FDA places partial hold on durvalumab as monotherapy and in combination with tremelimumab in trials for head and neck cancer- AstraZeneca

AstraZeneca confirms that the FDA has placed a partial clinical hold on the enrollment 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 enrollment 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 enrollment 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.