EPCORE® NHL-1: Pivotal Phase 1/2 trial that evaluated
subcutaneous EPKINLY for 3L+ FL patients1,2

An open-label, multicohort, multicenter, single-arm trial that included patients with R/R FL after 2 or more lines of systemic therapy

EPKINLY® endpoint in 2-step up dosage schedule (n=127. Primary endpoint: ORR (CR+PR) and select secondary endpoints included: CR rate, DOR, DOCR, and TTR). In 3-step up dosage schedule (n=86. Primary endpoint: Percentage of greater than grade 2 CRS events and all-grade CRS events). Dosing schedule in 2-step up dosage cycle 1 (n=127. 0.16 mg on day 1, 0.8 mg on day 8, 48 mg on days 15 and dd). Dosing schedule in 3-step up dosage cycle 1 (n=86. 0.16 mg on day 1, 0.8 mg on day 8, 3 mg on day 15, 48 mg on day 22). All patients dosing schedule (N=213. Cycles 2-3: 48 mg on days 1, 7, 15, 22. Cycles 4-9: 48 mg on days 1 and 15. Cycles 10 and beyond: 48 mg on day 1).

The 3-step up dosage schedule is the recommended dosage for patients with 3L+ FL. A separate dose optimization cohort evaluated the recommended 3-step up dosage schedule for CRS mitigation. See the recommended 3-step up dosage schedule for 3L+ patients with FL.

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

†Assessed by investigator (INV).

EPKINLY was studied in a population that included challenging-to-treat patients with R/R FL1,4-6

EPKINLY was evaluated in patients with 3L+ FL with characteristics linked to a poor prognosis

Select patient characteristics1

EPKINLY® was studied across 39­-84-year-olds with a median age of 65 (52%. n=127). 95% of patients received a 0 or 1 and 6% received a 2-performance status from Eastern Cooperative Oncology Group. Patients had varying treatment history: median number of prior therapies was 3. 36% had 2 prior therapies, 32% had 3 prior therapies and 4 or more prior therapies. 70% of patients were double refractory, 69% were refractory to last therapy and 5% were prior CAR T.

‡Defined as refractory to both anti-CD20 monoclonal antibody and alkylator therapy.7

§Refractory: Patient with no response or relapse within 6 months after therapy.7

3L=third line; CAR T=chimeric antigen T-cell therapy; CD20=cluster of differentiation 20; CNS=central nervous system; CR=complete response; CRS=cytokine release syndrome; DOCR=duration of complete response; DOR=duration of response; ECOG PS=Eastern Cooperative Oncology Group performance status; FL=follicular lymphoma; FLIPI=Follicular Lymphoma International Prognostic Index; HSCT=hematopoietic stem cell transplant; mAb=monoclonal antibody; mg=milligram; min=minute; mL=milliliter; ORR=overall response rate; PK=pharmacokinetics; PR=partial response; R/R=relapsed/refractory; TTR=time to response; ULN=upper limit of normal.

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

SEE THE CLINICAL TRIAL RESULTS