BMS’s OPDIVO + Chemo approved in the EU for Neoadjuvant NSCLC (PD-L1 ≥1%)

CAR-T Digest - August 2020

29 Jun 2023: OPDIVO (Nivolumab) / Neoadjuvant NSCLC / BMS: OPDIVO + Chemo approved in the EU

The approval was based on the Phase 3 CheckMate -816 study showing that neoadjuvant Nivolumab + chemotherapy improved event-free survival and pathologic complete response vs chemotherapy alone
- Phase 3 CheckMate -816 study of Nivolumab + Ipilimumab or Nivolumab + platinum doublet chemotherapy vs platinum doublet chemotherapy in early-stage NSCLC (n = 505
Results:
- Efficacy: (Nivolumab + chemo vs chemo)
  - EFS: 31.6 months vs 20.8 months (HR: 0.63; p=0.0052)
  - pCR: 24% vs 2.2% (HR: 13.9; p<0.0001)
  - OS: The combination reduced the risk of death by 43% (HR: 0.57)
- Safety: n=1268
  - Most frequent AEs (≥ 10%): Nausea (51%), peripheral neuropathy (39%), fatigue (39%), diarrhea (33%), decreased appetite (33%), constipation (31%), vomiting (27%), stomatitis (22%), abdominal pain (21%), rash (18%), pyrexia (17%), musculoskeletal pain (16%), cough (13%), oedema (including peripheral oedema) (12%) and hypoalbuminemia (11%)
OPDIVO with chemotherapy is now the first and only neoadjuvant immunotherapy-based treatment option approved to treat patients with NSCLC in the EU
- The combo was first granted approval by the US FDA in Apr 2022
- The rival Merck’s Pembrolizumab is expected to get approved in Q4 2023 (PDUFA: Oct 16, 2023) by the US FDA