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

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

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

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 

Click here to­ read the full press release 

Tuba

Tuba was Senior Editor at PharmaShots. She was curious, creative, and passionate about recent updates and innovations in the life sciences industry. She covered Biopharma, MedTech, and Digital health segments. Tuba also had an experience in digital and social media marketing and ran the campaigns independently. She can be contacted at connect@pharmashots.com.

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