AbbVie Inc. — Tepkinly EMA EPAR variation assessment report (EMEA/H/C/005985, 2023)
AbbVie Inc. · 2023 · EMA EPAR variation assessment report · company profile →
Report summary
This report summarizes AbbVie's Type II variation application for Tepkinly (epcoritamab), seeking an extended indication for relapsed/refractory follicular lymphoma (R/R FL) in combination with rituximab and lenalidomide (R2). The application is supported by interim results from the Phase 3 study M20-638 and Phase 1b/2 study GCT3013-02. Pharmacokinetic and pharmacodynamic analyses confirm epcoritamab's mechanism and an exposure-response relationship, with higher doses (48 mg) correlating with improved outcomes. Study M20-638 demonstrated significant improvements in progression-free survival, overall response rate, and overall survival for the epcoritamab + R2 arm compared to R2 alone, supporting the efficacy of the combination therapy for R/R FL.
Key findings — cited to the page
| CR rate for Epcoritamab 48mg (Cohort 2b Dose expansion part) | 86.9 % | · p.71 |
| DOR for Epcoritamab 48mg (Cohort 2b Dose expansion part) | NR | · p.71 |
| ORR for Epcoritamab 48 mg + R2 (Expansion Part) | 96.3 % | · p.71 |
| CR rate for Epcoritamab 48 mg + R2 (Expansion Part) | 88.0 % | · p.71 |
| median DOR for Epcoritamab 48 mg + R2 (Expansion Part) | NR | · p.71 |
| estimated percentage of subjects remaining in response at 12 months | 84.1 % | · p.71 |
| estimated percentage of subjects remaining in response at 24 months | 75.6 % | · p.71 |
| median DOCR for Epcoritamab 48 mg + R2 (Expansion Part) | NR | · p.71 |
| Type II variation application submission date | 10 November 2025 | Tepkinly · p.6 |
| Proposed new therapeutic indication | Tepkinly in combination with lenalidomide and rituximab is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL). | Tepkinly · p.6 |
| Trial phase | Phase 3 | M20-638 (EPCORE FL-1) · p.6 |
| ORR for Epcoritamab 48mg (Cohort 2b Dose expansion part) | 97.6 % | · p.71 |
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 →