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2016-11-22

AstraZeneca: AstraZeneca head and neck cancer trials resume new patient enrolment as FDA lifts partial clinical hold

AstraZeneca today announced that the US FDA has lifted the partial
clinical hold on the enrolment of new patients with head and neck
squamous cell carcinoma (HNSCC) for clinical trials of durvalumab as
monotherapy and in combination with tremelimumab or other potential
medicines.

The Phase III KESTREL trial has already re-opened for new patient
enrolment at some clinical study sites and the EAGLE trial is
expected to resume recruitment shortly, without amendments to either
protocol. AstraZeneca will progressively resume enrolment for all
HNSCC trials across the participating sites in the US and globally,
subject to national health authority and ethics committee approval
where required. The status of active recruitment will be reflected on
clinicaltrials.gov in the coming days.

The partial clinical hold on new patient enrolment was communicated on
27 October, after preliminary findings from ongoing clinical trials
related specifically to head and neck cancer. The FDA lifted the
partial clinical hold following a review of the comprehensive
analysis provided by AstraZeneca of bleeding events that were
observed as part of the routine safety monitoring of the Phase III
KESTREL and EAGLE trials.

Monitoring of safety signals is an integral part of the development
process for new medicines. 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.

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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http://news.cision.com/se/astrazeneca/r/astrazeneca-head-and-neck-cancer...

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