Topalliance Biosciences — Loqtorzi EMA EPAR public assessment report (EMEA/H/C/006120, 2024)
Topalliance Biosciences · 2024 · EMA EPAR public assessment report
Report summary
The EMA's assessment of Loqtorzi (toripalimab) for nasopharyngeal carcinoma (NPC) and oesophageal squamous cell carcinoma (OSCC) is detailed. The report covers the drug's mechanism, manufacturing, quality control, and non-clinical studies, confirming GMP compliance and a 36-month shelf-life. Clinical trials (JUPITER-02, JUPITER-06) demonstrated significant improvements in progression-free and overall survival for toripalimab plus chemotherapy in NPC and OSCC, with a manageable safety profile. Pharmacokinetic studies across various cancers established dose parameters and identified factors influencing PK, concluding that most do not require dose adjustments. Exposure-response analyses supported the recommended 240 mg Q3W dose. The CHMP recommended marketing authorization for both indications, despite a divergent opinion on OSCC regarding PD-L1 expression.
Key findings — cited to the page
| Grade ≥ 3 TRAEs | 50.0 % | POLARIS-02 (Cohort 6) · p.192 |
| Grade ≥ 3 TRAE | 83.9 % | JUPITER-02 (Placebo + GC) · p.190 |
| Grade ≥ 3 TRAE | 24.9 % | JUPITER-06 (Toripalimab + TP) · p.191 |
| Grade ≥ 3 TRAE | 13.6 % | JUPITER-06 (Placebo + TP) · p.191 |
| Grade ≥ 3 TEAEs | 90.2 % | JUPITER-02 (placebo arm) · p.189 |
| Grade ≥ 3 TRAE | 81.5 % | JUPITER-02 (Toripalimab + GC) · p.190 |
| Any TRAE (Grade ≥ 3) | 45.4 % | Toripalimab in Combination with Chemotherapy · p.195 |
| Grade ≥ 3 TRAEs | 58.3 % | POLARIS-02 (Cohort 7) · p.191 |
| Any TRAE (All Grades) | 59.8 % | Toripalimab Monotherapy · Western Region · p.196 |
| Any TRAE (All Grades) | 83.1 % | Toripalimab in Combination with Chemotherapy · p.195 |
| Grade ≥ 3 TEAEs | 89.7 % | JUPITER-02 (toripalimab arm) · p.189 |
| Any TRAE (All Grades) | 77.9 % | Toripalimab Monotherapy Safety Database · p.195 |
Source: Topalliance Biosciences ↗ · 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 →