Roche Holding AG — Zelboraf EMA EPAR variation assessment report (EMEA/H/C/002409, 2012)
Roche Holding AG · 2012 · EMA EPAR variation assessment report · company profile →
Report summary
This report assesses the paediatric study BRIM-P/NO25390 for Zelboraf (vemurafenib) in adolescent patients with BRAF V600-positive metastatic melanoma. The study experienced severe recruitment issues, enrolling only 6 of 23-35 planned patients. Efficacy was poor, with no confirmed responses, a median progression-free survival of 134.5 days, and a median overall survival of 246.5 days, appearing worse than adult data. Safety profiles were generally consistent with adults, but the limited data precluded determining a maximum tolerated dose or an acceptable upper daily dose for adolescents.
Key findings — cited to the page
| number of patients enrolled | 6 | BRIM-P (NO25390) · p.2 |
| age range of patients | 12-17 years | BRIM-P (NO25390) · p.2 |
| trial phase | Phase I | BRIM-P (NO25390) · p.3 |
| patient inclusion criteria | BRAF V600 mutations | BRIM-P (NO25390) · p.3 |
| planned enrollment | 23-35 patients | BRIM-P (NO25390) · p.5 |
| actual enrollment | 6 patients | BRIM-P (NO25390) · p.12 |
| best overall response rate (CR or PR) | 0 % | NO25390 · p.9 |
| clinical benefit rate (SD for at least 6 weeks) | 66.7 % | NO25390 · p.9 |
| median progression-free survival | 134.5 days | NO25390 · p.9 |
| median overall survival | 246.5 days | NO25390 · p.9 |
| median overall survival (vemurafenib arm) | 13.6 months | NO25026 · p.9 |
| median progression-free survival | 6.9 months | NO25026 · p.9 |
Source: Roche Holding AG ↗ · 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 →