Opdivo did not improve overall survival in ONO-4538-23 study for recurrent ovarian cancer.- Ono + BMS

Ono Pharmaceutical Co., Ltd. announced that Opdivo (nivolumab) Intravenous Infusion a human anti-human programmed cell death-1 (PD-1) monoclonal antibody, did not demonstrate a significant improvement in overall survival (OS), a primary endpoint, versus chemotherapy in patients with platinum-refractory advanced or recurrent ovarian cancer in the final analysis of a multi-center, randomized, open-label Phase III clinical study (ONO-4538-23) conducted in Japan. About ONO-4538-23 study- This study is a multi-center, randomized, open-label Phase III clinical study (ONO-4538-23) to evaluate the efficacy on OS as the primary endpoint and safety of Opdivo versus chemotherapy (liposomal doxorubicin or gemcitabine) in patients with platinum-refractory advanced or recurrent ovarian cancer. In this study, Opdivo or chemotherapy was administered until disease progression, or onset of severe adverse events is observed. The primary endpoint, OS was assessed for the superiority of Opdivo versus chemotherapy. Comment: There is still hope for Opdivo in ovarian cancer, due to the Phase III ATHENA study in combination with Clovis Oncology Inc.’s PARP inhibitor Rubraca (rucaparib) which is ongoing. This is investigating the combination as a front-line maintenance treatment following platinum-based chemotherapy, in around 1,000 patients with previously untreated advanced ovarian cancer as part of a July 2017 alliance between Clovis and Bristol-Myers Squibb.