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).
*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.