BeOne Medicines Ltd. — Tevimbra EMA EPAR variation assessment report (EMEA/H/C/005919, 2023)
BeOne Medicines Ltd. · 2023 · EMA EPAR variation assessment report · company profile →
Report summary
This report details the Type II variation approval for Tevimbra (tislelizumab) to treat first-line recurrent or metastatic nasopharyngeal carcinoma (NPC) in combination with gemcitabine and cisplatin. Based on the Phase 3 Study BGB-A317-309, the application demonstrated significant improvements in progression-free survival (PFS), objective response rates (ORR), and overall survival (OS) for the tislelizumab arm compared to placebo plus chemotherapy. The study also provided pharmacokinetic and immunogenicity data, noting the incidence and impact of anti-drug antibodies. Safety analysis confirmed the profile of tislelizumab plus chemotherapy. The CHMP's decision necessitates updates to product information.
Key findings — cited to the page
| TEAEs Grade ≥3 in White ADA-positive population | 78.8 % | tislelizumab combination therapy studies · White · p.40 |
| TEAEs Grade ≥3 in White ADA-negative population | 68.5 % | tislelizumab combination therapy studies · White · p.40 |
| TEAEs ≥ grade 3 in ADA-positive population (integrated analysis) | 80.0 % | integrated analysis (including Study 315) · p.40 |
| TEAEs Grade ≥3 in Asian ADA-negative population | 79.9 % | tislelizumab combination therapy studies · Asian · p.40 |
| TEAEs Grade ≥3 in Europe/NA ADA-positive population | 78.4 % | tislelizumab combination therapy studies · Europe/North America · p.40 |
| TEAEs Grade ≥3 in Europe/NA ADA-negative population | 67.8 % | tislelizumab combination therapy studies · Europe/North America · p.40 |
| incidence of IRRs in ADA-positive population | 18.2 % | Study 309 · p.39 |
| incidence of IRRs in ADA-negative population | 4.4 % | Study 309 · p.39 |
| TEAEs ≥ grade 3 in ADA-negative population (integrated analysis) | 78.6 % | integrated analysis (including Study 315) · p.40 |
| TEAEs Grade ≥3 in Asian ADA-positive population | 80.1 % | tislelizumab combination therapy studies · Asian · p.40 |
| TEAEs >= Grade 3 in Tislelizumab + Chemotherapy arm | 85.0 % | Study 309 · p.99 |
| TEAEs >= Grade 3 in Placebo + Chemotherapy arm | 85.4 % | Study 309 · p.99 |
Source: BeOne Medicines Ltd. ↗ · 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 →