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STUDY DESIGN & CLINICAL CHARACTERISTICS
The EPCORE™ NHL-1 trial evaluated subcutaneous TEPKINLY in a broad range* of patients with DLBCL1,2
Efficacy was evaluated in 139 patients with DLBCL during a phase 2 (dose expansion) study1
EPCORE NHL-1 was an open-label, multicohort, multicentre, single-arm trial that evaluated TEPKINLY as monotherapy in patients with R/R LBCL, including DLBCL, after 2 or more lines of systemic therapy.1
KEY INCLUSION CRITERIA2:
R/R CD20+ mature B-cell neoplasm
ECOG PS 0-2
Prior CAR T allowed
≥2 prior lines of antineoplastic therapy, including ≥1 anti-CD20 mAb2
PRIMARY ENDPOINT
ORR
SECONDARY ENDPOINTS INCLUDED
OS, DOR, CR rate, CR duration, time to response, safety/tolerability, PFS2
*EPCORE NHL-1 trial enrolled patients with ECOG status 0-2, de novo DLBCL, DLBCL transformed from indolent lymphoma, CAR T naïve, prior CAR T, and primary refractory disease.2
Median follow-up: 10.7 months.1
Patients continued to receive TEPKINLY until disease progression or unacceptable toxicity.2
Patients had complex treatment histories that included CAR T therapy1
Demographics and baseline characteristics of patients with DLBCL in EPCORE NHL-1
| Characteristics | (N=139) |
|---|---|
| Median Age, year | 66 (range: 22-83) |
| Male | 61% |
| ECOG PS | |
| 0 | 48% |
| 1 | 48% |
| 2 | 4% |
| Race | |
| White | 60% |
| Asian | 19% |
| Other | 4% |
| Not Reported | 17% |
aA patient is considered to be primary refractory if the patient is refractory to frontline antilymphoma therapy.
bA patient is considered to be refractory if the patient either experiences disease progression during therapy or disease progression within 6 months after therapy completion. A patient is considered relapsed if the patient had recurred disease ≥6 months after therapy completion.
Treatment history in patients with DLBCL in EPCORE NHL-1
| Treatment History | |
|---|---|
| Median Number of Prior Therapies: 3 (range: 2-11) | |
| 2 | 30% |
| 3 | 34% |
| ≥4 | 37% |
| Disease Type at Study Entry | |
| DLBCL | 100% |
| DLBCL Disease History | |
| De novo DLBCL | 70% |
| DLBCL transformed from indolent lymphoma | 29% |
| FISH Analysis per Central Lab, n=88 | |
| Double-hit/triple-hit lymphoma | 14% |
| Prior Therapy | |
| Prior CAR T | 38% |
| Prior autologous HSCT | 19% |
| Primary refractory diseasea | 59% |
| Refractory to ≥2 consecutive lines of prior antilymphoma therapyb | 75% |
| Refractory to the last line of systemic antineoplastic therapyb | 82% |
| Refractory to prior anti-CD20 therapy | 84% |
| CAR T naïve | 62% |
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Explore efficacy data from the EPCORE NHL-1 study.
CAR T=chimeric antigen T cell; CD20=cluster of differentiation 20; CR=complete response; DLBCL=diffuse large B-cell lymphoma; DOR=duration of response; ECOG PS=Eastern Cooperative Oncology Group performance status; FISH=fluorescence in situ hybridization; HSCT=hematopoietic stem cell transplant; LBCL=large B-cell lymphoma; mAb=monoclonal antibody; NHL=non-Hodgkin lymphoma; ORR=overall response rate; OS=overall survival; PFS=progression-free survival; R/R=relapsed/refractory.
TEPKINLY as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.1
References: 1. TEPKINLY Summary of Product Characteristics. AbbVie Inc. 2. Thieblemont C, Phillips T, Ghesquieres H, et al. 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. J Clin Oncol. Published online December 22, 2022. doi:10.1200/JCO.22.01725
ALL-EPCOR-230034