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

Percentage of Participants Achieving CR

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 frame: Up to approximately 5 years

Overall Survival (OS)

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

Time frame: Up to approximately 8 years from randomization

Percentage of Participants Achieving Minimal Residual Disease (MRD) Negativity

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

Time frame: Up to approximately 5 years

Change in Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym)

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.

Time frame: Up to approximately 8 years

PFS as Assessed by Investigator

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).

Time frame: Up to approximately 5 years

Percentage of Participants Achieving BOR as Assessed by Investigator

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

Time frame: Up to approximately 5 years

Percentage of Participants Achieving CR as Assessed by 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.

Time frame: Up to approximately 5 years

Duration of Response (DOR)

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

Time frame: Up to approximately 8 years

Duration of Complete Response (DOCR)

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

Time frame: Up to approximately 8 years

Time to Progression (TTP)

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 frame: Up to approximately 8 years

Time to Next Anti-Lymphoma Treatment (TTNLT)

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.

Time frame: Up to approximately 8 years

Percentage of Participants Achieving CR at the End of 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 frame: Up to approximately 5 years

Time to Response (TTR)

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

Time frame: Up to approximately 8 years

Time to Complete Response (TTCR)

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

Time frame: Up to approximately 8 years

Event-Free Survival (EFS)

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).

Time frame: Up to approximately 8 years

Time to next anti-lymphoma treatment (TTNLT)

Time frame: Up to approximately 8 years

Change in Patient's Global Impression of Severity (PGIS)

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.

Time frame: Up to approximately 8 years

Change in Patient's Global Impression of Change (PGIC)

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.

Time frame: Up to approximately 8 years

Change in EuroQol 5-Dimension Questionnaire, 5-level (EQ-5D-5L)

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.

Time frame: Up to approximately 8 years