Incyte Corporation — Minjuvi EMA EPAR variation assessment report (EMEA/H/C/005436, 2021)
Incyte Corporation · 2021 · EMA EPAR variation assessment report · company profile →
Report summary
This report summarizes a Type II variation application for MINJUVI (tafasitamab) to treat relapsed or refractory follicular lymphoma (FL) in combination with lenalidomide and rituximab. The application is supported by interim results from the Phase 3 INCMOR 0208-301 (inMIND) study. This study demonstrated a statistically significant improvement in progression-free survival (PFS) for tafasitamab plus lenalidomide and rituximab compared to lenalidomide and rituximab alone in FL patients, with a median PFS of 22.37 months versus 13.93 months. The report confirms the appropriateness of the 12 mg/kg tafasitamab dose, highlighting its prolonged PFS and acceptable safety profile. While an increase in severe neutropenias and infections was observed, no new safety signals were identified, leading to a positive benefit-risk assessment for the new indication.
Key findings — cited to the page
| Grade 3 or 4 Neutropenia (tafasitamab+R2) | 41.9 % | · p.80 |
| Neutropenia (tafasitamab+R2, all grades) | 56.9 % | · p.81 |
| Febrile neutropenia Grade 3 | 2.5 % | INCMOR 0208-301 · p.96 |
| Participants with any Grade 3 or 4 TEAE (placebo+R2) | 70.5 % | · p.80 |
| Grade 3 or 4 Infections and infestations (tafasitamab+R2) | 25.7 % | · p.80 |
| Grade 3 or 4 Infections and infestations (placebo+R2) | 17.2 % | · p.80 |
| Grade 3 to 4 neutropenia | 50 % | · p.11 |
| Febrile neutropenia Grade 3 | 2.4 % | INCMOR 0208-301 · p.96 |
| Neutropenia (tafasitamab+R2, Grade 3-4) | 46.8 % | · p.81 |
| Participants with any Grade 3 or 4 TEAE (tafasitamab+R2) | 72.8 % | · p.80 |
| Grade 3 or 4 Neutropenia (placebo+R2) | 39.7 % | · p.80 |
| Neutropenia (placebo+R2, all grades) | 54.2 % | · p.81 |
Source: Incyte Corporation ↗ · 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 →