Genmab: Epcoritamab plus R2 shows consistent benefit across EPCORE FL‑1 subgroups
- Phase 3 EPCORE FL‑1 randomized 481 patients (243 epcoritamab+R2; 238 R2 alone).
- Progression‑free survival favored epcoritamab+R2 with HRs <0.3 across subgroups (e.g. FLIPI 0–2 HR 0.18; FLIPI 3–5 HR 0.25; POD24 HR 0.22).
- Overall and complete response rates were higher with the combination (FLIPI 0–2 ORR 96.5% vs 84.8%; CRR 86.6% vs 62.1%; FLIPI 3–5 ORR 93.0% vs 72.6%; CRR 77.0% vs 35.4%).
- Safety was described as manageable and consistent across subgroups with no new signals; neutropenia and infections were more frequent among patients receiving lower lenalidomide doses.
Trial and analysis
The Phase 3 EPCORE FL‑1 trial randomized 481 relapsed/refractory follicular lymphoma patients to epcoritamab plus rituximab and lenalidomide (R2) (n=243) or R2 alone (n=238). Genmab reported a post‑hoc subgroup analysis presented at EHA 2026 assessing efficacy and tolerability across clinically relevant subgroups including FLIPI (0–2 vs 3–5), POD24 status, and NHL‑5 fitness categories.
Efficacy findings
Progression‑free survival consistently favored epcoritamab+R2, with hazard ratios below 0.3 across analyzed subgroups (FLIPI 0–2 HR 0.18 [0.10–0.33]; FLIPI 3–5 HR 0.25 [0.15–0.42]; POD24 HR 0.22 [0.13–0.37]; NHL‑5 low HR 0.27 [0.17–0.42]; NHL‑5 H+I HR 0.14 [0.06–0.29]). Overall response rates and complete response rates were higher with the combination across risk and fitness categories (examples: FLIPI 0–2 ORR 96.5% vs 84.8%, CRR 86.6% vs 62.1%; FLIPI 3–5 ORR 93.0% vs 72.6%, CRR 77.0% vs 35.4%).
Safety and dosing notes
The safety profile for epcoritamab+R2 was described as manageable and consistent with the overall trial; no new safety signals were identified. The company noted neutropenia and infections were more frequent among patients receiving lower lenalidomide doses and that lenalidomide dose reductions were used in practice to manage adverse events while maintaining benefit.
Source: Genmab
