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

Exclusion criteria1:

  • 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:

Step-up dosing for cycle 1: 0.16 mg on day 1, 0.8 mg on day 8, 48 mg on days 15 and 22. Cycles 2-3: 48 mg on days 1, 8, 15 and 22. Cycles 4-9: 48 mg on days 1 and 15. Cycles 10+: 48 mg on day 1.

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%.

EPKINLY™ was studied across 22-83 year olds with a median age of 65. 97% of patients received a 0 or 1 and 3% received a 2 performance status from Eastern Cooperative Oncology Group. Patients had varying treatment history: median number of prior therapies was 3. 30% had 2 prior therapies, 30% had 3 prior therapies and 40% had 4 or more prior therapies. 60% of patients were primary refractory, 82% were refractory to last therapy and 39% were prior CAR T.

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.

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See EPKINLY response rates and duration of response for this patient population