Policy & Regulation
Merck KGaA and Pfizer discontinue ovarian cancer drug trial
21 March 2019 -

Germany-based Merck KGaA and United States-based Pfizer have withdrawn the Phase III JAVELIN Ovarian PARP 100 study assessing the efficacy and safety of avelumab in combination with chemotherapy followed by maintenance therapy of avelumab in combination with talazoparib, a poly (ADP-ribose) polymerase (PARP) inhibitor, versus an active comparator in treatment-naïve patients with locally advanced or metastatic ovarian cancer (stage III or stage IV), it was reported yesterday.

Both firms have notified health authorities and trial investigators of the decision to withdraw the trial.

The decision has been taken based on various emerging factors since the trial's initiation, including the earlier 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 does not support continuation of the JAVELIN Ovarian PARP 100 trial in an unselected patient population, and emphasises the need to better understand the role of immunotherapy in ovarian cancer. The decision to discontinue the JAVELIN Ovarian PARP 100 trial was not made for safety reasons.

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