Cstone — Cejemly EMA EPAR variation assessment report (EMEA/H/C/006088, 2024)
Cstone · 2024 · EMA EPAR variation assessment report
Report summary
This report details a Type II variation application for Cejemly (sugemalimab) to extend its indication to unresectable stage III non-small-cell lung cancer (NSCLC) as consolidation therapy. The application is based on final results from the Phase III study CS1001-301 (GEMSTONE-301), a double-blinded trial conducted in China. Sugemalimab, a PD-L1 inhibitor, demonstrated a statistically significant improvement in progression-free survival (PFS) compared to placebo, with a median PFS of 10.5-10.6 months versus 6.2 months. While overall survival (OS) did not reach statistical significance at the interim analysis, the safety profile was consistent with other PD-L1 agents, with immune-related adverse reactions being the main concern. The indication is restricted to patients with PD-L1 expression >=1% due to limited data. The report also includes pharmacokinetic data supporting a weight-based dosing regimen.
Key findings — cited to the page
| Grade 4 placebo-related TEAEs | 1.6 % | CS1001-301 · p.68 |
| Grade 4 sugemalimab-related TEAEs | 1.2 % | CS1001-301 · p.68 |
| Grade 5 (fatal) sugemalimab-related TEAEs | 1.2 % | CS1001-301 · p.68 |
| Immune-related AEs (Grade 3-4) | 7.8 % | CS1001-301 · p.93 |
| AEs Grade 5 | 4.7 % | CS1001-301 · p.93 |
| AEs Grade 5 (control) | 2.4 % | CS1001-301 · p.93 |
| Grade > 3 TEAEs | 34.1 % | study 301 · p.92 |
| AEs Grade 3-4 | 29.4 % | CS1001-301 · p.93 |
| AEs Grade 3-4 (control) | 27.8 % | CS1001-301 · p.93 |
| Grade > 3 TEAEs | 30.2 % | study 301 · p.92 |
| immune-mediated lung disease (Grade > 3) | 3.1 % | · p.92 |
| Immune-related AEs (Grade 3-4, control) | 0 % | CS1001-301 · p.93 |
Source: Cstone ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Oncology library →