Study of Subcutaneous Epcoritamab in Combination With Intravenous Rituximab and Oral Lenalidomide (R2) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Follicular Lymphoma

BOR is defined as Complete Response (CR) or Partial Response (PR), determined by Lugano criteria, as assessed by an IRC.

PFS is defined as duration from the date of randomization to the date of disease progression determined by Lugano criteria by independent review committee (IRC) or death (whichever occurs first).

Percentage of participants who achieve a CR determined per Lugano criteria, as assessed by the IRC prior to the initiation of subsequent anti-lymphoma therapy.

Overall survival is defined as the duration from the date of randomization to the date of the participant's death.

MRD negativity rate is defined as the percentage of participants who achieve MRD negative status prior to the initiation of subsequent anti-lymphoma therapy.

The objective of the FACT-Lym patient-reported outcome (PRO) is to address health-related quality of life issues for adult lymphoma patients. It utilizes a 5-point Like-type scale, with a higher score signifying a higher quality of life.

PFS is defined as duration from the date of randomization to the date of disease progression determined by Lugano criteria by investigator or death (whichever occurs first).

BOR is defined as CR PR, determined by Lugano criteria, as assessed by an investigator.

Percentage of participants who achieve a CR determined per Lugano criteria, as assessed by the investigator prior to the initiation of subsequent anti-lymphoma therapy.

DOR is defined as the time from the first occurrence of response (CR or PR) to disease progression or death, whichever occurs first.

DOR is defined as the time from the first occurrence of CR to disease progression or death, whichever occurs first.

Time to progression is defined as the number of days from the date of study drug start to the date of the first documented disease progression or relapse.

Time to next anti-lymphoma treatment is defined as the number of days from the date of the first documented disease progression or relapse to the date of next anti-lymphoma treatment.

Percentage of participants who achieve a CR determined per Lugano criteria, as assessed by the IRC prior to the initiation of subsequent anti-lymphoma therapy.

Time to response is defined for participants achieving a CR/PR as the time from starting therapy to first a CR/PR.

Time to complete response is defined for participants achieving a CR/PR as the time from starting therapy to first a CR/PR.

EFS is defined as the duration from randomization to disease progression determined by Lugano criteria as assessed by the investigator, initiation of any non-protocol-specified new anti-lymphoma therapy for any reason, or death (whichever occurs first).

PGIS is a self-report measure PGIS reflects a participant's belief about their lymphoma symptoms over the past 7 days. The PGIS is a 5-point scale depicting a participant's rating of overall severity. Participants rate their lymphoma symptoms severity as none, mild, moderate, severe, or very severe.

PGIS is a self-report measure PGIC reflects a participant's belief about the efficacy of treatment. The PGIC is a 7-point scale depicting a participant's rating of overall improvement since start of treatment. Participants rate their change as very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse.

The EQ-5D-5L descriptive system measures health status and comprises 5 health aspects including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each parameter has 5 response levels: no problems, slight problems, moderate problems, severe problems, unable to/extreme problems. This instrument will not be administered during the Survival Follow-Up.