Incyte Corporation — Minjuvi EMA EPAR public assessment report (EMEA/H/C/005436, 2021)
Incyte Corporation · 2021 · EMA EPAR public assessment report · company profile →
Report summary
The EMA granted conditional marketing authorization for Minjuvi (tafasitamab) on June 24, 2021, for relapsed/refractory diffuse large B-cell lymphoma (DLBCL) patients ineligible for autologous stem cell transplant. Manufacturing and quality control of tafasitamab were assessed, alongside extensive non-clinical studies demonstrating its mechanism of action (CD19 binding, ADCC, ADCP, direct cytotoxicity) and anti-tumor efficacy, particularly in combination with lenalidomide. Pharmacokinetic and toxicological data from cynomolgus monkeys showed B-lymphocyte depletion and recovery. Clinical pharmacology revealed a two-compartment linear disposition model with time-dependent clearance. The pivotal L-MIND study (tafasitamab + lenalidomide) in relapsed/refractory DLBCL patients showed an objective response rate of 56.8% and a complete response rate of 39.5%, with a median duration of response of 34.6 months. Safety analysis indicated that Blood and Lymphatic System Disorders and Infections were the most frequent adverse events, with higher incidence in combination therapy, largely attributed to lenalidomide. Despite limitations of the single-arm study, the combination demonstrated clinically meaningful efficacy. Post-authorization measures, including further studies, are required to confirm long-term efficacy and safety.
Key findings — cited to the page
| Patients with Grade 3/4 Lymphocytes shift from baseline in Pooled Monotherapy Studies | 14.3 % | · p.123 |
| Patients with Grade 3/4 Neutrophils shift from baseline in Pooled Monotherapy Studies | 24.5 % | · p.123 |
| Patients with Grade 3/4 Haemoglobin shift from baseline in Pooled Monotherapy Studies | 2.0 % | · p.123 |
| Patients with Grade 3/4 Leukocytes shift from baseline in MOR208C203 | 9.9 % | MOR208C203 · p.123 |
| Patients with Grade 3/4 Leukocytes shift from baseline in Pooled Monotherapy Studies | 22.4 % | · p.123 |
| Patients with Grade 3/4 Lymphocytes shift from baseline in MOR208C203 | 4.9 % | MOR208C203 · p.123 |
| Patients with non-allergic skin events (any grades) in pooled monotherapy studies | 9.9 % | · p.117 |
| Grade 3 or higher allergic reaction events | 4 | MOR208C203 · p.115 |
| Patients with non-allergic skin events (any grades) in MOR208C203 | 37.0 % | MOR208C203 · p.117 |
| Patients with Grade 3 non-allergic skin reactions in MOR208C203 | 4 | MOR208C203 · p.117 |
| Patients with Grade 3/4 Haemoglobin shift from baseline in MOR208C203 | 1.2 % | MOR208C203 · p.123 |
| Patients with Grade 3/4 Neutrophils shift from baseline in MOR208C203 | 17.3 % | MOR208C203 · p.123 |
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 →