that
occur in the bile ducts and gallbladder.1,2 Approximately
50,000 people in the US, Europe and Japan and about 210,000 people
worldwide are diagnosed with BTC each year.3-5 These
patients have a poor prognosis, with approximately 5% to 15% of all
patients with BTC surviving five years.6
Do-Youn Oh, MD, PhD, Professor, Division of
Medical Oncology, Department of Internal Medicine at Seoul National
University Hospital and Seoul National University College of
Medicine, and principal investigator in the TOPAZ-1 Phase III
trial, said: "After minimal progress for more than a decade in
advanced biliary tract cancer, the TOPAZ-1 results are a tremendous
advance for our patients, showing a clear survival benefit
for Imfinzi added to chemotherapy compared to standard
of care with a remarkable safety profile. This combination will
provide a desperately needed and potentially practice-changing new
treatment option in a setting where the current prognosis is
devastating."
Susan Galbraith, Executive Vice President,
Oncology R&D, AstraZeneca, said: "The results from the TOPAZ-1
trial challenge treatment expectations in advanced biliary tract
cancer and provide compelling evidence that longer-term survival is
possible. Overall survival improves over time with an estimated one
in four patients on Imfinzi plus chemotherapy alive at two years
compared to one in ten on chemotherapy alone. This is a
potential new standard of care for patients in this setting and we
remain committed to making advances in gastrointestinal cancers
with high unmet need."
In a predefined interim analysis, patients treated
with Imfinzi in combination with standard-of-care
chemotherapy experienced a 20% reduction in the risk of death
versus chemotherapy alone (based on a hazard ratio [HR] of 0.80;
95% confidence interval [CI], 0.66-0.97; 2-sided p=0.021). Median
OS was 12.8 months versus 11.5 for chemotherapy. An
estimated 25% of patients were still alive at two years versus
10% for chemotherapy.
Results also showed a 25% reduction in the risk of
disease progression or death with Imfinzi plus chemotherapy (HR, 0.75; 95% CI,
0.64-0.89; 2-sided p=0.001). Median PFS was 7.2 months for the
combination versus 5.7 for chemotherapy. Patients treated
with Imfinzi plus chemotherapy achieved an objective
response rate (ORR) of 26.7% versus an ORR of 18.7% for patients
treated with chemotherapy alone.
Summary of efficacy resultsi:
|
|
Imfinzi +
chemotherapy
(n=341)
|
Placebo + chemotherapy
(n=344)
|
|
OSii,iii
|
|
|
|
Percentage
of patients with event
|
58.1
|
65.7
|
|
Median
OS (95% CI) (in months)
|
12.8
(11.1, 14.0)
|
11.5
(10.1, 12.5)
|
|
HR
(95% CI)
2-sided
p-value
|
0.80
(0.66, 0.97)
0.021
|
|
OS
rate at 18 months (95% CI) (%)
|
35.1
(29.1, 41.2)
|
25.6
(19.9, 31.7)
|
|
OS
rate at 24 months (95% CI) (%)
|
24.9
(17.9, 32.5)
|
10.4
(4.7, 18.8)
|
|
PFSiv,v
|
|
|
|
Percentage
of patients with event
|
80.9
|
86.3
|
|
Median
PFS (95% CI) (in months)
|
7.2
(6.7, 7.4)
|
5.7
(5.6, 6.7)
|
|
HR
(95% CI)
2-sided
p-value
|
0.75
(0.64, 0.89)
0.001
|
|
ORR (%)
|
26.7
|
18.7
|
i.
Analysis was done at 62% maturity in OS data.
ii.
Investigator-assessed OS data cut-off date was 11 August
2021.
iii. Median
follow-up in censored patients at DCO: 13.7 months (range 0.4-27.2)
for Imfinzi plus chemotherapy, 12.6 months (range
0.7-26.0) for chemotherapy alone.
iv.
Investigator-assessed PFS data cut-off date was 11 August
2021.
v.
Median follow-up in censored patients at DCO: 9.2 months (range
0.0-24.0) for Imfinzi plus chemotherapy, 6.9 months (range
0.0-20.4) for chemotherapy alone.
Imfinzi plus chemotherapy 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 62.7% of patients treated
with Imfinzi and chemotherapy, and by 64.9% of patients
receiving chemotherapy alone. Treatment-related AEs led to
discontinuation in 8.9% of patients treated with
the Imfinzi combination versus 11.4% of patients
receiving chemotherapy.
In December 2020, Imfinzi was granted Orphan Drug Designation in the
US for the treatment of BTC. In October
2021, an Independent Data
Monitoring Committee recommended the TOPAZ-1 Phase III trial to be
unblinded at an interim analysis due to clear evidence of efficacy
for Imfinzi plus chemotherapy.
An additional presentation featured during the
ASCO Gastrointestinal Cancers Symposium will
showcase Imfinzi data from the HIMALAYA Phase III
trial, demonstrating the potential of this medicine in the
treatment of unresectable liver
cancer.
Notes
Biliary tract cancer
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
Cholangiocarcinoma is more common in China and
Thailand and is on the rise in Western
countries.1,6 Gallbladder
cancer is more common in certain regions of South America, India
and Japan.7
Apart from ampullary cancer, early-stage BTC 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.8-10
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 (ampullary
carcinoma was excluded).
The
primary endpoint was OS 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 the curative-intent setting of
unresectable, Stage III non-small cell lung cancer (NSCLC) in
patients whose disease has not progressed after chemoradiation
therapy, and 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.
Imfinzi is
also approved for previously treated patients with advanced bladder
cancer in several countries.
Since the first approval in May 2017, more than
100,000 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
small cell lung cancer, NSCLC, bladder cancer, several GI cancers,
cervical cancer, 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.11
Within
this programme, the Company is committed to improving outcomes in
gastric, liver, BTC, oesophageal, pancreatic, and colorectal
cancers.
Imfinzi is
being assessed in combinations in liver, BTC, oesophageal and
gastric cancers in an extensive development programme spanning
early to late-stage disease.
The Company aims to understand the potential
of Enhertu (trastuzumab deruxtecan), a HER2-directed
antibody drug conjugate, in colorectal and gastric cancers - the
two most common GI cancers. Enhertu is jointly developed and commercialised by
AstraZeneca and Daiichi Sankyo.
Lynparza (olaparib)
is a first-in-class PARP inhibitor with a broad and advanced
clinical trial programme across multiple GI tumour types including
pancreatic and colorectal cancers. Lynparza is developed and commercialised in
collaboration with MSD (Merck & Co., Inc. inside the US and
Canada).
AstraZeneca in immunotherapy
Immunotherapy
is a therapeutic approach designed to stimulate the body's immune
system to attack tumours. The Company's Immuno-Oncology (IO)
portfolio is anchored in immunotherapies that have been designed to
overcome anti-tumour immune suppression. AstraZeneca is invested in
using IO approaches that deliver long-term survival for new groups
of patients across tumour types.
The Company is pursuing a comprehensive
clinical-trial programme that includes Imfinzi as a single treatment and in combination
with tremelimumab and other novel antibodies in multiple tumour
types, stages of disease, and lines of treatment, and where
relevant using the PD-L1 biomarker as a decision-making tool to
define the best potential treatment path for a
patient.
In
addition, the ability to combine the IO portfolio with radiation,
chemotherapy, and targeted small molecules from across
AstraZeneca's oncology pipeline, and from research partners, may
provide new treatment options across a broad range of
tumours.
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 January 2022.
3. Siegel R, et al. Cancer Statistics. CA Cancer J
Clin. 2020; 70:
7-30.
4. Nakachi K, et al. A randomized Phase III trial of adjuvant S1
therapy vs. observation alone in resected biliary tract cancer:
Japan Clinical Oncology Group Study (JCOG1202,
ASCOT). Japanese Journal of Clinical
Oncology. 2018; 48(4):
392-395.
5. GBD 2017 Disease and Injury Incidence and
Prevalence Collaborators. Global, regional, and national incidence,
prevalence, and years lived with disability for 354 diseases and
injuries for 195 countries and territories, 1990-2017: a systematic
analysis for the Global Burden of Disease Study
2017. Lancet. 2018;392(10159):1789-1858.
6. Turkes F, et al. Contemporary Tailored Oncology Treatment of
Biliary Tract Cancers. Gastroenterol Res
Pract. 2019;
2019:7698786.
7. Rawla P, et al. Epidemiology of gallbladder
cancer. Clin Exp
Hepatol. 2019; 5(2):
93-102.
8. Banales JM, et al. Cholangiocarcinoma 2020: the next horizon in
mechanisms and management. Nature Reviews
Gastroenterology & Hepatology. 2020; 17: 557-588.
9.
Mehrotra B. Gallbladder cancer: Epidemiology, risk factors,
clinical features, and diagnosis. Available at:
https://www.uptodate.com/contents/gallbladder-cancer-epidemiology-risk-factors-clinical-features-and-diagnosis.
Accessed January 2022.
10. He XD, et al. Association of metabolic syndromes and risk
factors with ampullary tumors development: A case-control study in
China. World J
Gastroenterol. 2014; 20(28):
9541-9548.
11.
WHO. World Cancer Fact Sheet. Available at: https://gco.iarc.fr/today/data/factsheets/populations/900-world-fact-sheets.pdf.
Accessed January 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:
19 January 2022
|
|
By: /s/
Adrian Kemp
|
|
|
Name:
Adrian Kemp
|
|
|
Title:
Company Secretary
|
AstraZeneca (NYSE:AZN)
Historical Stock Chart
Von Apr 2022 bis Mai 2022
AstraZeneca (NYSE:AZN)
Historical Stock Chart
Von Mai 2021 bis Mai 2022
