AstraZeneca’s head and neck cancer treatment clinical trials put on hold
pharmafile | October 31, 2016 | News story | Sales and Marketing | AstraZeneca, clinical hold, clinical trials, immunotherapy, phase III
AstraZeneca, the Cambridge-based British company, had recruitment for its final stage Phase III trials placed on partial hold. The drug in question is durvalumab, which is being tested for treatment of Head and Neck cancer. The FDA has put a partial clinical hold on the recruitment of new patients to their two clinical trials due to bleeding.
The news comes as a blow to AstraZeneca, causing investors to worry that the issues may be indicative of wider issues for the drug. AstraZeneca’s shares fell more than 4% on the release of the news.
AstraZeneca released a statement on the release of the news: “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.”
The company has remained bullish about their estimations for the drug, citing the fact that results of the trial will not be released until the first half of 2017. The company has submitted its analysis of the bleeding in patients to the FDA for review, with the aim of having recruitment reopen for the trials as soon as possible. At present, the trials can continue but without additional patients.
AstraZeneca’s immunotherapy is playing catch up with the current leader in the market, BMS’ Opdivo, whilst rivals MSD and Roche have forged ahead with their own treatments, Keytruda and Tecentriq respectively.
Ben Hargreaves
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