Trial reportClinical pharmacology and therapeutics2026
Epcoritamab Step-Up Dosing Regimen Selection and Optimization Using Repeated Time-to-Event Modeling for Cytokine Release Syndrome Risk Mitigation.
Trial report in Clinical pharmacology and therapeutics, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Not yet cited in PubMed.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase 1/2, Open-label Safety Trial of GEN3013 in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma
Safety and Preliminary Efficacy of Epcoritamab (GEN3013; DuoBody®-CD3×CD20) in Japanese Subjects With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma - A Phase 1/2, Open-Label, Dose-Escalation Trial With Expansion Cohorts
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14 authors.
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Abstract
Epcoritamab is a CD3 × CD20 T-cell-engaging bispecific antibody approved for the treatment of various types of relapsed/refractory (R/R) large B-cell lymphoma (LBCL) and R/R follicular lymphoma (FL), after at least two lines of systemic therapy. Here, we develop and calibrate repeated time-to-event models to assess the impact of optimized step-up dosing (SUD) regimens and the effect of intravenous fluids and/or corticosteroids on cytokine release syndrome (CRS) risk. The analysis used pooled data from 600 patients with aggressive non-Hodgkin lymphoma (aNHL) and indolent NHL (iNHL) who received subcutaneous epcoritamab in 28-day cycles in the EPCORE® NHL-1 and EPCORE® NHL-3 studies (NCT03625037, NCT04542824). In the calibrated model, prior CAR T cell therapy (125/600 patients [20.8%]) was associated with a 69.7% reduction (95% confidence interval [CI], 38.2-85.2) in the maximum stimulatory effect of epcoritamab on the hazard of Grade ≥2 CRS. Intravenous fluids or dexamethasone during Cycle (C)1 were associated with a 2.89-fold (95% CI, 1.57-5.30) increase in the half-maximal effective plasma concentration of epcoritamab on stimulation (S50). Furthermore, prophylaxis with intravenous fluids and dexamethasone during C1 was associated with a 3.79-fold (95% CI, 1.65-8.73) increase in S50. Simulations show that the use of dexamethasone further reduces Grade ≥2 CRS risk compared with prednisone in patients with aNHL/iNHL. Moreover, a 3-SUD design further reduces CRS risk in patients with iNHL. Overall, our models showed that the approved 2-SUD regimen for R/R LBCL and 3-SUD regimen for R/R FL-together with intravenous fluids and dexamethasone prophylaxis-are adequate to reduce Grade ≥2 CRS risk.
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