More Ovarian Cancer Woes for Merck KGaA and Pfizer as They Halt Late-Stage Trial

Merck KGaA, Darmstadt, Germany, and Pfizer discontinued a Phase III ovarian cancer drug trial after determining that the degree of benefit observed in the treatment during an interim analysis does not support the continuation of the trial. It was the second ovarian cancer trial the two companies collaborated on that failed within the past six months. In the Phase III JAVELIN Ovarian PARP 100 study, the two companies were evaluating the efficacy and safety of Bavencio (avelumab), an anti-PD-L1 antibody, in combination with chemotherapy followed by maintenance therapy of avelumab in combination with talazoparib, Pfizer’s PARP inhibitor it gained from the acquisition of Medivation, versus an active comparator in treatment-naïve patients with locally advanced or metastatic ovarian cancer.The companies said the results emphasize the need to better understand the role of immunotherapy in ovarian cancer. In addition to the benefit issues, Merck KGaA and Pfizer said other factors contributing to the discontinuation of the study include “the rapidly changing treatment landscape and the approval of a PARP inhibitor in the frontline maintenance setting.” The companies stressed that the decision to discontinue the trial was not made for safety reasons.