AbbVie Inc. — Tepkinly EMA EPAR public assessment report (EMEA/H/C/005985, 2023)
AbbVie Inc. · 2023 · EMA EPAR public assessment report · company profile →
Report summary
AbbVie Deutschland GmbH & Co. KG applied for conditional marketing authorization for Tepkinly (epcoritamab) to treat relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more systemic therapies. Epcoritamab, an orphan medicinal product, is a bispecific antibody targeting CD20-expressing cells, demonstrating potent T-cell activation and anti-tumor activity in non-clinical studies. Clinical trials (GCT3013-01 and GCT3013-04) established a subcutaneous step-up dosing regimen (0.16 mg, 0.8 mg, then 48 mg). Efficacy data from the GCT3013-01 study showed an overall response rate of 63.1% and a complete response rate of 38.9% in large B-cell lymphoma, with a median duration of response of 15.5 months. Key safety concerns include cytokine release syndrome (50.3%) and immune effector cell-associated neurotoxicity syndrome (6.0%), with 7.2% fatal treatment-emergent adverse events. The EMA recommended conditional marketing authorization, with confirmatory studies ongoing.
Key findings — cited to the page
| subjects with Grade 3 and higher related TEAE | 47 | GCT3013-01 · p.126 |
| grade 3 or 4 CRS in GCT3013-01 MCL expansion cohort | 10.8 % | GCT3013-01 · p.126 |
| subjects with Grade 3 and higher TEAE | 105 | GCT3013-01 · p.126 |
| subjects with grade 3 or higher TEAEs related to epcoritamab | 47 | GCT3013-01 · p.125 |
| grade 3 or higher ICANS | 1 | GCT3013-01 · p.125 |
| grade 3 or higher CTLS | 2 | GCT3013-01 · p.125 |
| Grade 1 CRS | 31.1 % | · p.203 |
| grade 3 or higher CRS | 4 | GCT3013-01 · p.125 |
| Grade 2 CRS | 16.8 % | · p.203 |
| subjects with at least 1 grade 3 or higher TEAE | 105 | GCT3013-01 · p.125 |
| Grade 3 CRS | 2.4 % | · p.203 |
| Grade 2 ICANS | 1.2 % | · p.203 |
Source: AbbVie Inc. ↗ · 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 →