Roche Holding AG — Columvi EMA EPAR public assessment report (EMEA/H/C/005751, 2023)
Roche Holding AG · 2023 · EMA EPAR public assessment report · company profile →
Report summary
The European Medicines Agency (EMA) assessed Columvi (glofitamab) for conditional marketing authorization as monotherapy for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. The T-cell bispecific antibody demonstrated acceptable quality, and preclinical studies showed dose-dependent tumor cell lysis and anti-tumor activity. Clinical efficacy from Study NP30179, Cohort D3, revealed a 35.2% complete response rate with a median duration of response of 14.4 months in heavily pre-treated patients. Key safety concerns include cytokine release syndrome (CRS), blood disorders, and infections, which are generally manageable. Columvi offers a potential benefit, including for patients who failed CAR-T therapy, and the CHMP recommended conditional marketing authorization.
Key findings — cited to the page
| Grade ≥ 2 ALT, AST, or total bilirubin elevation | 7.1 % | glofitamab · p.123 |
| Grade 3 TLS AE | 1.3 % | glofitamab · p.122 |
| Grade ≥ 3 febrile neutropenia | 2.6 % | glofitamab · p.122 |
| Grade ≥ 2 CRS AEs (ASTCT 2019) | 41/195 | glofitamab · p.116 |
| Grade ≥ 2 neurological AE | 14.3 % | glofitamab · p.121 |
| Grade ≥ 2 NAEs | 16.4 % | glofitamab · p.121 |
| CRS AEs of any grade (ASTCT 2019) | 64.3 % | glofitamab · p.114 |
| Tumour flare of any grade | 11.0 % | glofitamab · p.120 |
| CRS AEs of any grade (ASTCT 2019) | 66.1 % | glofitamab · p.114 |
| Grade ≥ 2 CRS AEs (ASTCT 2019) | 16.2 % | glofitamab · p.116 |
| Tumour flare ≥ Grade 2 | 7.1 % | glofitamab · p.120 |
| CRS AEs of any grade (Lee et al 2014) | 66.9 % | glofitamab · p.141 |
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 →