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EPCORE FL-1

Epcoritamab, lenalidomide, and rituximab versus lenalidomide and rituximab for relapsed or refractory follicular lymphoma (EPCORE FL-1): a global, open-label, randomised, phase 3 trial

Phase 3N = 488NCT05409066

Population
Relapsed or refractory follicular lymphoma after at least one previous line of chemoimmunotherapy; 243 allocated to epcoritamab plus R2 and 245 to R2.
Design
Multicountry, open-label phase 3 trial (189 centres, 30 countries): participants with relapsed or refractory follicular lymphoma after at least one previous line of chemoimmunotherapy were randomly allocated 1:1 to fixed-duration epcoritamab plus lenalidomide and rituximab (R2) or R2 alone, for up to 12 cycles. Dual primary endpoints: overall response rate and progression-free survival by independent review committee. Planned interim analysis after 78% of progression-free survival events. 488 participants were randomised.
Primary endpoint
ORR, PFS
Arms
  • R2 (control, n = 245): Lenalidomide (cycles 1-12, days 1-21) plus rituximab (weekly in cycle 1, monthly in cycles 2-5), up to 12 cycles
  • Epcoritamab plus R2 (experimental, n = 243): Epcoritamab (weekly in cycles 1-3, every 4 weeks in cycles 4-12) plus R2, up to 12 cycles
People
Falchi L
PFSHR 0.21 (95% CI 0.14–0.31)Δ 16-month PFS+45.3 pointsΔ ORR+16 points
Show the numbers
Results reported for EPCORE FL-1
EndpointAnalysisEpcoritamab plus R2R2Effect
PFSRandomised participants (243 and 245); population label not stated in the abstractProgression-free survival by independent review committee.interimmedian follow-up 14.8 monthsFalchi 202685.5% at 16 mo40.2% at 16 moHR 0.21 (95% CI 0.14–0.31)P<0.0001Planned interim analysis; estimated 16-month PFS.
ORRRandomised participants (243 and 245); population label not stated in the abstractinterimmedian follow-up 14.8 monthsFalchi 202695% (92–97%)79% (74–84%)P<0.0001Independent review committee; planned interim analysis.
Results reported for EPCORE FL-1
EndpointAnalysisEpcoritamab plus R2R2Effect
PFSRandomised participants (243 and 245); population label not stated in the abstractProgression-free survival by independent review committee.interimmedian follow-up 14.8 monthsFalchi 202685.5% at 16 mo40.2% at 16 moHR 0.21 (95% CI 0.14–0.31)P<0.0001Planned interim analysis; estimated 16-month PFS.
ORRRandomised participants (243 and 245); population label not stated in the abstractinterimmedian follow-up 14.8 monthsFalchi 202695% (92–97%)79% (74–84%)P<0.0001Independent review committee; planned interim analysis.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
PFS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
PFS0.210.14–0.31
Primary publication: Falchi L, Nijland M, Huang H, Linton KM, Seymour JF, Tao R, et al. Epcoritamab, lenalidomide, and rituximab versus lenalidomide and rituximab for relapsed or refractory follicular lymphoma (EPCORE FL-1): a global, open-label, randomised, phase 3 trial. Lancet. 2026;407(10524):161-173. PubMedDOI

Appears in

Sources

  1. Falchi L, Nijland M, Huang H, Linton KM, Seymour JF, Tao R, et al. Epcoritamab, lenalidomide, and rituximab versus lenalidomide and rituximab for relapsed or refractory follicular lymphoma (EPCORE FL-1): a global, open-label, randomised, phase 3 trial. Lancet. 2026;407(10524):161-173.

    PubMedDOI