Germany-based Merck KGaA and United States-based Pfizer have withdrawn the Phase III JAVELIN Ovarian PARP 100 study assessing the efficacy and safety of avelumab in combination with chemotherapy followed by maintenance therapy of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.
TiumBio files Clinical Trial Application to start Phase 1b TU7710 study
Moderna reports positive interim results from next-generation COVID-19 vaccine trial
Scancell initiates SCOPE trial's iSCIB1+ cohort
Valneva launches Phase 1 trial for next-generation Zika vaccine
argenx obtains VYVGART approval for primary immune thrombocytopenia in Japan
Bio-Thera Solutions' BAT8006 phase II Study receives US FDA IND approval