Roche Holding AG — Lunsumio EMA EPAR public assessment report (EMEA/H/C/005680, 2022)
Roche Holding AG · 2022 · EMA EPAR public assessment report · company profile →
Report summary
The EMA assessed Lunsumio (mosunetuzumab) for relapsed or refractory follicular lymphoma, granting it orphan medicinal product designation and accelerated assessment. This T-cell-engaging bispecific antibody demonstrated high complete (60%) and objective response rates (80%) in the GO29781 clinical trial. Manufacturing processes are validated, ensuring a high-quality, stable product. Non-clinical studies showed dose-dependent B-cell depletion and T-cell activation. Pharmacokinetic and pharmacodynamic analyses revealed dose-dependent kinetics, with moderate to high inter-individual variability. Key safety concerns include cytokine release syndrome (39.3%), neutropenia, and infections. Despite the single-arm trial, conditional marketing authorization was recommended due to significant unmet medical need and promising efficacy.
Key findings — cited to the page
| Histologic transformation rate of FL to high-grade NHL | 2-3 % of patients per year | · p.11 |
| Grade 3-4 AEs in B11 RP2D cohort | 64.6 % | · p.165 |
| Grade 3 or 4 neutropenia/neutrophil count decreased in B11 RP2D cohort | 24.3 % | · p.165 |
| SAEs (excluding Grade 5 PD) for White patients | 42.9 % | · p.167 |
| Incidence of Grade 3 or 4 neutropenia/neutrophil count decreased in B11 RP2D FL cohort | 26.6 % | Study GO29781 · p.150 |
| Grade 3 and serious haemorrhagic adverse events | 1.2 % | · p.151 |
| SAEs (excluding Grade 5 PD) for Asian patients | 20.9 % | · p.167 |
| CRS events (ASTCT grading) that were Grade 1-2 in B11 RP2D cohort | 88/92 events | Study GO29781 · p.143 |
| Grade ≥3 CRS frequency | <3 % | · p.164 |
| Grade 3 or 4 neutropenia/neutrophil count decreased in B11 RP2D FL cohort | 26.6 % | · p.165 |
| Grade 3 or 4 neutropenia/neutrophil count decreased in B11 RP2D cohort | 53 patients | Study GO29781 · p.150 |
| Grade 1 or 2 CRS severity (ASTCT 2019) | 36.4% % | Study GO29781 · p.174 |
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 →