Merck KGaA, Pfizer End Phase III Trial in Previously Untreated Advanced Ovarian Cancer

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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