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Epcoritamab receives approval from EC and Japan Ministry of Health, Labour and Welfare for R/R LBCL
By Sabina Ray
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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*
|
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 |
|
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. |
||
- Genmab announces European Commission approval of TEPKINLY® (epcoritamab) for adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL). https://www.businesswire.com/news/home/20230918654455/en/Genmab-Announces-European-Commission-Approval-of-TEPKINLY%C2%AE-epcoritamab-for-Adults-with-Relapsed-or-Refractory-RR-Diffuse-Large-B-cell-Lymphoma-DLBCL. Published Sept 25, 2023. Accessed Sept 26, 2023.
- EPKINLYTM (epcoritamab) approved by Japan Ministry of Health, Labour and Welfare as the first bispecific antibody to treat adults patients with certain types of relapsed or refractory (R/R) large B-cell lymphoma (LBCL). https://www.globenewswire.com/news-release/2023/09/25/2748437/0/en/EPKINLYTM-epcoritamab-Approved-by-Japan-Ministry-of-Health-Labour-and-Welfare-as-the-First-Bispecific-Antibody-to-Treat-Adults-Patients-with-Certain-Types-of-Relapsed-or-Refractory.html#:~:text=COPENHAGEN%2C%20Denmark%3B%20September%2025%2C,of%20relapsed%20or%20refractory%20large. Published Sept 25, 2023. Accessed Sept 26, 2023.
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