AstraZeneca, the Anglo-Swedish pharmaceutical group, has said that it is restarting clinical trials of durvalumab, one of its most-watched new cancer treatments, after US regulators lifted a partial freeze on enrolling new patients that was imposed last month.
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Despite the relatively small scale of the trial suspension, investors were shaken because the immunotherapy is seen as one of AstraZeneca’s greatest hopes for returning to growth after pressure on sales since 2011.
News of the US Food and Drug Administration’s partial halt to the enrolment of new patients with head and neck cancer sent the drugmaker’s share price to its lowest in two years.
AstraZeneca on Tuesday said that its Phase III Kestrel trial had already reopened for new patients at some sites, while the Eagle trial was expected to resume recruitment shortly. The company also said that the bleeding that prompted the FDA’s initial ban was a known complication in head and neck cancer treatments because of the nature of the underlying disease.
The FDA lifted the partial hold after “a review of the comprehensive analysis provided by AstraZeneca of bleeding events that were observed as part of the routine safety monitoring”, the company said.
AstraZeneca has pinned hopes on durvalumab as a potential breakthrough treatment for several forms of cancer. The drug is designed to use a patient’s own defence system to attack tumours, overwhelming their immune-evading systems, and is being studied as a potential treatment for various forms of the disease, including bladder, gastric, pancreatic and blood cancers.
The company is one of several drugmakers eyeing the promising field of immunotherapy treatments for cancer, as opposed to conventional chemotherapy.
Bristol-Myers Squibb has seen quick returns from its drug Opdivo, which treats lung cancer, and recorded $920m in revenue during the third quarter of 2016. Merck & Coalso recently secured approval for its immunotherapy cancer drug Keytruda as a first-line treatment for certain lung cancer patients.
Steve McGarry, HSBC analyst, welcomed the removal of the restrictions on the AstraZeneca trials, but, in a note to clients, said that the bleeding may “not be just related to the head and neck cancer”. If that proves to be the case, the side effect “could have negative commercial implications in due course”.
The “bleeding side effect has not been seen with competitor drugs”, wrote Mr McGarry in a note to clients.
AstraZeneca posted a drop in profits and weaker than expected sales in the third quarter despite advances in bringing new products to market, as competition from generic rivals dragged down revenues of its best-selling cholesterol medication Crestor.