A Phase 3 Trial of Epcoritamab vs Investigator's Choice Chemotherapy in R/R DLBCL

Main Inclusion Criteria:

Relapsed or refractory disease and previously treated with at least 1 line of systemic antineoplastic therapy including anti-CD20 mAb-containing combination chemotherapy since lymphoma diagnosis

One of the confirmed histologies below with CD20-positivity:

1. DLBCL, NOS, including de novo or histologically transformed from FL
2. "Double-hit" or "triple-hit" DLBCL (technically classified in WHO 2016 as HGBCL, with MYC and BCL2 and/or BCL6 translocations), including de novo or histologically transformed from FL
3. FL Grade 3B
4. T-cell/histiocyte-rich large B-cell lymphoma
5. ECOG PS score of 0-2
6. Failed previous HDT-ASCT or not eligible for HDT-ASCT at screening
7. Patients must have detectable disease by PET scan and measurable by CT scan or MRI
8. Acceptable renal and liver function
9. Life expectancy >2 months on SOC treatment

Main Exclusion Criteria:

1. Primary Central Nervous System (CNS) tumor or known CNS involvement
2. Any prior therapy with a bispecific antibody targeting CD3 and CD20
3. Major surgery within 4 weeks prior to randomization
4. Chemotherapy and other non-investigational antineoplastic agents (except CD20 mAbs) within 4 weeks or 5 half-lives (whichever is shorter) prior to randomization
5. Any investigational drug within 4 weeks or 5 half-lives, whichever is longer, prior to randomization
6. ASCT within 100 days of randomization
7. Treatment with CAR-T therapy within 100 days prior to randomization
8. Seizure disorder requiring anti-epileptic therapy
9. Clinically significant cardiac disease