Shots:

• The application is based on P-III CheckMate -648 study evaluating Opdivo (3mg/kg- q2w- IV) + Yervoy (1mg/kg- q6w up to 24mos.) or Opdivo + CT vs CT alone in patients with unresectable advanced or recurrent ESCC
• The results demonstrated an improvement in OS at pre-specified interim analysis in patients with tumor cell PD-L1 expression ≥1% & all-randomized population with both combination therapy. The safety profiles were consistent with the known safety profiles of the individual components
• ONO also submitted an sBLA of Opdivo + CT for the same indication. In the 2011 agreement- BMS got territorial rights from Ono to develop & commercialize Opdivo globally (Ex-Japan- South Korea & Taiwan)

   Ref: Ono Pharma | Image: BMS