Slide 1: Clinically Relevant Subgroup Analysis From the Randomized Phase 3 EPCORE FL-1 Trial
S229 Clinically Relevant Subgroup Analysis From the Randomized Phase 3 EPCORE FL-1 Trial: Treatment Effect of Epcoritamab With Lenalidomide and Rituximab in R/R Follicular Lymphoma Marcel Nijland,1 Lorenzo Falchi,2 Kim Linton,3 Neta Goldschmidt,4 Benoit Tessoulin,5* David Belada,6 Shuo Ma,7 Jayr Sch
Slide 2: Introduction
Introduction • Chemoimmunotherapy or R2 are standard of care options for R/R FL; however, an unmet need for novel treatments with improved outcomes remains1 • Epcoritamab, a subcutaneous CD3×CD20 bispecific antibody, is approved in the US, Brazil, and China and received a positive CHMP opinion in th
Slide 3: EPCORE FL-1: Phase 3, Global, Randomized, Open-Label Study
EPCORE FL-1: Phase 3, Global, Randomized, Open-Label Study1 Fixed-Duration: 12 Cycles (28-Day Cycles) Post Hoc Subgroup Analyses Key eligibility criteria Epcoritamab (48 mg) plus R2 Randomization 1:1 • Histologically confirmed • Epcoritamab CD20+ R/R FL 3-SUD cycle 1,a QW; cycles 2–3, QW; cycles 4–1
Slide 4: Epcoritamab + R2 Resulted in Superior Responses and PFS Compared With R2 Alone in the Overall ITT Population
Epcoritamab + R2 Resulted in Superior Responses and PFS Compared With R2 Alone in the Overall ITT Population Overall ITT HR (95% CI) 0.21 (0.14–0.31) The data were previously published (Falchi et al. Lancet. 2026;407:161-173) and reproduced with permission under the terms of the CC BY 4.0 license 4
Slide 5: Efficacy Benefit With Epcoritamab + R2 Was Maintained Across Patient Age Subgroups
Efficacy Benefit With Epcoritamab + R2 Was Maintained Across Patient Age Subgroups Age <70 y HR (95% CI) 0.19 (0.12–0.31) 5 CRR, complete response rate; E, epcoritamab; HR, hazard ratio; ORR, overall response rate; PFS, progression-free survival; R2, lenalidomide and rituximab. EHA 2026
Slide 6: Efficacy Benefit With Epcoritamab + R2 Was Maintained Across Patient Age Subgroups
Efficacy Benefit With Epcoritamab + R2 Was Maintained Across Patient Age Subgroups Age <70 y Age ≥70 y HR (95% CI) 0.19 (0.12–0.31) 0.29 (0.14–0.60) 6 CRR, complete response rate; E, epcoritamab; HR, hazard ratio; ORR, overall response rate; PFS, progression-free survival; R2, lenalidomide and ritux
Slide 7: Regardless of Comorbidity Burden Epcoritamab + R2 Resulted in Higher Response Rates and Improved PFS
Regardless of Comorbidity Burden Epcoritamab + R2 Resulted in Higher Response Rates and Improved PFS NHL-5 Low HR (95% CI) 0.27 (0.17–0.42) • The NHL-5 comorbidity scorea is a five-category score that classifies patients as low, intermediate, or high risk based on vascular disease, congestive heart
Slide 8: Regardless of Comorbidity Burden Epcoritamab + R2 Resulted in Higher Response Rates and Improved PFS
Regardless of Comorbidity Burden Epcoritamab + R2 Resulted in Higher Response Rates and Improved PFS NHL-5 Low NHL-5 H + I HR (95% CI) 0.27 (0.17–0.42) 0.14 (0.06–0.29) • The NHL-5 comorbidity scorea is a five-category score that classifies patients as low, intermediate, or high risk based on vascul
Slide 9: Epcoritamab + R2 Showed Favorable Efficacy Over R2 Across Prior LOT Subgroups
Epcoritamab + R2 Showed Favorable Efficacy Over R2 Across Prior LOT Subgroups 1 Prior LOT HR (95% CI) 0.20 (0.12–0.34) 9 CRR, complete response rate; E, epcoritamab; HR, hazard ratio; LOT, line of therapy; ORR, overall response rate; PFS, progression-free survival; R2, lenalidomide and rituximab. EH
Slide 10: Epcoritamab + R2 Showed Favorable Efficacy Over R2 Across Prior LOT Subgroups
Epcoritamab + R2 Showed Favorable Efficacy Over R2 Across Prior LOT Subgroups 1 Prior LOT ≥2 Prior LOTs HR (95% CI) 0.20 (0.12–0.34) 0.24 (0.13–0.42) 10 CRR, complete response rate; E, epcoritamab; HR, hazard ratio; LOT, line of therapy; ORR, overall response rate; PFS, progression-free survival; R2
Slide 11: Baseline FLIPI Score or POD24 Status Did Not Influence the Treatment Benefit of Epcoritamab + R2
Baseline FLIPI Score or POD24 Status Did Not Influence the Treatment Benefit of Epcoritamab + R2 Over R2 FLIPI 0–2 FLIPI 3–5 No POD24 POD24 HR (95% CI) 0.18 (0.10–0.33) 0.25 (0.15–0.42) HR (95% CI) 0.17 (0.09–0.32) 0.22 (0.13–0.37) CRR, complete response rate; E, epcoritamab; FLIPI, Follicular Lymph
Slide 12: Epcoritamab + R2 Resulted in Higher Response Rates and Improved PFS Over R2 Regardless of Bulky Disease or DR Status
Epcoritamab + R2 Resulted in Higher Response Rates and Improved PFS Over R2 Regardless of Bulky Disease or Double Refractory Status Non-Bulky Disease Bulky Diseasea Not DR DR HR (95% CI) 0.26 (0.17–0.41) 0.12 (0.05–0.28) HR (95% CI) 0.19 (0.11–0.34) 0.23 (0.13–0.39) aBulky disease was defined by the
Slide 13: Both Low- and High-Risk Clinically Relevant Subgroups Showed Improved PFS With Epcoritamab + R2
Both Low- and High-Risk Clinically Relevant Subgroups Showed Improved PFS With Epcoritamab + R2 Over R2 PFS HRs were determined by unstratified Cox proportional hazards model. aBulky disease was defined by the presence of a lymph node ≥7 cm at baseline/screening. FLIPI, Follicular Lymphoma Internati
Slide 14: PFS Favored Epcoritamab + R2 Compared With R2 Alone Regardless of Len RDI Levels
PFS Favored Epcoritamab + R2 Compared With R2 Alone Regardless of Len RDI Levels HR (95% CI) Len RDI ≤70% 0.25 (0.15–0.41) Len RDI >70% 0.13 (0.06–0.25) Overall ITT 0.21 (0.14–0.31) • Len RDI reflects actual Len received as a percentage of planned dose of 12 cycles • Epcoritamab + R2 continued to pr
Slide 15: PFS Favored Epcoritamab + R2 Compared With R2 Alone Regardless of Len RDI Levels
PFS Favored Epcoritamab + R2 Compared With R2 Alone Regardless of Len RDI Levels HR (95% CI) Len RDI <50% 0.28 (0.15–0.51) Len RDI ≤70% 0.25 (0.15–0.41) Len RDI >70% 0.13 (0.06–0.25) Overall ITT 0.21 (0.14–0.31) • Len RDI reflects actual Len received as a percentage of planned dose of 12 cycles • Ep
Slide 16: Epcoritamab + R2 Safety Profile Was Generally Manageable Across Age Subgroups
Epcoritamab + R2 Safety Profile Was Generally Manageable Across Age Subgroups aTEAE leading to discontinuation of any study drug. 16 R2, lenalidomide and rituximab; TEAE, treatment-emergent adverse event. EHA 2026
Slide 17: Safety Profile Remained Generally Manageable Even in Patients With Increased Comorbidity Burden
The Epcoritamab + R2 Safety Profile Remained Generally Manageable Even in Patients With Increased Comorbidity Burdena aComorbidity burden was based on the NHL-5 comorbidity score (Gordon MJ, et al. JCO Clin Cancer Inform. 2024;8:e2300223). bTEAE leading to discontinuation of any study drug. 17 H + I
Slide 18: Conclusions
Conclusions • Fixed-duration epcoritamab + R2 was superior to R2 in the Phase 3 EPCORE FL-1 study in patients with 2L+ FL – There was a 79% reduction in the risk of disease progression or death – Higher rates and durable, deep responses were observed, with improved CRR (83% for epcoritamab + R2 vs 5
Slide 19: Disclosures
Disclosures • M Nijland: received research funding from Takeda and consulting fees from AbbVie. All payments to institution. • L Falchi: received research funding from Roche, Genentech, Genmab, AbbVie, Innate Pharma, BeOne, and AstraZeneca; consultancy fees from Roche, Genentech, Genmab, AbbVie, San
Slide 20: Acknowledgments
Acknowledgments On behalf of all the authors, AbbVie and Genmab would like to thank the patients participating in this clinical trial and their families, and all the study investigators, coordinators, and support staff. The authors thank JP Mei for their assistance with preparing this presentation.