Title: A Phase 3 Trial of Epcoritamab in R/R DLBCL
Principal Investigator: To be announced
Data from a phase 1/2 trial of the subcutaneously administered bispecific antibody epcoritamab supported further study of the novel therapy,1 prompting the launch of a phase 3 trial (NCT04628494) in which investigators will compare epcoritamab with investigator’s choice of chemotherapy in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).2 The study is specifically recruiting 480 patients who previously received a minimum of 1 line of systemic antineoplastic therapy, including an anti-CD20 monoclonal antibody-containing combination chemotherapy.
Patients with histologically confirmed CD20-positive DLBCL must have disease that meets one of the following criteria:
- Is de novo or histologically transformed (including Richter’s transformation)
- Meets classifications for “double-hit” or “triple-hit” disease
- Is grade 3b follicular lymphoma
Individuals seeking to enroll on the study need also to demonstrate an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2, failure of prior high-dose therapy-autologous stem cell transplantat (HDT-ASCT) or ineligibility for HDT-ASCT; and acceptable renal and liver function.
Individuals who have a central nervous system (CNS) tumor or known CNS involvement will be excluded. Exclusion will also apply to those who have received prior therapy with a CD20- or CD3-targeted bispecific antibody. Additional exclusion criteria are available on the trial’s registry page on ClinicalTrials.gov.
Investigators will randomly assign participants (1:1) to receive either epcoritamab or 1 of 2 combination chemotherapy regimens: rituximab plus gemcitabine and oxaliplatin (R-GemOx) or bendamustine and rituximab (BR). Epcoritamab and R-GemOX will be respectively administered in 28-day cycles until disease progression; BR will be given in 21-day cycles.
The primary end point is overall survival. Secondary end points include progression-free survival, overall response rate, complete response, duration of response, time to response, and time to next anti-lymphoma therapy.
- Hutchings M, Mous R, Clausen MR, et al. Subcutaneous epcoritamab induces complete responses with an encouraging safety profile across relapsed/refractory B-cell non-Hodgkin lymphoma subtypes, including patients with prior CAR-T therapy: updated dose escalation data. Blood. 2020;136(Suppl 1):45-46. doi:10.1182/blood-2020-133820
- ClinicalTrials.gov. A Phase 3 Trial of Epcoritamab in R/R DLBCL. NCT04628494. Accessed February 19, 2021. https://www.clinicaltrials.gov/ct2/show/NCT04628494?term=Epcoritamab&draw=2&rank=1