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 February 2021
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
Voluntary withdrawal of Imfinzi indication in advanced bladder
cancer in the US
22 February 2021 07:00 GMT
Voluntary withdrawal
of Imfinzi indication
in advanced bladder cancer in the US
AstraZeneca today announced the voluntary withdrawal of
the Imfinzi (durvalumab) indication in the US for
previously treated adult patients with locally advanced or
metastatic bladder cancer. This decision was made in consultation
with the Food and Drug Administration (FDA).
In May 2017, Imfinzi was granted accelerated approval in the US
based on promising tumour response rates and duration of response
data from Study 1108, a Phase I/II trial that evaluated the safety
and efficacy of Imfinzi in advanced solid tumours, including
previously treated bladder cancer. Continued approval
was contingent on results from the DANUBE Phase III trial in
the 1st-line metastatic bladder cancer setting, which did not meet
its primary endpoints in 2020. The withdrawal is aligned with FDA
guidance for evaluating indications with accelerated approvals that
did not meet post-marketing requirements, as part of a broader
industry-wide evaluation. This withdrawal does not impact the
indication outside the US and does not impact other
approved Imfinzi indications within or outside the
US.
Dave Fredrickson, Executive Vice President, Oncology Business Unit,
said: "The science of immunotherapy has moved swiftly over the past
few years, bringing new options to patients at an unprecedented
pace. While the withdrawal in previously treated metastatic bladder
cancer is disappointing, we respect the principles FDA set out when
the accelerated approval pathway was founded and remain committed
to bringing new and innovative options to patients. In the last
three years, Imfinzi has become an important standard of care in
multiple lung cancer settings, an area of considerable focus for
AstraZeneca."
Healthcare providers are being notified of this update. Patients
with metastatic bladder cancer currently being treated
with Imfinzi should consult with their healthcare
provider regarding their ongoing care.
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 the US, Japan,
China, across the EU and in many other countries, based on the
PACIFIC Phase III trial. Imfinzi is also approved in the EU, US, Japan 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.
As part of a broad development programme, Imfinzi is 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, liver cancer, biliary tract
cancer, oesophageal cancer, gastric and gastroesophageal cancer,
cervical cancer, ovarian cancer, endometrial cancer, and other
solid tumours.
In bladder cancer, the Company has several Phase III trials
testing Imfinzi in various treatment combinations across
early- and late-stage settings including the NILE Phase III trial
in metastatic disease, the NIAGARA Phase III trial in muscle
invasive disease and the POTOMAC Phase III trial in non-muscle
invasive disease.
AstraZeneca in immunotherapy
Immunotherapy is a therapeutic approach designed to stimulate the
body's immune system to attack tumours. The Company's 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 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 seven 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.
By harnessing the power of six scientific platforms
- Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage
Response, Antibody Drug Conjugates, Epigenetics, and Cell
Therapies - 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/Nasdaq: 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 & 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.
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:
22 February
2021
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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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