A Phase 3, Multicenter, Randomized, Open-Label Trial to Evaluate the Safety and Efficacy of Epcoritamab + Rituximab and Lenalidomide (R2) compared to Chemoimmunotherapy in Previously Untreated Follicular Lymphoma (EPCORE™FL-2)

The primary objective of the study is to demonstrate that epcoritamab
with R2 (ER2) will improve CR30 rates compared to chemoimmunotherapy
(CIT) in subjects with previously untreated FL. The primary endpoint is the CR30 in Arm A (ER2) versus Arm B (CIT), as determined by PET-CT per Lugano 2014 criteria, as assessed by IRC. Secondary objectives of this study are to compare, between treatment arms (where applicable), the following: Key Secondary Endpoints in Arm A versus Arm B: PFS: time from the date of randomization to the date of disease progression determined by Lugano 2014 criteria per IRC, or
death, whichever occurs first. OS PROs: Maintenance of PF scale of the EORTC QLQ-C30 at Week 25. MRD negativity.