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 summarizes a Type II variation application for Tevimbra (tislelizumab) by Beone Medicines, seeking an extended indication for resectable NSCLC. The proposed treatment involves Tevimbra with platinum-containing chemotherapy as neoadjuvant therapy, followed by monotherapy as adjuvant treatment. Pivotal Study 315, a Phase 3 trial, demonstrated significant improvements in primary endpoints: Major Pathological Response (MPR) and Event-Free Survival (EFS), and secondary endpoints like pathological Complete Response (pCR) and Objective Response Rate (ORR) for the tislelizumab arm compared to placebo. While Overall Survival (OS) data were immature, a positive trend was observed. The report also details the immunogenicity profile, including anti-drug antibody (ADA) incidence and impact on pharmacokinetics, efficacy, and safety. Safety analysis from Study 315 showed an increase in severe adverse events, including immune-mediated pneumonitis, with tislelizumab. However, the overall benefit-risk assessment for Tevimbra in this perioperative setting was considered positive.
Key findings — cited to the page
| TEAEs >= Grade 3 (Tislelizumab Combination Therapy) | 80.0 % | · p.30 |
| Patients with ≥ Grade 3 TEAE (Tislelizumab + Chemotherapy) | 78.3 % | Study 315 · p.126 |
| TEAEs >= Grade 3 (Study 315) | 80.0 % | Study 315 · p.31 |
| Patients with ≥ Grade 3 TEAE (Placebo + Chemotherapy) | 73.5 % | Study 315 · p.126 |
| TEAEs >= Grade 3 (Tislelizumab Monotherapy) | 52.5 % | · p.30 |
| All grade im Pneumonitis in TIS Arm | 8 % | Study 315 · p.168 |
| All grade im Pneumonitis in PBO Arm | 1.8 % | Study 315 · p.168 |
| overall incidence of severe TEAEs (CTCAE ≥ Grade 3) in TIS Arm | 77.9 % | Study 315 · p.161 |
| incidence of treatment-related TEAEs of ≥ Grade 3 in TIS Arm | 72.1 % | Study 315 · p.162 |
| overall incidence of severe TEAEs (CTCAE ≥ Grade 3) in PBO Arm | 73.0 % | Study 315 · p.161 |
| incidence of treatment-related TEAEs of ≥ Grade 3 in PBO Arm | 66.4 % | Study 315 · p.162 |
| Treatment-Related Grade 3+ TEAEs (neoadjuvant phase) | 155 n | Study 315 · p.156 |
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 →