EPCORETM NHL-1 trial1
EPKINLY was evaluated based on results from EPCORE NHL-1, an open-label, multicohort, multicenter, single-arm trial in patients with R/R LBCL after 2 or more lines of systematic therapy (N=157). The efficacy population includes 148 patients with DLBCL, NOS, including DLBCL arising from indolent lymphoma, and HGBL.
Primary endpoints2*: ORR (CR+PR)
Select secondary endpoints2: CR rate, DOR, DOCR, time to response
Key inclusion criteria3:
- ECOG PS 0-2
- Prior CAR T allowed
- ≥2 prior lines of antineoplastic therapy, including ≥1 anti-CD20 mAb
- CNS involvement of lymphoma
- Allogeneic HSCT or solid organ transplant
- Ongoing active infection
- Any patients with known impaired T-cell immunity
Patients received EPKINLY according to the following 28-day cycle schedule:
Patients continued to receive EPKINLY until disease progression or unacceptable toxicity.
*Determined by Lugano criteria (2014) as assessed by Independent Review Committee (IRC).
†0.16 mg is step-up dose 1; 0.8 mg is step-up dose 2; and 48 mg is a full dose.
The efficacy population included R/R DLBCL patients (N=148) with varying
treatment histories, including prior CAR T4
The diagnosis was DLBCL NOS in 86%, including 27% with DLBCL transformed from indolent lymphoma, and HGBL in 14%.
‡A patient is considered to be primary refractory if their disease is refractory to first-line antilymphoma therapy.
ASCT=autologous hematopoietic stem cell transplant; CAR T=chimeric antigen receptor T cell; CD20=cluster of differentiate 20; CNS=central nervous system; CR=complete response; DLBCL=diffuse large B-cell lymphoma; DOCR=duration of complete response; DOR=duration of response; ECOG PS=Eastern Cooperative Oncology Group performance status; HGBL=high-grade B-cell lymphoma; HSCT=hematopoietic stem cell transplant; LBCL=large B-cell lymphoma; mAb=monoclonal antibody; NHL=non-Hodgkin lymphoma; NOS=not otherwise specified; ORR=overall response rate; PR=partial response; R/R=relapsed/refractory.
See EPKINLY response rates and duration of response for this patient population