BMS received positive EU CHMP opinion for Nivo as an Adj treatment for Melanoma

CAR-T Digest - August 2020

21 Jul 2023: Opdivo (Nivolumab) / Completely Resected Stage IIB or IIC Melanoma / BMS: Received positive EU CHMP opinion

The recommendation was based on results from the Phase 3 CheckMate -76K trial in patients with stage IIB or IIC melanoma, in which Opdivo demonstrated a statistically significant and clinically meaningful benefit in recurrence-free survival versus placebo
Results from the Phase 3 CheckMate -76K trial presented as late-breaking data at the 2022 Society for Melanoma Research (SMR) Annual Meeting
- Efficacy:
  - With a minimum follow-up of 7.8 months, Opdivo reduced the risk of recurrence or death by 58% vs Placebo
  - 12 months RFS: 89% vs 79 %
  - Opdivo: 93% in stage IIB (versus 84% in placebo) and 84% in stage IIC
- Safety:
  - Grade ¾ TRAEs: 10% (Opdivo arm); 2% (Placebo arm)
  - Grade ¾ TRAEs: 10% (Opdivo arm); 2% (Placebo arm)
If approved, this would build upon the 2018 EC approval based on data from the CheckMate -238 trial of Opdivo for the adjuvant treatment of adult patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection