* Head and neck cancer studies resume patient recruitment
* Trials involve AstraZeneca's immunotherapy durvalumab
(Adds shares, further details on immunotherapy)
By Ben Hirschler
LONDON, Nov 22 U.S. officials have given a green
light for two clinical trials testing AstraZeneca's
immunotherapy drug durvalumab in head and neck cancer to resume
recruiting patients, lifting a hold imposed following cases of
One of the late-stage Phase III trials had already re-opened
for new patient enrolment and the second was expected to resume
recruitment shortly, the British drugmaker said on Tuesday
News of the partial hold on the trials, imposed at the end
of last month, had spooked investors since durvalumab is
AstraZeneca's most important pipeline medicine.
Shares in AstraZeneca gained around 1 percent on Tuesday as
the company announced the lifting of the partial clinical trial
hold by the U.S. Food and Drug Administration.
Durvalumab is being tested on its own and with another
immune system-boosting drug called tremelimumab in various
cancers, including lung cancer, which represents the biggest
Although trials of the drug in these other tumour types were
not affected by the head and neck issue, there had been concerns
there might be a problem with durvalumab or tremelimumab that
could disrupt wider development.
Data due in lung cancer in the first half of 2017 will be
critical in determining AstraZeneca's position in the cancer
arena, where it faces immunotherapy rivals including Merck
, Bristol-Myers Squibb and Roche.
Bleeding is a known complication in treating head and neck
cancer, given the proximity of tumours to major blood vessels
and use of prior cancer therapies, which may involve surgery and
AstraZeneca had initially hoped that it might win early
approval of durvalumab in head and neck cancer but it said on
Nov. 10 it had given up the idea due to changes in the
This follows the approval of Merck's similar drug Keytruda
for the condition, which reduced the case for special regulatory
treatment of durvalumab.
(Reporting by Ben Hirschler; Editing by Mark Potter/Keith Weir)