Blueprint
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 October 2016
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
Indicate by check
mark whether the registrant files or will file annual reports under
cover of Form 20-F or Form 40-F.
Form
20-F X Form 40-F __
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mark if the registrant is submitting the Form 6-K in paper as
permitted by Regulation S-T Rule 101(b)(1):
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mark if the registrant is submitting the Form 6-K in paper as
permitted by Regulation S-T Rule 101(b)(7): ______
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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.
Yes __
No X
If
“Yes” is marked, indicate below the file number
assigned to the Registrant in connection with Rule 12g3-2(b):
82-_____________
AstraZeneca PLC
INDEX
TO EXHIBITS
1
AstraZeneca Head and Neck Cancer Trials dated 27th October 2016
27 October 2016 16:50
ASTRAZENECA HEAD AND NECK CANCER TRIALS
Following
the recent update on clinicaltrials.gov, AstraZeneca confirms that
the US FDA has placed a partial clinical hold on the enrolment of
new patients with head and neck squamous cell carcinoma (HNSCC) in
clinical trials of durvalumab as monotherapy and in combination
with tremelimumab or other potential medicines. All trials are
continuing with existing patients.
The
partial clinical hold on new patient enrolment relates only to head
and neck cancer. Trials for durvalumab in different cancer types,
as monotherapy or in combination with tremelimumab or other
potential medicines, are progressing as planned, with pivotal data
in lung cancer anticipated in the first half of 2017.
The FDA's decision follows voluntary action by
AstraZeneca to pause enrolment of new HNSCC patients while a
detailed analysis is conducted of adverse events related to
bleeding that were observed as part of routine safety monitoring of
the Phase III KESTREL and EAGLE trials. Bleeding is a known
complication in treatments of head and neck cancers primarily due
to the nature of the underlying disease, the proximity of tumours
to major blood vessels and use of prior cancer therapies, which may
involve surgery and radiation.
AstraZeneca has
submitted its analysis of the observed bleeding events to the FDA
for review and is working closely with the Agency, providing the
required information to resume new patient enrolment as soon as
possible.
About AstraZeneca
AstraZeneca 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 main therapy areas - Oncology, Cardiovascular &
Metabolic Diseases and
Respiratory. The Company also is selectively active in the areas of
autoimmunity, neuroscience and infection. AstraZeneca operates in
over 100 countries and its innovative medicines are used by
millions of patients worldwide. For more information, please
visit www.astrazeneca.com and
follow us on Twitter @AstraZeneca.
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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.
AstraZeneca
PLC
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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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