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 a Type II variation application for Tevimbra (tislelizumab) to extend its indication for first-line treatment of extensive-stage small cell lung cancer (ES-SCLC) in combination with etoposide and platinum chemotherapy. The application is based on final results from the Phase 3, randomized, double-blind, placebo-controlled Study BGB-A317-312. This study met its primary endpoint of overall survival, demonstrating statistically significant improvement for the tislelizumab arm. Secondary endpoints, including progression-free survival and objective response rates, also favored the tislelizumab combination. The report includes pharmacokinetic data, immunogenicity analysis, and the impact of anti-drug antibodies, noting comparable ADA incidence across smoking statuses but slightly elevated rates in older patients and those with ECOG PS II. Subgroup and sensitivity analyses were performed, and comparisons to other ICI trials were made, noting some differences in patient characteristics compared to typical EU ES-SCLC populations.
Key findings — cited to the page
| Patients with death | 10 | Study 206 · p.74 |
| Median OS | 15.5 months | Study 206 · p.74 |
| Survival rate at 12-month | 75 % | Study 206 · p.74 |
| Survival rate at 18-month | 38 % | Study 206 · p.74 |
| patients enrolled in Study 312 | 457 | Study 312 · China · p.74 |
| median age of enrolled patients | 62 years | Study 312 · p.75 |
| Confirmed INV-DOR | 3.7 months | RATIONALE 312 · p.73 |
| Type II variation application submission date | 3 October 2024 | Tevimbra (tislelizumab) · p.7 |
| Proposed new indication | Tevimbra, in combination with etoposide and platinum chemotherapy, is indicated for the first-line treatment of adult patients with extensive-stage SCLC. | Tevimbra (tislelizumab) · p.8 |
| Number of patients enrolled in Study 312 | 457 | BGB-A317-312 · Global · p.12 |
| Number of patients receiving tislelizumab in Study 312 | 227 | BGB-A317-312 · p.12 |
| Event free rate at 12-month | 25.3 % | Study 206 · p.74 |
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 →