22 November 2016
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.
NOTES TO EDITORS
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.