Product Description
Naratuximab emtansine (Debio 1562), an antibody-drug conjugate (ADC) targeting CD37, is a potential new treatment for patients with B-cell malignancies, such as non-Hodgkin's lymphomas (NHL). Naratuximab emtansine (Debio 1562) demonstrated evidence of anti-cancer activity in NHL in a Phase 1 monotherapy trial and successfully completed a safety lead-in study in combination with rituximab. The product is currently in phase IIb in relapsed/refractory diffuse large-cell B-cell lymphoma (R/R DLBCL) for which it benefits from Orphan Drug status. Naratuximab emtansine has also shown promising signs of efficacy in Marginal Zone Lymphoma and Follicular Lymphoma and has potential in Acute Myeloid Leukemia. (Sourced from: https://www.debiopharm.com/pipeline/debio-1562/)
Mechanisms of Action: CD37 Inhibitor
Novel Mechanism: Yes
Modality: Antibody Drug Conjugate
Route of Administration: Intravenous
FDA Designation: *
Approval Status: Not Approved
Approved Countries: None
Approved Indications: None
Known Adverse Events: None
Company: Debiopharm
Company Location:
Company CEO:
Additional Commercial Interests: None
Clinical Description
Countries in Clinic:
Active Clinical Trial Count:
Recent & Upcoming Milestones
Highest Development Phases
Phase 2: Diffuse Large B-Cell Lymphoma|Lymphoma, Non-Hodgkin
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
2015-004061-87 |
2015-004061-87 | P2 |
Completed |
Lymphoma, Non-Hodgkin|Diffuse Large B-Cell Lymphoma |
2021-06-25 |
47% |
2025-07-09 |
Treatments |
NCT02564744 |
Debio 1562-201 | P2 |
Completed |
Diffuse Large B-Cell Lymphoma|Lymphoma, Non-Hodgkin |
2021-01-13 |
47% |
2024-06-28 |
Primary Endpoints|Treatments |