27 October 2016 16:50


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

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