EPCORE® FL-1: designed for a broad eligibility of FL patients with fixed-duration EPKINLY + R2 1,2

The efficacy and safety of EPKINLY + R2 vs R2 alone were evaluated in EPCORE® FL-1, a phase 3, open-label, randomized, multicenter, global trial that included patients with R/R FL after at least 1 line of systemic therapy

The dual-primary endpoints were PFS, ORR. Select secondary endpoints were CR, OS, MRD negativity, DOR, DOCR, TTNLT. Key Inclusion Criteria: Patients with relapsed refractory follicular lymphoma after at least 1 line of systemic therapy; histologically confirmed classic follicular lymphoma (Grades 1 to 3A). ECOG PFS 0 to 2.
Dosing schedules for two clinical trial regimens: EPKINLY + R-squared (n=243) and R-squared (n=245). Both are 12-cycle fixed-duration therapies. The EPKINLY + R-squared arm includes subcutaneous EPKINLY, IV rituximab, and oral lenalidomide. The R-squared arm includes IV rituximab and oral lenalidomide. The chart specifies administration timing for each medication within the cycles.

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

†Or <50 x 10⁹/L if bone marrow infiltration by lymphoma or splenomegaly.

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

†Or <50 x 10⁹/L if bone marrow infiltration by lymphoma or splenomegaly.

EPKINLY + R2 was evaluated in a range of patients with indolent to high-risk disease characteristics1,3

EPCORE® FL-1 included patients with 2L+ FL across a spectrum of characteristics, ranging from those whose disease progressed within 24 months to those who had a longer response

Tables comparing baseline demographics and prior treatment history for patients in the EPKINLY + R-squared (n=243) and R-squared (n=245) clinical trial arms. The demographics table includes data on age, disease stage, and performance status. The treatment history table covers prior lines of therapy, refractory status, and other treatment-related metrics.

2L=second line; 3L=third line; ALT=alanine aminotransferase; ANC=absolute neutrophil count; AST=aspartate aminotransferase; CD20=cluster of differentiation 20; CNS=central nervous system; CR=complete response; CV=cardiovascular; 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; IRC=Independent Review Committee; IV=intravenous; MRD=minimal residual disease; ORR=overall response rate; OS=overall survival; POD24=progression of disease over 24 months; R2=rituximab + lenalidomide; PR=partial response; R/R=relapsed/refractory; SCT=stem cell transplant; TTNLT=time to next antilymphoma treatment; ULN=upper limit of normal.

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

SEE THE CLINICAL TRIAL RESULTS