Hetronifly(serplulimab)
Oncology· 690 cited findings· 2 source documents
Company: Accord S L U
What the regulatory reviews say
Hetronifly (serplulimab) is an orphan medicinal product (EU/3/22/2731, designated 9 December 2022) with a proposed new therapeutic indication for the first-line treatment of adult patients with unresectable, locally advanced or metastatic squamous non-small cell lung carcinoma. The marketing authorisation application was submitted on 2 March 2023, with a CHMP positive opinion date of 19 September 2024.
In the pivotal study HLX10-004-NSCLC303, serplulimab demonstrated a median overall survival of 15.8 months compared to 11.1 months in the control arm, with an Overall Survival Hazard Ratio of 0.62. The median progression-free survival (iRECIST) by investigator was 5.7 months for serplulimab and 4.4 months for the control arm, with a Hazard Ratio of 0.56.
Regarding safety, 98.9% of patients in the serplulimab arm experienced treatment-emergent adverse events (TEAEs), with 73.2% being serplulimab-related. TEAEs leading to discontinuation occurred in 16.8% of the serplulimab arm (8.7% related) compared to 12.8% in the control arm (4.5% related). TEAEs leading to death (related) were 1.1% in both the serplulimab and control arms. The recommended dose of serplulimab is 4.5 mg/kg.
Key figures — cited to the source page
| Median overall survival (serplulimab) | 15.8 | Accord S L U — Hetronifly EMA EPAR public assessment report, p.89 |
| Median overall survival (control) | 11.1 | Accord S L U — Hetronifly EMA EPAR public assessment report, p.89 |
| Overall Survival Hazard Ratio | 0.62 | Accord S L U — Hetronifly EMA EPAR public assessment report, p.89 |
| Median PFS (iRECIST) by investigator (serplulimab) | 5.7 | Accord S L U — Hetronifly EMA EPAR public assessment report, p.76 |
| Median PFS (iRECIST) by investigator (control) | 4.4 | Accord S L U — Hetronifly EMA EPAR public assessment report, p.76 |
| TEAEs leading to discontinuation (serplulimab arm) | 16.8 | Accord S L U — Hetronifly EMA EPAR variation assessment repo, p.132 |
| TEAEs leading to discontinuation (control arm) | 12.8 | Accord S L U — Hetronifly EMA EPAR variation assessment repo, p.132 |
| CHMP positive opinion date | 19 September 2024 | Accord S L U — Hetronifly EMA EPAR public assessment report, p.14 |
Source documents
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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.