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Epcoritamab receives approval from EC and Japan Ministry of Health, Labour and Welfare for R/R LBCL
On September 25, 2023, it was announced that epcoritimab received approval from both the European Commission and the Ministry of Health, Labour and Welfare of Japan for patients with relapsed/refractory diffuse large B-cell lymphoma, high-grade-B-cell lymphoma (HGBCL), primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B.1,2
Epcoritimab is the first and only T-cell engaging bispecific antibody treatment approved for this indication.1,2 The approval is based on evidence from the EPCORE NHL-1 (NCT03625037) and EPCORE NHL-3 (NCT04542824) clinical trials, which are summarized below.
Table 1. Summary of EPCORE NHL-1 and -3*
|
CR, complete response; CRS, cytokine release syndrome, DLBCL, diffuse large B-cell lymphoma, LBCL, large B-cell lymphoma; ORR, overall response rate; R/R, relapsed or refractory; TRAE, treatment-related adverse event. |
||
|
Outcome, % (unless otherwise specified) |
EPCORE NHL-11,2 |
EPCORE NHL-32 |
|---|---|---|
|
Phase |
Phase I/II |
Phase I/II |
|
Eligibility |
R/R LBCL |
R/R DLBCL post ≥2 prior lines of therapy |
|
ORR |
63 |
56 |
|
CR |
39 |
44 |
|
TRAE |
82.8 |
83.2 |
|
CRS |
49.7 |
83.3 |
|
Injection site reactions |
19.7 |
58.3 |
|
Neutropenia |
17.8 |
30.6 |
|
Lymphopenia |
— |
19.4 |
|
Decreased appetite |
— |
19.4 |
|
Thrombocytopenia |
— |
19.4 |
|
Rash |
— |
19.4 |
References
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