Drug updated on 10/21/2024
| Dosage Form | Injection (subcutaneous; 4 mg/0.8 mL , 48 mg/0.8 mL) |
| 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
- Indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.
Latest News
Summary
- This summary is based on the review of three randomized controlled trial(s). [1-3]
- In patients with relapsed or refractory follicular lymphoma, the overall response rate (ORR) was 82.0% (95% CI: 74.3-88.3), with a complete response rate (CRR) of 62.5% (95% CI: 53.5-70.9). In adults with relapsed or refractory CD20(+) large B-cell lymphoma, the ORR was 63.1% (95% CI: 55.0-70.6), with a CRR of 38.9% (95% CI: 31.2-46.9).
- In adults with relapsed or refractory diffuse large B-cell lymphoma, the ORR at full doses was 68% (95% CI: 45-86) and the CRR was 45%. In patients with relapsed or refractory follicular lymphoma, the ORR was 90% (95% CI: 55-100), with a CRR of 50%.
- Across studies, high response rates were observed regardless of lymphoma subtype, with notable effectiveness in both diffuse large B-cell lymphoma and follicular lymphoma subgroups, providing promising outcomes in heavily pretreated patients.
- In patients with relapsed or refractory follicular lymphoma, common adverse events included grade 3-4 neutropenia (25%), grade 1-2 cytokine release syndrome (CRS) (65%), and immune effector cell-associated neurotoxicity syndrome (ICANS) (6%). In the cycle 1 optimization cohort, CRS incidence was reduced to 49%, with no cases of grade 3 or higher CRS.
- In adults with relapsed or refractory CD20(+) large B-cell lymphoma, CRS occurred in 49.7% of patients (grade 3: 2.5%) and ICANS in 6.4% of patients, including one fatal ICANS event.
- Document 1 included a subgroup analysis of patients with relapsed or refractory follicular lymphoma, showing that the cycle 1 optimization cohort (median age 64 years) had reduced cytokine release syndrome (CRS) severity. Document 2 examined adults with relapsed or refractory CD20(+) large B-cell lymphoma, including 38.9% with prior CAR T-cell exposure, demonstrating consistent effectiveness and safety outcomes across these subgroups. Document 3 provided specific efficacy results for diffuse large B-cell lymphoma and follicular lymphoma subgroups, showing high overall response rates.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Epkinly (epcoritamab-bysp) Prescribing Information. | 2024 | Genmab US, Inc., Plainsboro, NJ |
Randomized Controlled Trials
| Document Title | Sex Distribution | Year | Source |
|---|---|---|---|
| Epcoritamab monotherapy in patients with relapsed or refractory follicular lymphoma (EPCORE NHL-1): a phase 2 cohort of a single-arm, multicentre study | 214Subjects F: 40% M: 60% | 2024 | The Lancet Haematology |
| 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%
214Subjects
Year:
2024
Source:The Lancet Haematology
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 |