Accord S L U — Hetronifly EMA EPAR public assessment report (EMEA/H/C/006170, 2025)
Accord S L U · 2025 · EMA EPAR public assessment report
Report summary
The EMA granted a positive opinion for marketing authorization of Hetronifly (serplulimab) on September 19, 2024, for first-line treatment of extensive-stage small cell lung cancer (ES-SCLC) in combination with carboplatin and etoposide. Hetronifly is a humanized anti-PD-1 monoclonal antibody that enhances T-cell anti-tumor responses. Non-clinical studies in monkeys showed good tolerability and identified immune-related adverse effects. Clinical studies, including the pivotal Phase III ASTRUM-005 trial, investigated various dosing regimens, safety, pharmacokinetics, and efficacy. ASTRUM-005, a double-blind randomized controlled trial in 567 ES-SCLC patients, demonstrated significant improvements in overall survival (median 15.38 vs 10.91 months) and progression-free survival for the serplulimab group. The report also details recommended posology, treatment modifications for adverse reactions, and quality aspects. Serplulimab's pharmacokinetics are comparable to other IgG4 antibodies, and while PD-1 receptor occupancy is achieved, no clear predictive biomarkers were identified.
Key findings — cited to the page
| median PFS (RECIST 1.1) by IRRC | 6.1 months | ASTRUM-005 · Asian · p.83 |
| median PFS (RECIST 1.1) by IRRC | 5.0 months | ASTRUM-005 · non-Asian · p.81 |
| median PFS (RECIST 1.1) by IRRC | 5.7 months | ASTRUM-005 · non-Asian · p.81 |
| median PFS (RECIST 1.1) by IRRC | 4.3 months | ASTRUM-005 · Asian · p.83 |
| median PFS (RECIST 1.1) by IRRC | 4.3 months | ASTRUM-005 · Asian · p.83 |
| median PFS (RECIST 1.1) by IRRC | 5.8 months | ASTRUM-005 · Asian · p.83 |
| median PFS (RECIST 1.1) by IRRC | 5.6 months | ASTRUM-005 · non-Asian · p.81 |
| median PFS (RECIST 1.1) by IRRC | 4.7 months | ASTRUM-005 · non-Asian · p.81 |
| CHMP positive opinion date | 19 September 2024 | Hetronifly · EU · p.14 |
| SCLC patients presenting with metastatic disease | 70% | · p.16 |
| Marketing authorisation application submission date | 2 March 2023 | Hetronifly · EU · p.12 |
| Orphan medicinal product designation number | EU/3/22/2731 | Hetronifly (serplulimab) · EU · p.12 |
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 →