AstraZeneca pauses two
cancer drug trials' enrolment due to bleeding
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[October 28, 2016]
By Ben Hirschler
LONDON (Reuters) - AstraZeneca's high hopes
for cancer immunotherapy were dented on Thursday as the recruitment of
new patients with head and neck cancer into two clinical studies was put
on hold, following instances of bleeding.
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The drugmaker said the U.S. Food and Drug Administration (FDA) had
placed a partial hold on enrolment into the final-stage Phase III
trials involving two of its immune system-boosting drugs, although
the studies are still continuing with existing patients.
Trials of durvalumab and tremelimumab in different cancer types are
also progressing as planned. Durvalumab is being tested on its own
and with tremelimumab in various cancers.
Expectations for the combination treatment have been building in
particular in lung cancer, where the two-drug cocktail is being
tested in a broad range of patients as an alternative to initial
chemotherapy.
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News of the problems in head and neck cancer first surfaced on the
website clinicaltrials.gov, run by the U.S. National Institutes of
Health, which said one of the trials, known as KESTREL, had been
"suspended".
"The trial is not suspended," an AstraZeneca spokeswoman said. "We
have a pause or a partial clinical hold on enrolment of new
patients."
Shares in AstraZeneca fell more than 4 percent in U.S. trading on
concerns that the setback might signal wider problems for durvalumab.
AstraZeneca sought to play down concerns, however, stressing that
pivotal data in lung cancer were still expected in the first half of
2017.
It also said that bleeding was a known complication in treating head
and neck cancer, given the proximity of tumors to major blood
vessels and use of prior cancer therapies, which may involve surgery
and radiation.
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Merck's rival immunotherapy drug Keytruda is already approved for
head and neck squamous cell carcinoma, the same condition that
AstraZeneca is testing for.
Bernstein analyst Tim Anderson said there was some reference in the
medical literature to a decrease in blood platelets, which are
needed for clotting, when patients were given so-called CTLA4 drugs
like tremelimumab, although cases were rare.
Both Anderson and Deutsche Bank's Richard Parkes said it was unclear
if bleeding constituted a real drug side effect or not.
AstraZeneca said it had submitted its analysis of bleeding events to
the FDA for review and would work to provide the required
information to resume new patient enrolment as soon as possible.
(Editing by Martinne Geller)
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