BeOne Medicines Ltd. — Tevimbra EMA EPAR public assessment report (EMEA/H/C/005919, 2023)
BeOne Medicines Ltd. · 2023 · EMA EPAR public assessment report · company profile →
Report summary
The EMA granted a positive opinion for marketing authorization of Tevimbra (tislelizumab) for unresectable, recurrent, locally advanced or metastatic oesophageal squamous cell carcinoma (OSCC) after prior chemotherapy. The IgG4 monoclonal antibody, produced in CHO cells, demonstrated robust quality control and stability. Non-clinical and clinical pharmacology studies characterized its pharmacokinetics, including covariate impacts and immunogenicity. Pivotal Phase 3 Study 302 showed superior overall survival, progression-free survival, and objective response rates for tislelizumab compared to investigator-chosen chemotherapy, especially in PD-L1 positive patients. While some baseline imbalances were noted, sensitivity analyses confirmed efficacy. The safety profile, including immune-mediated adverse events, was manageable and generally favorable compared to chemotherapy, supporting a positive benefit-risk balance.
Key findings — cited to the page
| Grade ≥ 3 AEs in Metabolism and nutrition disorders (ADA-negative) | 7.3 % | tislelizumab monotherapy · p.65 |
| Grade ≥ 3 AEs in Gastrointestinal disorders (ADA-positive) | 9.1 % | tislelizumab monotherapy · p.65 |
| Grade ≥ 3 AEs in Metabolism and nutrition disorders (ADA-positive) | 11.6 % | tislelizumab monotherapy · p.65 |
| Grade ≥ 3 AEs in combination therapy (ADA-positive) | 85.6 % | tislelizumab combination therapy · p.65 |
| Grade ≥ 3 AEs in Investigations SOC (ADA-positive) | 12.9 % | tislelizumab monotherapy · p.65 |
| Grade ≥ 3 AEs in Blood and lymphatic system disorders (ADA-negative) | 5.3 % | tislelizumab monotherapy · p.65 |
| Grade ≥ 3 AEs in Blood and lymphatic system disorders (ADA-positive) | 9.9 % | tislelizumab monotherapy · p.65 |
| Grade ≥ 3 AEs in Investigations SOC (ADA-negative) | 10.3 % | tislelizumab monotherapy · p.65 |
| Grade ≥ 3 AEs in monotherapy (ADA-positive) | 50.9 % | tislelizumab monotherapy · p.65 |
| Grade ≥ 3 AEs in monotherapy (ADA-negative) | 39.3 % | tislelizumab monotherapy · p.65 |
| Grade ≥ 3 AEs in combination therapy (ADA-negative) | 78.2 % | tislelizumab combination therapy · p.65 |
| Grade ≥ 3 AEs in Gastrointestinal disorders (ADA-negative) | 5.7 % | tislelizumab monotherapy · p.65 |
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 →