EPKINLY, a subcutaneous bispecific for DLBCL,
was evaluated in EPCORETM NHL-11

An open-label, multicohort, multicenter, single-arm trial that studied EPKINLY in patients with R/R LBCL after 2 or more lines of systemic therapy (N=157). Efficacy was evaluated in 148 patients with DLBCL, NOS, including DLBCL arising from indolent lymphoma, and HGBL.

EPCORE NHL-1 trial

Primary endpoint*: ORR (CR+PR)

 

Select secondary endpoints included2*: 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

KEY EXCLUSION CRITERIA:

CNS involvement of lymphoma | Allogeneic HSCT or solid organ transplant | Ongoing active infection | Known impaired T-cell immunity

 

 

 

 

 

 

DOSING SCHEDULE

SUBCUTANEOUS EPKINLY 48 mg

  • Weekly, cycles 1†-3
  • Every other week, cycles 4-9
  • Every 4 weeks, cycles 10+

 

Cycle=28 days.

Patients continued to receive EPKINLY until disease progression or unacceptable toxicity.

Strategies to minimize occurrence and severity of CRS:

  • Step-up dosing: step-up dose 1 of 0.16 mg on C1D1, step-up dose 2 of 0.8 mg on C1D8, and full dose of 48 mg on C1D15. Patient should be hospitalized for 24 hours after C1D15 dosage of 48 mg
  • Prophylactic treatment with corticosteroids, antihistamines, and antipyretics during C1 and as needed during C2+

Please see the Dosing Information and full Prescribing Information for recommended dosing schedule and prophylaxis.

EPKINLY was evaluated in heavily pretreated 3L+ DLBCL patients1

Patient characteristics

EPKINLY was studied in a population of patients with complex treatment histories.

The diagnosis was DLBCL NOS in 86%, including 27% with DLBCL transformed from indolent lymphoma, 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.

*Efficacy results determined by Lugano criteria (2014) as assessed by Independent Review Committee (IRC).

†Step-up dosing occurs in cycle 1 of EPKINLY on the following schedule: 0.16 mg on day 1, 0.8 mg on day 8, 48 mg on days 15 and 22.

‡A patient is considered to be primary refractory if their disease is refractory to first-line antilymphoma therapy.

3L=third line; ASCT=autologous stem cell transplant; C1=cycle 1; C2=cycle 2; C1D1=cycle 1 day 1; C1D8=cycle 1 day 8; C1D15=cycle 1 day 15; CAR T=chimeric antigen receptor T-cell therapy; 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; FL=follicular lymphoma; HGBL=high-grade B-cell lymphoma; HSCT=hematopoietic stem cell transplant; LBCL=large B-cell lymphoma; mAb=monoclonal antibody; NOS=not otherwise specified; ORR=overall response rate; PMBCL=primary mediastinal large B-cell lymphoma; PS=performance status; R/R=relapsed/refractory.

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

SEE THE CLINICAL TRIAL RESULTS