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 April 2022
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
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by check mark whether the registrant files or will file annual
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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.
Tremelimumab US Priority Review for
Imfinzi combo
25 April 2022 07:00 BST
Tremelimumab accepted under Priority Review in the US for
patients
with unresectable liver cancer in
combination with Imfinzi
STRIDE regimen of a single priming dose of tremelimumab added to
Imfinzi is the first dual immune checkpoint blockade regimen to
improve overall survival in a Phase III trial in this
setting
AstraZeneca's Biologics License Application (BLA) for tremelimumab
has been accepted for Priority Review in the US, supporting the
indication of a single priming dose of the anti-CTLA4 antibody
added to Imfinzi (durvalumab)
for the treatment of patients with unresectable hepatocellular
carcinoma (HCC). A supplemental BLA (sBLA) has also been submitted
for Imfinzi in
this indication. This novel dose and schedule of the combination is
called the STRIDE regimen (Single Tremelimumab Regular Interval
Durvalumab).
The Prescription Drug User Fee Act date, the Food and Drug
Administration (FDA) action date for their regulatory decision, is
during the fourth quarter of 2022 following the use of a priority
review voucher.
Liver cancer, of which HCC is the most common type, is the
third-leading cause of cancer death and the sixth most commonly
diagnosed cancer worldwide.1,2 Approximately
26,000 people in the US present with advanced, unresectable HCC
each year.3
Susan Galbraith, Executive Vice President,
Oncology R&D, AstraZeneca, said: "The HIMALAYA Phase III trial
showed an unprecedented three-year overall survival in this setting
with a single priming dose of tremelimumab added
to Imfinzi, highlighting the potential for this regimen to
improve longer-term survival outcomes. Patients with advanced liver
cancer are in great need of new treatment options, and we are
working closely with the FDA to bring this novel approach to
patients in the US as soon as possible."
The BLA for tremelimumab and sBLA for Imfinzi are
based on final results from
the HIMALAYA Phase III trial presented at the 2022 American Society
of Clinical Oncology Gastrointestinal Cancers
Symposium.
In this trial, patients treated with the STRIDE regimen experienced
a 22% reduction in the risk of death versus sorafenib (based on a
hazard ratio [HR] of 0.78, 96.02% confidence interval [CI]
0.65-0.93; p=0.0035).4 Nearly
one in three (31%) patients were still alive at three years versus
one in five (20%) for sorafenib.4
The safety profiles of the STRIDE regimen and
for Imfinzi alone
were consistent with the known profiles of each medicine, and no
new safety signals were identified.
Imfinzi and tremelimumab
were granted Orphan Drug Designation in the US for the treatment of
HCC in January
2020.
As part of its extensive clinical development programme in
gastrointestinal (GI) cancers, AstraZeneca is further
assessing Imfinzi across multiple liver cancer settings,
including locoregional HCC (EMERALD-1, EMERALD-3) and adjuvant HCC
(EMERALD-2).
Notes
Liver Cancer
About 75% of all primary liver cancers are HCC.1 Between
80-90% of all patients with HCC also have
cirrhosis.5 Chronic
liver diseases are associated with inflammation that over time can
lead to the development of HCC.5
More than half of patients are diagnosed at advanced stages of the
disease, often when symptoms first appear.6 A
critical unmet need exists for patients with HCC who face limited
treatment options.6 The
unique immune environment of liver cancer provides clear rationale
for investigating medications that harness the power of the immune
system to treat HCC.6
HIMALAYA
HIMALAYA was a randomised, open-label, multicentre, global Phase
III trial of Imfinzi monotherapy
and the STRIDE regimen, comprising a single priming dose of
tremelimumab 300mg added to Imfinzi 1500mg
followed by Imfinzi every
four weeks versus sorafenib, a standard-of-care multi-kinase
inhibitor.
The trial included a total of 1,324 patients with unresectable,
advanced HCC who had not been treated with prior systemic therapy
and were not eligible for locoregional therapy (treatment localised
to the liver and surrounding tissue).
The trial was conducted in 181 centres across 16 countries,
including in the US, Canada, Europe, South America and Asia. The
primary endpoint is overall survival (OS) for STRIDE versus
sorafenib and key secondary endpoints included OS
for Imfinzi versus
sorafenib, objective response rate and progression-free survival
(PFS) for STRIDE and for Imfinzi alone.
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 tumourÕs 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
(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.
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.
Tremelimumab
Tremelimumab is a human monoclonal antibody and potential new
medicine that targets the activity of cytotoxic
T-lymphocyte-associated protein 4 (CTLA-4). Tremelimumab blocks the
activity of CTLA-4, contributing to T-cell activation, priming the
immune response to cancer and fostering cancer cell
death.
Beyond HIMALAYA, tremelimumab is being tested in combination
with Imfinzi across
multiple tumour types including locoregional HCC (EMERALD-3), SCLC
(ADRIATIC) and bladder cancer (VOLGA and NILE).
Tremelimumab is also under review by global regulatory authorities
in combination with Imfinzi and chemotherapy in 1st-line metastatic
NSCLC based on the results of the POSEIDON Phase III trial, which
showed the addition of a short course of tremelimumab
to Imfinzi plus chemotherapy improved both overall and
progression-free survival compared to chemotherapy
alone.
AstraZeneca in GI cancers
AstraZeneca has a broad development programme for the treatment of
GI cancers across several medicines spanning a variety of tumour
types and stages of disease. In 2020, GI cancers collectively
represented approximately 5.1 million new diagnoses 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 (durvalumab) is being
assessed in combinations including with tremelimumab in HCC,
biliary tract, oesophageal and gastric cancers in an extensive
development programme spanning early to late-stage disease across
settings. In January 2022, results of the TOPAZ-1
Phase III trial in 1st-line advanced
biliary tract cancer demonstrated a significant improvement in OS
with Imfinzi plus
standard-of-care chemotherapy versus chemotherapy
alone.
The Company aims to understand the potential
of Enhertu (trastuzumab deruxtecan), a HER2-directed
antibody drug conjugate, in the two most common GI cancers,
colorectal and gastric 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 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.
ASCO. Liver Cancer: View All Pages. Available at:
https://www.cancer.net/cancer-types/liver-cancer/view-all. Accessed
March 2022.
2.
WHO. Liver Cancer Fact Sheet. Available at:
https://gco.iarc.fr/today/data/factsheets/cancers/11-Liver-fact-sheet.pdf.
Accessed March 2022.
3.
AstraZeneca data on file. Kantar Health. 2021.
4. Abou-Alfa
GK, et
al. Phase 3 randomized,
open-label, multicenter study of tremelimumab and durvalumab as
first-line therapy in patients with unresectable hepatocellular
carcinoma: HIMALAYA. Presented at ASCO Gastrointestinal Cancers
Symposium 2022.
5. Tarao K, et
al. Real impact of liver
cirrhosis on the development of hepatocellular carcinoma in various
liver diseasesÑmeta‐analytic
assessment. Cancer
Med. 2019;8(3):1054-1065.
6. Colagrande S, et
al. Challenges of advanced
hepatocellular carcinoma. World J
Gastroenterol. 2016;22(34):7645-7659.
7. WHO. World Cancer Fact Sheet.
Available at:
https://gco.iarc.fr/today/data/factsheets/cancers/39-All-cancers-fact-sheet.pdf.
Accessed March 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:
25 April 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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