Merck KGaA, Pfizer End Phase III Trial in Previously Untreated Advanced Ovarian Cancer
March 20 2019 - 11:53AM
Dow Jones News
By Michael Dabaie
Merck KGaA, Darmstadt, Germany (MRK.XE), and Pfizer Inc. (PFE)
said Wednesday they discontinued the Phase III JAVELIN Ovarian PARP
100 study.
The study was evaluating avelumab in combination with
chemotherapy followed by maintenance therapy of avelumab in
combination with talazoparib for previously untreated advanced
ovarian cancer. The companies said they notified health authorities
and trial investigators of the decision to discontinue the
trial.
The decision was based on several emerging factors since the
trial's initiation, including the previously announced interim
results from JAVELIN Ovarian 100. The alliance determined that the
degree of benefit observed with avelumab in frontline ovarian
cancer in that study doesn't support continuation of the trial in
an unselected patient population. Other factors include the rapidly
changing treatment landscape and the approval of a PARP inhibitor
in the frontline maintenance setting. The decision to discontinue
the JAVELIN Ovarian PARP 100 trial wasn't made for safety reasons,
the companies said.
The decision to discontinue the JAVELIN Ovarian PARP 100 trial
doesn't impact the currently approved indications for avelumab or
the remainder of the ongoing JAVELIN clinical development
program.
Merck KGaA operates its biopharmaceutical business as EMD Serono
in the U.S. and Canada.
Write to Michael Dabaie at michael.dabaie@wsj.com
(END) Dow Jones Newswires
March 20, 2019 12:38 ET (16:38 GMT)
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