NEW YORK CITY (dpa-AFX) - Merck KGaA, and Pfizer Inc. (PFE), on Friday, announced that data from a planned interim analysis of the Phase III JAVELIN Ovarian 100 study of avelumab did not support the study's initial hypothesis. The alliance has decided to terminate the trial in alignment with the independent Data Monitoring Committee. The JAVELIN Ovarian PARP 100 study and earlier phase studies investigating avelumab in various combinations are ongoing.
The topline results showed that the study, which is evaluating avelumab in combination with and/or following platinum-based chemotherapy in previously untreated patients with ovarian cancer, would not achieve superiority in the pre-specified primary endpoint of progression-free survival. The safety profile for avelumab in the trial was consistent with that observed in the overall JAVELIN clinical development program.
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