Shots:

• The applications are based on P-III CheckMate -648 trial evaluates Opdivo (3 mg/kg- q2w) + Yervoy (1 mg/kg- q6w up to 24mos.) or Opdivo (nivolumab) + CT vs CT alone in patients with unresectable advanced or metastatic ESCC
• Results: Both combinations showed OS benefit over CT at the pre-specified interim analysis in patients with tumor cell PD-L1 expression ≥1% & all-randomized population while safety profiles were consistent with the known safety profiles of the individual components
• The MAA validation confirms that the submissions are complete- and the EMA will now initiate the review procedure. The results were presented at ASCO 2021

 Ref: Businesswire | Image: BMS