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 March 2022
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
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to the Commission pursuant to Rule 12g3-2(b) under the Securities
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
Update on CALLA Phase III trial of concurrent use
of Imfinzi
and chemoradiotherapy in locally advanced cervical
cancer
24
March 2022 07:00 GMT
Update on CALLA Phase III trial of concurrent use of Imfinzi
and chemoradiotherapy in locally advanced cervical
cancer
The
CALLA Phase III trial for AstraZeneca’s Imfinzi (durvalumab) given concurrently
with chemoradiotherapy (CRT) did not achieve statistical
significance for the primary endpoint of improving progression-free
survival (PFS) versus CRT alone in the treatment of patients with
locally advanced cervical cancer.
Bradley
Monk, MD, FACOG, FACS, Professor at the University of Arizona
College of Medicine and principal investigator in the CALLA Phase
III trial, said: “While today’s results were not
statistically significant, they underscore the need for further
evaluation of novel therapeutic options and will inform future
strategies to improve treatment for patients with locally advanced
cervical cancer.”
Susan
Galbraith, Executive Vice President, Oncology R&D, AstraZeneca,
said: “CALLA tested a novel immunotherapy approach in locally
advanced cervical cancer, a devastating and complex disease where
many patients progress following available treatments. While the
results were not what we hoped for, insights from the trial will
advance our understanding and application of immunotherapy across
our broad clinical development programme, exploring the benefits of
Imfinzi in many tumour
types.”
The
safety and tolerability in this trial were consistent between the
two arms and no new unexpected safety findings were observed. The
data will be presented at a forthcoming medical
meeting.
Notes
Locally advanced cervical cancer
Cervical
cancer is the eighth most common, and ninth most deadly, cancer
worldwide, with approximately 600,000 people diagnosed each
year.1
Approximately 40-50% of cervical cancer cases are diagnosed in the
locally advanced stage.2 Following current
standard-of-care treatment, platinum-based chemotherapy with
radiation therapy, patients with locally advanced cervical cancer
face an approximately 40% chance of disease recurrence and a
five-year survival rate of about 65-70%.2,3 The
standard-of-care treatment for these patients has not changed in
over two decades.4
CALLA
CALLA
is a randomised, multi-centre, double-blind, global Phase III trial
in which 770 patients with locally advanced cervical cancer were
treated with standard-of-care CRT in combination with either a
1,500mg fixed dose of Imfinzi or placebo every four weeks for
up to 24 cycles or until disease progression.
The
trial was conducted at 120 centres across 15 countries including in
the US, Europe, Latin America, Africa and Asia. The primary
endpoint was PFS and key secondary endpoints included overall
survival and safety and tolerability. For more information about
the trial, please visit Clinicaltrials.gov.
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 chemoradiotherapy, 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 based on the CASPIAN Phase
III trial.
In the past year, Imfinzi has demonstrated clinical
benefit in multiple additional cancer settings with positive Phase
III trials in advanced biliary tract cancer (TOPAZ-1), unresectable
advanced liver cancer (HIMALAYA) and metastatic NSCLC
(POSEIDON).
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 gastrointestinal cancers, ovarian cancer, endometrial
cancer and other solid tumours.
AstraZeneca in immuno-oncology
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 evasion of the anti-tumour immune
response. 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.
World Health
Organization. Globocan 2020. World fact sheet. Available at:
https://gco.iarc.fr/today/data/factsheets/populations/900-world-fact-sheets.pdf.
Accessed March 2022.
2.
Gennigens C,
et al. Optimal treatment in
locally advanced cervical cancer. Expert Rev Anticancer Ther.
2021;21(6):657-671.
3.
Espenel S,
et al. From IB2 to IIIB
locally advanced cervical cancers: report of a ten-year experience.
Radiat Oncol.
2018;13(16):1-11.
4.
Marth C,
et al. Cervical cancer:
ESMO Clinical Practice Guidelines for diagnosis, treatment and
follow-up. Annals of
Oncology 2017; 28 (4):IV72-IV83.
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:
24 March 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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