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New Trial Shows Major Survival Gains with Epcoritamab Added to Standard R2 Therapy
FDA approved epcoritamab plus rituximab and lenalidomide for relapsed follicular lymphoma after trial showed 79% reduction in risk of progression or death compared to standard treatment.
- Recently, the U.S. Food and Drug Administration approved EPKINLY plus rituximab and lenalidomide for relapsed or refractory follicular lymphoma based on EPCORE FL-1 data published in The Lancet.
- The Phase 3 EPCORE FL-1 trial showed epcoritamab+R2 met dual primary endpoints with a 79% risk reduction assessed by the Independent Review Committee using Lugano 2014 criteria recently.
- The study randomized 488 patients, allocating 243 to epcoritamab+R2 and 245 to R2 alone, with EPKINLY dosed in 28-day cycles for up to 12 cycles and higher complete response rates for epcoritamab+R2.
- Clinical implications include epcoritamab plus R2 as the first bispecific antibody‑based, chemotherapy‑free combo with superior Phase 3 benefit, with 92.8% free from new treatments at 16 months, while Genmab and AbbVie pursue regulatory submissions and commercialization plans.
- Safety data show participants receiving epcoritamab+R2 faced higher grade 3–4 treatment‑emergent adverse events and discontinuations, but the three step‑up dosing regimen kept CRS rate 26.3%.
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New trial shows major survival gains with epcoritamab added to standard R2 therapy
In a new trial, patients with follicular lymphoma had a significantly higher response to treatment and a nearly 80% reduction in the risk of death or disease progression if they received epcoritamab in addition to the standard second-line regimen versus the standard regimen alone.
·United States
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The Daily News+4 Reposted by 4 other sources
Genmab Presents Pivotal Phase 3 Data from EPCORE® FL-1 Trial Demonstrating Clinical Benefit of EPKINLY® (epcoritamab-bysp) in Combination with Rituximab and Lenalidomide (R2) in Patients with Relapsed or Refractory Follicular Lymphoma
COPENHAGEN, Denmark--(BUSINESS WIRE)--Dec 7, 2025-
targetedonc.comReposted by 
oncnursingnews.com
oncnursingnews.comEpcoritamab/R2 Slashes Risk of FL Progression by 79% | Targeted Oncology - Immunotherapy, Biomarkers, and Cancer Pathways
Epcoritamab combined with rituximab and lenalidomide shows remarkable efficacy in treating relapsed follicular lymphoma, setting a new standard of care.
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Leaning Left1Leaning Right0Center3Last UpdatedBias Distribution75% Center
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L 25%
C 75%
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