EPKINLY is the first-and-only subcutaneous bispecific antibody for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS), including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma (HGBL) after 2 or more lines of systemic therapy.

This indication is approved under accelerated approval based on response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Discover efficacy data for EPKINLY

ORR was achieved in 61% (n=90/148; 95% CI, 53-69) of patients with a median DOR of 15.6 months (n=90/148; 95% CI, 9.7 mo-NR)1

  • 38% of patients achieved a complete response (n=56/148; 95% CI, 30-46)
  • 23% of patients achieved a partial response (n=34/148; 95% CI, 17-31)

EPCORE™ 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 systemic therapy (N=157). The efficacy population includes 148 patients with DLBCL, NOS, including DLBCL arising from indolent lymphoma, and HGBL.

Patients received EPKINLY monotherapy as a subcutaneous injection according to a 28-day dosing cycle schedule.* Efficacy was established based on overall response rate (ORR) determined by Lugano criteria (2014) as assessed by an Independent Review Committee (IRC) and DOR. The median follow-up for DOR was 9.8 months (range: 0-17.3 months).

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*EPKINLY is administered weekly for cycles 1-3, every other week for cycles 4 to 9, and every 4 weeks for cycles 10 and beyond.

CI=confidence interval; CR=complete response; DOR=duration of response; LBCL=large B-cell lymphoma; NR=not reached; R/R=relapsed/refractory.

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