AstraZeneca Suspends Recruitment in Two Cancer Clinical Trials

AstraZeneca PLC said it had suspended enrollment into two large clinical trials on head and neck cancer while it investigates whether the treatment is causing patients to bleed.

Cambridge, U.K.-based AstraZeneca said it had observed bleeding in some patients as part of routine safety monitoring of the two trials and had paused recruitment to analyze those incidents.

It said bleeding is a known complication in treatments of head and neck cancers "due to the nature of the underlying disease, the proximity of tumors to major blood vessels and use of prior cancer therapies, which may involve surgery and radiation."

The company said it had submitted its analysis of the bleeding events to the U.S. Food and Drug Administration for review and was working closely with the agency to resume new patient enrollment as soon as possible.

The trials in question are testing whether a drug called durvalumab, used alone or in combination with one of Astra's other experimental cancer medicines, prolongs survival in patients with head and neck cancer. Patients already enrolled in the trial will continue to take the drugs, according to a company spokesman.

Astra also is testing these drugs in lung and bladder cancer, but said the suspension related only to head-and-neck-cancer patients.

Durvalumab and other new cancer drugs are key to AstraZeneca hitting the ambitious growth targets it unveiled in 2014 to defend against an unsolicited, and ultimately failed, takeover bid by Pfizer Inc. The company aims to increase revenue to $45 billion by 2023, compared with $25 billion in 2015. AstraZeneca predicts that durvalumab will generate $6.5 billion in annual revenue at its peak, if approved as a treatment for several tumor types.

AstraZeneca shares trading in London closed down 3.4% at £ 46.15. Its American depositary receipts in New York were down 4.4% at $28.28.

Write to Denise Roland at [e-mail]

(END) Dow Jones Newswires

October 27, 2016 13:45 ET (17:45 GMT)

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