ONO and BMS Report Submission of sBLA for Opdivo (nivolumab) + Yervoy (ipilimumab) as 1L Treatment of Unresectable Advanced or Recurrent ESCC in Japan

September 14, 2021 Auto Bot Biotech, BMS, ipilimumab, Japan, Nivolumab, Opdivo, sBLA, Yervoy 0

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)

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