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
2020
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
reports under cover of Form 20-F or Form 40-F.
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as permitted by Regulation S-T Rule 101(b)(7): ______
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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.
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assigned to the Registrant in connection with Rule 12g3-2(b):
82-_____________
AstraZeneca PLC
INDEX
TO EXHIBITS
1.
Imfinzi,
tremelimumab granted ODD in liver cancer
20 January 2020 07:00 GMT
Imfinzi and
tremelimumab granted Orphan
Drug Designation in the US for liver cancer
AstraZeneca's Imfinzi (durvalumab) and tremelimumab, an
anti-CTLA4 antibody and potential new medicine, have both been
granted Orphan Drug Designation (ODD) in the US for the treatment
of hepatocellular carcinoma (HCC), the most common type of liver
cancer.
The US Food and Drug Administration (FDA) grants ODD to medicines
intended for the treatment, diagnosis or prevention of rare
diseases or disorders that affect fewer than 200,000 people in the
US.
Liver cancer is the third leading cause of cancer death worldwide
and for patients with unresectable or advanced disease, only 13%
are alive five years after diagnosis.1-3
José Baselga, Executive Vice President, Oncology R&D,
said: "Many patients with liver cancer are diagnosed and treated
only after the disease is advanced, and there is an urgent need for
new effective and tolerable treatments. We are eager to bring new
potential options to these patients and look forward to the results
of our ongoing Phase III HIMALAYA trial later this
year."
The Phase III HIMALAYA trial is testing Imfinzi and the combination
of Imfinzi plus tremelimumab in patients with
unresectable, advanced HCC who have not been treated with prior
systemic therapy and are not eligible for locoregional
therapy (treatment localised to the liver). HIMALAYA is the
first trial to test dual immune checkpoint blockade in the 1st-line
advanced HCC setting.
Imfinzi is not currently
approved to treat HCC in any country, alone or in combination with
tremelimumab.
Hepatocellular carcinoma (HCC)
Liver cancer is the third leading cause of cancer death and the
sixth most commonly diagnosed cancer worldwide.1 HCC
represents about 80% of all primary liver
cancers.4 Approximately
700,000 people were diagnosed with HCC around the world in 2018,
and an estimated 42,000 people were diagnosed in the US last
year.1,2 Between
80-90% of all patients with HCC also have chronic liver disease,
which is primarily caused by infection with the hepatitis B or C
viruses.5,6 Chronic
liver disease is associated with inflammation that, over time,
results in immunosuppression and can lead to the development of
HCC.7,8 The
unique immune environment of liver cancer provides clear rationale
for researching medicines that harness the power of the immune
system to treat HCC.9 A
critical unmet need exists for patients with HCC who face limited
treatment options.10 More
than half of patients are diagnosed at advanced stages of the
disease, often when symptoms first appear.11,12
HIMALAYA
HIMALAYA is a randomised, open-label, multicentre, global Phase III
trial of Imfinzi monotherapy and the combination
of Imfinzi and tremelimumab vs. the standard-of-care
medicine sorafenib, a multi-kinase inhibitor, in patients with
unresectable, advanced HCC who have not been treated with prior
systemic therapy and are not eligible for locoregional therapy. The
trial is being conducted in 189 centres across 16 countries
including in the US, Canada, Europe, South America and Asia. The
primary endpoint is overall survival and key secondary endpoints
include objective response rate and progression-free
survival.
Imfinzi
Imfinzi (durvalumab) is a
human monoclonal antibody that binds to PD-L1 and blocks the
interaction of PD-L1 with PD-1 and CD80, countering the tumour's
immune-evading tactics and releasing the inhibition of immune
responses.
Imfinzi is approved in the
curative-intent setting of unresectable, Stage III non-small cell
lung cancer (NSCLC) after chemoradiation therapy in 54 countries,
including the US, Japan, China and across the EU, based on the
Phase III PACIFIC trial. Imfinzi is
also approved for previously treated patients with advanced bladder
cancer in 11 countries, including the US.
Imfinzi is under Priority
Review with FDA for the treatment of patients with previously
untreated extensive-stage small cell lung cancer (SCLC) in
combination with chemotherapy. A Prescription Drug User
Fee Act date is set for the first quarter of
2020.
As part of a broad development programme, Imfinzi is also being tested as a monotherapy and in
combination with tremelimumab, an anti-CTLA4 monoclonal antibody
and potential new medicine, as a treatment for patients with NSCLC,
SCLC, bladder cancer, head and neck cancer, liver cancer, biliary
tract cancer, cervical 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.
Tremelimumab is being tested in a clinical trial programme in
combination with Imfinzi in NSCLC, SCLC, bladder cancer, head and
neck cancer and liver cancer.
AstraZeneca's approach to Immuno-Oncology (IO)
Immuno-oncology (IO) is a therapeutic approach designed to
stimulate the body's immune system to attack tumours. The Company's
IO portfolio is anchored by immunotherapies that have been designed
to overcome anti-tumour immune suppression. AstraZeneca believes
that IO-based therapies offer the potential for life-changing
cancer treatments for the clear majority of patients.
The Company is pursuing a comprehensive clinical-trial programme
that includes Imfinzi as a monotherapy and in combination with
tremelimumab in multiple tumour types, stages of disease, and lines
of therapy, 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, small targeted 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 has a deep-rooted heritage in oncology and offers a
quickly growing portfolio of new medicines that has the potential
to transform patients' lives and the Company's future. With at
least six new medicines to be launched between 2014 and 2020, and a
broad pipeline of small molecules and biologics in development, the
Company is committed to advance oncology as a key growth driver for
AstraZeneca focused on lung, ovarian, breast and blood cancers. In
addition to AstraZeneca's main capabilities, the Company is
actively pursuing innovative partnerships and investments that
accelerate the delivery of our strategy, as illustrated by the
investment in Acerta Pharma in haematology.
By harnessing the power of four scientific platforms -
Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage Response
and Antibody Drug Conjugates - and by championing the development
of personalised combinations, AstraZeneca has the vision to
redefine cancer treatment and one day eliminate cancer as a cause
of death.
AstraZeneca
AstraZeneca (LSE/STO/NYSE: AZN) is a global, science-led
biopharmaceutical company that focuses on the discovery,
development and commercialisation of prescription medicines,
primarily for the treatment of diseases in three therapy areas -
Oncology, Cardiovascular, Renal and Metabolism, and Respiratory.
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.
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Media
Relations
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Gonzalo
Viña
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+44 203
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Rob
Skelding
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Oncology
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+44 203
749 5821
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Rebecca
Einhorn
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Oncology
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+1 301
518 4122
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Kent
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BioPharmaceuticals
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+44 203
749 5906
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Fiorin
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Environmental, Social and Governance
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References
1. World Health
Organization. IARC Globocan 2018 World Fact Sheet. Available
at http://gco.iarc.fr/today/data/factsheets/populations/900-world-fact-sheets.pdf.
Accessed January 2020.
2. National Cancer
Institute. Cancer Stat Facts: Liver and Intrahepatic Bile Duct
Cancer. Available at: https://seer.cancer.gov/statfacts/html/livibd.html.
Accessed January 2020.
3. Vogel A, et al. Hepatocellular carcinoma: ESMO Clinical
Practice Guidelines for diagnosis, treatment and
follow-up. Annals of
Oncology 29 (Supplement
4): iv238-iv255, 2018.
doi:10.1093/annonc/mdy308.
4. ASCO Cancer.net.
ASCO Answers Liver Cancer. Available at https://www.cancer.net/sites/cancer.net/files/asco_answers_liver.pdf.
Accessed January 2020.
5. Dos Santos
P, et
al. Incidence of hepatocellular
carcinoma in patients with chronic liver disease due to hepatitis B
or C and coinfected with the human immunodeficiency virus: a
retrospective cohort study. World J
Gastroenterol. 2018
February 7; 24(5): 613-622. DOI:
10.3748/wjg.v24.i5.613.
6. Hiotis SP, et al. Hepatitis B vs. hepatitis C infection on
viral hepatitis-associated hepatocellular carcinoma. BMC
Gastroenterol 12, 64 (2012)
doi:10.1186/1471-230X-12-64
7. Del Campo
JA., et al. Role of inflammatory response in liver
diseases: Therapeutic strategies. World journal of
hepatology.
2018; 10(1), 1-7.
doi:10.4254/wjh.v10.i1.1
8. Makarova-Rusher
OV, et
al. The yin and yang of evasion
and immune activation in HCC. J Hepatol. 2015; 62 (6): 1420-1429.
9. Han Y, et al. Human
CD141CTLA-41Regulatory Dendritic Cells Suppress T-Cell Response by
Cytotoxic T-LymphocyteAntigen-4-Dependent IL-10 and
Indoleamine-2,3-Dioxygenase Production in Hepatocellular
Carcinoma. Hepatology. 2014 Feb; 59 (2): 567-79.
10. Bupathi M, et al. Hepatocellular carcinoma: Where there is unmet
need. Molecular
oncology. 2015;9(8):1501-1509.
doi:10.1016/j.molonc.2015.06.005.
11. Colagrande S, et al. Challenges of advanced hepatocellular
carcinoma. World J
Gastroenterol. 2016;22(34):7645-7659
doi:10.3748/wjg.v22.i34.7645.
12.
NORD. Hepatocellular Carcinoma (HCC). Available at:
https://rarediseases.org/physician-guide/hepatocellular-carcinoma-hcc/.
Accessed January 2020.
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:
20 January
2020
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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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