Accord S L U — Hetronifly EMA EPAR variation assessment report (EMEA/H/C/006170, 2025)
Accord S L U · 2025 · EMA EPAR variation assessment report
Report summary
This report details a Type II variation application for Accord Healthcare S.L.U.'s Hetronifly (serplulimab), submitted July 30, 2025, to extend its indication for first-line treatment of unresectable, locally advanced or metastatic squamous non-small cell lung carcinoma (NSCLC) in combination with carboplatin and nab-paclitaxel. This is based on final results from the pivotal Phase III study HLX10-004-NSCLC303, which demonstrated significant improvements in progression-free survival and overall survival. While a population pharmacokinetic analysis identified minor covariate influences, no dose adjustments are needed for mild renal/hepatic impairment. Efficacy was lower in non-Asian patients, but the overall benefit-risk balance for serplulimab was deemed positive, despite common treatment-emergent adverse events.
Key findings — cited to the page
| Grade ≥ 3 TESAEs (pooled safety population) | 34.7% | · p.131 |
| Grade ≥ 3 TEAEs (related) (serplulimab arm) | 35.5 % | · p.132 |
| Serplulimab/placebo-related Grade ≥ 3 TEAEs (serplulimab arm) | 35.5% | HLX10-004-NSCLC303 · p.130 |
| Serplulimab-related Grade ≥ 3 TEAEs (pooled safety population) | 34.3% | · p.131 |
| Grade ≥ 3 TEAEs (serplulimab arm) | 85.2 % | · p.132 |
| Grade ≥ 3 TEAEs (control arm) | 79.3 % | · p.132 |
| Grade ≥ 3 TEAEs (serplulimab arm) | 85.2% | HLX10-004-NSCLC303 · p.130 |
| Grade ≥ 3 TEAEs (placebo arm) | 79.3% | HLX10-004-NSCLC303 · p.130 |
| Serplulimab/placebo-related Grade ≥ 3 TEAEs (placebo arm) | 31.8% | HLX10-004-NSCLC303 · p.130 |
| Grade ≥ 3 TEAEs (pooled safety population) | 70.3% | · p.131 |
| Serplulimab-related Grade ≥ 3 TESAEs (pooled safety population) | 16.2% | · p.131 |
| Grade ≥ 3 TEAEs (related) (control arm) | 31.8 % | · p.132 |
Source: Accord S L U ↗ · 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 →