other material
confidence high
sentiment positive
materiality 0.90
Novocure LUNAR phase 3 trial meets primary endpoint; median OS improved 3 months in NSCLC
NovoCure Ltd
- LUNAR trial met primary endpoint: median OS 13.2 mo (TTFields+SOC) vs 9.9 mo (SOC alone); HR 0.74, p=0.035.
- ICI subgroup showed median OS 18.5 mo (TTFields+ICI) vs 10.8 mo (ICI alone); HR 0.63, p=0.03.
- TTFields therapy well-tolerated with no added systemic toxicities; few grade 3 device-related AEs.
- One-year survival 53% vs 42% (p=0.04); three-year survival 18% vs 7% (p=0.015).
- Novocure plans PMA submission to FDA in H2 2023 based on LUNAR data.