BMS’ Opdivo (nivolumab) + Yervoy (ipilimumab) Receives the US FDA Approval as 1L Treatment for Unresectable Advanced or Metastatic Esophageal Squamous Cell Carcinoma

Shots:

The approvals were based on the P-III (CheckMate -648) trial evaluating Opdivo + Yervoy or Opdivo + CT vs CT alone in adult patients with prior untreated unresectable advanced, recurrent, or metastatic ESCC
The results showed that Opdivo + Yervoy or Opdivo + CT improved OS in all randomized & tumors express PD-L1 (≥1%) patients. In both patients with Opdivo + CT, m-OS (13.2mos. & 15.4mos. vs 10.7mos. & 9.1mos.); m-PFS (5.8mos. & 6.9mos. vs 5.6mos. & 4.4mos.)
Opdivo + Yervoy showed m-OS (12.8mos. & 13.7mos. vs 10.7mos. & 9.1 mos.) in both patients; m-PFS (4.0mos. vs 4.4mos.) in tumors express PD-L1 (≥1%) patients, patients discontinued treatment in Opdivo + Yervoy or Opdivo + CT (23% & 39%)

Ref: BMS  | Image: BMS