Drug updated on 4/16/2024
| Dosage Form | Injection (subcutaneous; 4 mg/0.8 mL in a single-dose vial, 48 mg/0.8 mL in a single-dose vial) |
| Drug Class | Bispecific CD20-directed CD3 T-cell engagers |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma after two or more lines of systemic therapy.
Summary
- Epkinly (epcoritamab-bysp) has shown potent antitumor activity as a single agent in treating B-cell non-Hodgkin lymphoma subtypes, with an overall response rate of 63.1% and complete response rate of 38.9% in patients with highly refractory large B-cell lymphoma.
- Two randomized controlled studies were analyzed to gather information about Epkinly's effectiveness and safety profile for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
- In comparison to other therapies, Epkinly demonstrated superior efficacy across different patient subgroups including those previously treated with CAR T-cell therapy, indicating its potential use within these specific populations.
- The most common adverse events associated with Epkinly include cytokine release syndrome at 49.7%, pyrexia at 23.6%, and fatigue at 22.9%. However, most cases were low-grade, making it manageable compared to severe toxicities associated with some other treatments.
- During the dose escalation phase of one study, no grade three or higher CRS events were reported nor any discontinuations due to adverse events or deaths, which further supports its favorable safety profile.
- Across key specified subgroups such as highly refractory patients and those who had prior exposure to CAR T-cells, both the effectiveness and safety profiles remained consistent, suggesting broad applicability within the adult population suffering from aggressive lymphomas like DLBCL.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Epkinly (epcoritamab-bysp) Prescribing Information. | 2023 | Genmab US, Inc., Plainsboro, NJ |
Randomized Controlled Trials
| Document Title | Sex Distribution | Year | Source |
|---|---|---|---|
| Epcoritamab, a novel, subcutaneous CD3xCD20 bispecific T-cell-engaging antibody, in relapsed or refractory large B-cell lymphoma: dose expansion in a phase I/II trial. | 157Subjects F: 40% M: 60% | 2023 | Journal of Clinical Oncology |
| Dose escalation of subcutaneous epcoritamab in patients with relapsed or refractory B-cell non-Hodgkin lymphoma: an open-label, phase 1/2 study. | 68Subjects F: 34% M: 66% | 2021 | The Lancet |
Sex Distribution:
F:40%
M:60%
157Subjects
Year:
2023
Source:Journal of Clinical Oncology
Sex Distribution:
F:34%
M:66%
68Subjects
Year:
2021
Source:The Lancet
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| NCCN guidelines support epcoritamab use in diffuse large B-cell lymphoma. | 2023 | Health and Medicine |