Genmab: Epcoritamab shows high response rates in elderly first‑line DLBCL with mono and R‑mini‑CHOP regimens
- EPCORE DLBCL‑3 (n=66; median age 82.5) — epcoritamab monotherapy: ORR 67% and CR 58% with median follow‑up 21.9 months.
- EPCORE NHL‑2 Arm 8 (n=28) — epcoritamab + R‑mini‑CHOP: ORR 93%, CR 86%; two‑year estimated PFS 76% and OS 82%.
- High MRD negativity: 92% of evaluable responders in DLBCL‑3 and 95% in NHL‑2 Arm 8, typically achieved by Cycle 3 Day 1 and sustained through Cycle 12 Day 1 in most patients.
- Key safety signals: CRS in 71% (mostly Cycle 1), ICANS 18%; in combination arm Grade ≥3 neutropenia 54% and serious infections 33%; three patients (11%) discontinued epcoritamab due to TEAEs.
Trial populations and design
Two investigator‑led cohorts evaluated subcutaneous epcoritamab in elderly, newly diagnosed CD20+ DLBCL patients ineligible for standard anthracycline regimens. EPCORE DLBCL‑3 (Phase 2) enrolled 66 patients (median age 82.5; 94% with ≥3 comorbidities) for fixed‑duration monotherapy. EPCORE NHL‑2 Arm 8 (Phase 1b/2) enrolled 28 patients for fixed‑duration epcoritamab combined with R‑mini‑CHOP; follow‑up exceeded two years.
Efficacy outcomes
In DLBCL‑3 evaluable patients, overall response rate (ORR) was 67% and complete response (CR) rate 58%; median time to response 1.5 months and to CR 2.2 months. Median duration of response (DOR) and duration of CR (DOCR) were not reached; at 12 months ~67% of responses and 73% of CRs remained ongoing. Median progression‑free survival (PFS) was 13.0 months and median overall survival (OS) was not reached. In NHL‑2 Arm 8, ORR was 93% and CR 86%; median DOR, DOCR, PFS and OS were not reached and two‑year estimated DOR/DOCR were 79%, PFS 76% and OS 82%.
MRD and safety
High rates of minimal residual disease (MRD) negativity were reported: 92% of evaluable responders in DLBCL‑3 and 95% in NHL‑2 Arm 8, typically by Cycle 3 Day 1 and sustained through Cycle 12 Day 1 in most patients. Safety profiles were consistent with prior reports: CRS occurred in 71% (mostly in Cycle 1) and ICANS in 18% in DLBCL‑3; infections (any grade) were 68% with 26% Grade ≥3. In the combination arm the most common Grade ≥3 TEAEs were neutropenia (54%), serious infections (33%) and anemia (14%); TEAEs led to epcoritamab discontinuation in three patients (11%).
Context
Results were presented at the 2026 European Hematology Association (EHA) Congress and the full EPCORE DLBCL‑3 dataset has been published in The Lancet Haematology.
Source: Genmab
