Genmab: EPCORE DLBCL-4 shows PFS benefit for epcoritamab plus lenalidomide
- Phase 3 EPCORE DLBCL-4 met its primary endpoint, showing a statistically significant improvement in progression‑free survival versus R‑GemOx.
- Risk of progression or death reduced by 60% (HR 0.40; 95% CI 0.30–0.55; p<0.0001) using US censoring rules and by 56% (HR 0.44; 95% CI 0.33–0.60; p<0.0001) using non‑US rules.
- The regimen tested was fixed‑duration subcutaneous epcoritamab (DuoBody‑CD3xCD20) plus lenalidomide against standard chemoimmunotherapy R‑GemOx in adults with R/R LBCL who had ≥1 prior systemic therapy (trial NCT06508658).
- Genmab and AbbVie will engage global regulators and plan a future medical‑meeting presentation; the trial started 13 Aug 2024 and is ongoing.
Topline efficacy
Topline results from the Phase 3 EPCORE DLBCL-4 trial show the fixed‑duration combination of subcutaneous epcoritamab and lenalidomide achieved a statistically significant and clinically meaningful improvement in progression‑free survival compared with rituximab plus gemcitabine plus oxaliplatin (R‑GemOx). The risk of disease progression or death was reduced by 60% (HR 0.40; 95% CI 0.30–0.55; p<0.0001) using U.S. censoring rules and by 56% (HR 0.44; 95% CI 0.33–0.60; p<0.0001) using non‑U.S. rules. Safety of the combination was consistent with previously reported profiles of the individual agents.
Trial design and population
EPCORE DLBCL-4 is a global, open‑label, randomized Phase 3 trial comparing fixed‑duration epcoritamab (GEN3013, DuoBody‑CD3xCD20) plus lenalidomide to R‑GemOx in adult patients with relapsed or refractory large B‑cell lymphoma (including DLBCL NOS, HGBL with MYC/BCL2 and/or BCL6 rearrangements, FL3B, T‑cell/histiocyte‑rich LBCL, and EBV+ DLBCL). Eligible patients had received at least one prior systemic antineoplastic therapy including an anti‑CD20 antibody, and had failed/relapsed after or were not candidates for autologous stem cell transplant and were ineligible for or unable to receive CAR‑T therapy. The trial started on 13 August 2024 and is ongoing (NCT06508658).
Regulatory and next steps
Genmab and AbbVie will engage global regulatory authorities regarding the topline data. Full data will be prepared for submission to a future medical meeting.
Source: Genmab
