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 2020
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
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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.
Update
on Phase III DANUBE trial for Imfinzi and
tremelimumab in unresectable, Stage IV bladder
cancer
6 March 2020 07:00 GMT
Update on Phase III DANUBE trial
for Imfinzi and
tremelimumab in unresectable, Stage IV bladder cancer
The Phase III DANUBE trial for Imfinzi (durvalumab) and Imfinzi plus tremelimumab in unresectable, Stage IV
(metastatic) bladder cancer did not meet the primary endpoints of
improving overall survival (OS) versus standard-of-care (SoC)
chemotherapy for Imfinzi monotherapy in patients whose tumour cells
and/or tumour-infiltrating immune cells express high levels
(≥25%) of PD-L1, or for Imfinzi plus tremelimumab in patients regardless of
their PD-L1 expression.
José Baselga, Executive Vice President, Oncology R&D,
said: "AstraZeneca remains committed to addressing unmet needs in
bladder cancer and the potential for immunotherapy to improve
outcomes for these patients. The results from this trial will
inform our comprehensive Phase III development programme in bladder
cancer. We look forward to the results of the Phase III NILE trial
also in the 1st-line metastatic setting, and we continue to advance
clinical trials for patients at earlier stages of the
disease."
The safety and tolerability profiles for Imfinzi and the combination with tremelimumab were
consistent with previous trials. The data will be presented at a
forthcoming medical meeting.
Imfinzi is
being developed in patients with unresectable, locally
advanced or metastatic bladder cancer in the Phase III NILE trial
either in combination with chemotherapy or with chemotherapy and
tremelimumab. Imfinzi is also being tested in earlier stages of
bladder cancer in the Phase III NIAGARA trial in combination with
chemotherapy, and in the Phase III POTOMAC trial in combination
with SoC Bacillus Calmette-Guerin
immunotherapy.
Imfinzi is approved for
patients with locally advanced or metastatic bladder cancer
previously treated with platinum-containing chemotherapy in 15
countries, including the US.
Bladder cancer
In 2018, approximately 550,000 people were diagnosed with
bladder cancer around the world and 200,000 died from the
disease.1 Locally
advanced and metastatic bladder cancer remains an area of unmet
medical need and typically only one in seven patients are alive
five years after diagnosis.2 Urothelial
cancer (UC) is the most common form of bladder
cancer.3 UC
is the 10th most common cancer worldwide and the 13th
most common cause of cancer death.1,4 PD-L1
is widely expressed in tumour and immune cells in patients with
bladder cancer and helps tumours evade detection from the immune
system.5
DANUBE
DANUBE is a randomised, open-label, multi-centre, global, Phase III
trial in the 1st-line treatment of both cisplatin eligible and
ineligible patients with unresectable, Stage IV (metastatic) UC.
The trial compared Imfinzi monotherapy or Imfinzi plus tremelimumab versus cisplatin and
gemcitabine or carboplatin and gemcitabine chemotherapy. The trial
was conducted in more than 220 centres across 24 countries,
including centres in the US, Canada, Europe, South America, Asia,
Australia and the Middle East.
Eligible patients included those with transitional cell carcinoma
of the urothelium, including renal pelvis, ureters, urinary
bladder, and urethra. High PD-L1 was defined as ≥25% of
tumour cells (TC) or tumour-infiltrating immune cells (IC)
expressing membrane PD-L1 if ICs involved >1% of the tumour
area, or TC≥25% or IC=100% if ICs involved ≤1% of the
tumour area.
The primary endpoints of the trial were OS in high PD-L1 patients
treated with Imfinzi monotherapy, and OS in patients treated
with Imfinzi plus tremelimumab regardless of their PD-L1
status. The DANUBE trial addresses a post-approval commitment in
agreement with the US Food and Drug Administration from the May
2017 accelerated US approval of Imfinzi in previously treated patients with advanced
bladder cancer.
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 61 countries,
including the US, Japan, China and across the EU, based on the
Phase III PACIFIC trial. Imfinzi recently received its first global approval
for the 1st-line treatment of extensive-stage small cell lung
cancer (ES-SCLC) in combination with SoC chemotherapy in
Singapore.
As part of a broad development programme, Imfinzi is also being tested as a monotherapy and in
combinations including 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, 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, 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 six new
medicines 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.
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.
Media Relations
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Viña
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+44 203 749 5916
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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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Fiorin
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Hursit
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Thomas
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+44 203 749 5712
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Henry
Wheeler
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+44 203 749 5797
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Gruvris
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+44 203 749 5711
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References
1. World Health
Organization International Agency for Research on Cancer. Cancer
Fact Sheets - Bladder. Available at http://gco.iarc.fr/today/data/factsheets/cancers/30-Bladder-fact-sheet.pdf Accessed
February 2020.
2. Von der Maase
H, et
al. Long-Term Survival
Results of a Randomized Trial Comparing Gemcitabine Plus Cisplatin,
With Methotrexate, Vinblastine, Doxorubicin, Plus Cisplatin in
Patients With Bladder Cancer. J Clin
Oncol. 2005;23:4602-4608.
3. American Society
of Clinical Oncology. Bladder Cancer: Introduction. Available
at https://www.cancer.net/cancer-types/bladder-cancer/introduction.
Accessed February 2020.
4. World Cancer
Research Fund. Bladder cancer statistics. Available
at https://www.wcrf.org/dietandcancer/cancer-trends/bladder-cancer-statistics.
Accessed February 2020.
5. Magdalene
J, et
al. Joseph
M, et
al. Immune Responses in
Bladder Cancer-Role of Immune Cell Populations, Prognostic Factors
and Therapeutic Implications. Front Oncol.2019;9:1270.
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:
06 March
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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