Follicular Lymphoma, Marginal Zone Lymphoma
Conditions
Keywords
MOR00208, INCMOR00208, tafasitamab
Brief summary
This is a Phase 3 double-blind, placebo-controlled, randomized study designed to investigate whether tafasitamab and lenalidomide as an add-on to rituximab provides improved clinical benefit compared with lenalidomide as an add-on to rituximab in patients with R/R FL Grade 1 to 3a or R/R MZL.
Interventions
DRUGtafasitamab
tafasitamab will be administered IV for 12 cycles
DRUGrituximab
Rituximab will be administered IV on cycles 1 - 5
DRUGlenalidomide
Lenalidomide will be administered PO for 12 cycles
DRUGplacebo
placebo will be administered IV for 12 cycles
Sponsors
Incyte Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Double Blind
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed Grade 1, 2, or 3a FL or nodal MZL, splenic MZL, or extra nodal MZL * Willingness to avoid pregnancy or fathering children * In the opinion of the investigator, be able and willing to receive adequate mandatory prophylaxis and/or therapy for thromboembolic events (eg, aspirin 70-325 mg daily or low-molecular-weight heparin) * Previously treated with at least 1 prior systemic anti-CD20 immunotherapy or chemo-immunotherapy * Documented relapsed, refractory, or PD after treatment with systemic therapy * ECOG performance status of 0 to 2
Exclusion criteria
* Women who are pregnant or breastfeeding. * Any histology other than FL and MZL or clinical evidence of transformed lymphoma * Prior non-hematologic malignancy * Congestive heart failure * HCV positivity, chronic HBV infection or history of HIV infection * Active systemic infection * CNS lymphoma involvement * Any systemic anti-lymphoma and/or investigational therapy within 28 days prior to the start of Cycle 1 * Prior use of lenalidomide in combination with rituximab
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| FL Population: Progression-free Survival (PFS) by Investigator Assessment, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented Disease Progression (PD), or Death From Any Cause, Whichever Occurred First | up to approximately 34 months | PD, positron emission tomography (PET): score 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) for lymph node/extra lymphatic sites with increase in intensity of Baseline uptake and/or new fluorodeoxyglucose (FDG)-avid foci consistent with lymphoma at interim/end-of-treatment assessment; new/recurrent FDG-avid foci in bone marrow; new FDG-avid foci consistent with lymphoma versus other etiology in new lesions. PD, computed tomography (CT): abnormal individual node/lesion with longest diameter (LDi ) \>1.5 centimeters (cm) and increase by ≥50% from the product of the perpendicular diameters (PPD) nadir and increase in LDi or shortest diameter (SDi) from nadir; new/clear progression of preexisting nontarget lesions; new/recurrent splenomegaly and bone marrow involvement; regrowth of previously resolved lesions. New node \>1.5 cm in any axis. New extranodal site \>1.0 cm in any axis; if \<1.0 cm, presence is unequivocal and attributable to lymphoma. |
| FL Population: Kaplan-Meier Estimates of PFS by Investigator Assessment, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First | up to 2 years | PD, PET: score 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) for lymph node/extra lymphatic sites with increase in intensity of Baseline uptake and/or new FDG-avid foci consistent with lymphoma at interim/end-of-treatment assessment; new/recurrent FDG-avid foci in bone marrow; new FDG-avid foci consistent with lymphoma versus other etiology in new lesions. PD, CT: abnormal individual node/lesion with LDi \>1.5 cm and increase by ≥50% from the PPD nadir and increase in LDi or SDi from nadir; new/clear progression of preexisting nontarget lesions; new/recurrent splenomegaly and bone marrow involvement; regrowth of previously resolved lesions. New node \>1.5 cm in any axis. New extranodal site \>1.0 cm in any axis; if \<1.0 cm, presence is unequivocal and attributable to lymphoma. Kaplan-Meier estimates indicate the percent probability of a participant being alive at the indicated time after treatment start. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Population: PFS by Investigator Assessment, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First | up to approximately 34 months | PD, PET: score 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) for lymph node/extra lymphatic sites with increase in intensity of Baseline uptake and/or new FDG-avid foci consistent with lymphoma at interim/end-of-treatment assessment; new/recurrent FDG-avid foci in bone marrow; new FDG-avid foci consistent with lymphoma versus other etiology in new lesions. PD, CT: abnormal individual node/lesion with LDi \>1.5 cm and increase by ≥50% from the PPD nadir and increase in LDi or SDi from nadir; new/clear progression of preexisting nontarget lesions; new/recurrent splenomegaly and bone marrow involvement; regrowth of previously resolved lesions. New node \>1.5 cm in any axis. New extranodal site \>1.0 cm in any axis; if \<1.0 cm, presence is unequivocal and attributable to lymphoma. |
| Overall Population: Kaplan-Meier Estimates of PFS by Investigator Assessment, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First | up to 2 years | PD, PET: score 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) for lymph node/extra lymphatic sites with increase in intensity of Baseline uptake and/or new FDG-avid foci consistent with lymphoma at interim/end-of-treatment assessment; new/recurrent FDG-avid foci in bone marrow; new FDG-avid foci consistent with lymphoma versus other etiology in new lesions. PD, CT: abnormal individual node/lesion with LDi \>1.5 cm and increase by ≥50% from the PPD nadir and increase in LDi or SDi from nadir; new/clear progression of preexisting nontarget lesions; new/recurrent splenomegaly and bone marrow involvement; regrowth of previously resolved lesions. New node \>1.5 cm in any axis. New extranodal site \>1.0 cm in any axis; if \<1.0 cm, presence is unequivocal and attributable to lymphoma. Kaplan-Meier estimates indicate the percent probability of a participant being alive at the indicated time after treatment start. |
| FDG-avid FL Population: Positron Emission Tomography-Complete Response (PET-CR) Rate by Investigator Assessment, Using the Lugano 2014 Criteria | up to approximately 34 months | CR was defined as a complete metabolic response at any time after the start of treatment. Per PET, CR criteria: (1) score of 1, 2, or 3 with or without a residual mass on a 5-point scale for lymph nodes and extralymphatic sites; (2) No evidence of FDG-avid disease in bone marrow; and (3) no new lesions. PET 5-point scale: 1 = no uptake above background; 2 = uptake ≤ mediastinum; 3 = uptake \> mediastinum but ≤ liver; 4 = uptake moderately \> liver; 5 = uptake markedly higher than liver and/or new lesions; X = new areas of uptake unlikely to be related to lymphoma. |
| FL Population: Overall Survival | up to approximately 34 months | Overall survival was defined as the time from randomization until death from any cause. |
| FL Population: Kaplan-Meier Estimates of Overall Survival | up to 2 years | Overall survival was defined as the time from randomization until death from any cause. Kaplan-Meier estimates indicate the percent probability of a participant being alive at the indicated time after treatment start. |
| FDG-avid Overall Population: PET-CR Rate by Investigator Assessment, Using the Lugano 2014 Criteria | up to approximately 34 months | CR was defined as a complete metabolic response at any time after the start of treatment. Per PET, CR criteria: (1) score of 1, 2, or 3 with or without a residual mass on a 5-point scale for lymph nodes and extralymphatic sites; (2) No evidence of FDG-avid disease in bone marrow; and (3) no new lesions. PET 5-point scale: 1 = no uptake above background; 2 = uptake ≤ mediastinum; 3 = uptake \> mediastinum but ≤ liver; 4 = uptake moderately \> liver; 5 = uptake markedly higher than liver and/or new lesions; X = new areas of uptake unlikely to be related to lymphoma. The Overall FDG-avid Set included all randomized participants with a PET scan at Baseline with a resulting Deauville score of 4 or 5. |
| FL Population: Minimal Residual Disease (MRD)-Negativity Rate (at Threshold of 10^-5) at End of Treatment | up to approximately 34 months | The MRD-negativity rate was defined as the percentage of participants who achieved a negative MRD result in peripheral blood at the End of Treatment. The threshold used for the analysis was 10\^-5 cells. MRD status was only analyzed with a threshold of ≤10\^-5 cells for MRD negativity. |
| Overall Population: MRD-negativity Rate (at Threshold of 10-5) at End of Treatment | up to approximately 34 months | The MRD-negativity rate was defined as the percentage of participants who achieved a negative MRD result in peripheral blood at the End of Treatment. The threshold used for the analysis was 10\^-5 cells. MRD status was only analyzed with a threshold of ≤10\^-5 cells for MRD negativity. The Overall MRD Blood-Evaluable Set included all participants in the Full Analysis Set who received at least 1 dose of study treatment with identifiable clonality in blood samples at Cycle 1 Day 1. |
| Overall Population: Overall Survival | up to approximately 34 months | Overall survival was defined as the time from randomization until death from any cause. |
| Overall Population: Kaplan-Meier Estimates of Overall Survival | up to 2 years | Overall survival was defined as the time from randomization until death from any cause. Kaplan-Meier estimates indicate the percent probability of a participant being alive at the indicated time after treatment start. |
| FL Population: Overall Response Rate (Percentage of Participants Who Achieved a CR/PR Per the Lugano Classification at Any Time During the Study But Before the First PD and Before/at the Start of a New Antilymphoma Treatment) by Investigator Assessment | up to approximately 34 months | PET, CR: (1) score of 1 (no uptake above background), 2 (uptake ≤ mediastinum), or 3 (uptake \> mediastinum but ≤ liver) with/without a residual mass for lymph nodes and extralymphatic sites (LN/ELS); (2) no evidence of FDG-avid disease in bone marrow; (3) no new lesions. PR: (1) score of 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) with reduced uptake compared with Baseline and residual mass(es) of any size for LN/ELS; (2) residual uptake higher than in normal bone marrow but reduced from Baseline; (3) no new lesions. CT, CR: (1) target nodes/nodal masses regressed to ≤1.5 cm in LDi. no extra lymphatic site of disease; (2) absent nontarget lesions; (3) liver/spleen regressed to normal; (4) bone marrow normal by morphology; (5) no new lesions. PR: (1) ≥50% decrease in SPD of up to 6 target measurable nodes and extranodal sites; (2) no increase in target lesions; (3) spleen regressed by \>50% in length beyond normal; (4) no new lesions. |
| Overall Population: Overall Response Rate (Percentage of Participants Who Achieved a CR/PR Per Lugano Classification at Any Time During the Study But Before the First PD and Before/at the Start of a New Antilymphoma Treatment) by Investigator Assessment | up to approximately 34 months | PET, CR: (1) score of 1 (no uptake above background), 2 (uptake ≤ mediastinum), or 3 (uptake \> mediastinum but ≤ liver) with/without a residual mass for lymph nodes and extralymphatic sites (LN/ELS); (2) no evidence of FDG-avid disease in bone marrow; (3) no new lesions. PR: (1) score of 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) with reduced uptake compared with Baseline and residual mass(es) of any size for LN/ELS; (2) residual uptake higher than in normal bone marrow but reduced from Baseline; (3) no new lesions. CT, CR: (1) target nodes/nodal masses regressed to ≤1.5 cm in LDi. no extra lymphatic site of disease; (2) absent nontarget lesions; (3) liver/spleen regressed to normal; (4) bone marrow normal by morphology; (5) no new lesions. PR: (1) ≥50% decrease in SPD of up to 6 target measurable nodes and extranodal sites; (2) no increase in target lesions; (3) spleen regressed by \>50% in length beyond normal; (4) no new lesions. |
| FL Population: Duration of Response (DOR; the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by Investigator Assessment | up to approximately 34 months | PET, CR: (1) score of 1 (no uptake above background), 2 (uptake ≤ mediastinum), or 3 (uptake \> mediastinum but ≤ liver) with/without a residual mass for lymph nodes and extralymphatic sites (LN/ELS); (2) no evidence of FDG-avid disease in bone marrow; (3) no new lesions. PR: (1) score of 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) with reduced uptake compared with Baseline and residual mass(es) of any size for LN/ELS; (2) residual uptake higher than in normal bone marrow but reduced from Baseline; (3) no new lesions. CT, CR: (1) target nodes/nodal masses regressed to ≤1.5 cm in LDi. no extra lymphatic site of disease; (2) absent nontarget lesions; (3) liver/spleen regressed to normal; (4) bone marrow normal by morphology; (5) no new lesions. PR: (1) ≥50% decrease in SPD of up to 6 target measurable nodes and extranodal sites; (2) no increase in target lesions; (3) spleen regressed by \>50% in length beyond normal; (4) no new lesions. |
| FL Population: Kaplan-Meier Estimates of DOR (the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by Investigator Assessment | up to 2 years | PET, CR: (1) score of 1 (no uptake above background), 2 (uptake ≤ mediastinum), or 3 (uptake \> mediastinum but ≤ liver) with/without a residual mass for lymph nodes and extralymphatic sites (LN/ELS); (2) no evidence of FDG-avid disease in bone marrow; (3) no new lesions. PR: (1) score of 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) with reduced uptake compared with Baseline and residual mass(es) of any size for LN/ELS; (2) residual uptake higher than in normal bone marrow but reduced from Baseline; (3) no new lesions. CT, CR: (1) target nodes/nodal masses regressed to ≤1.5 cm in LDi. no extra lymphatic site of disease; (2) absent nontarget lesions; (3) liver/spleen regressed to normal; (4) bone marrow normal by morphology; (5) no new lesions. PR: (1) ≥50% decrease in SPD of up to 6 target measurable nodes and extranodal sites; (2) no increase in target lesions; (3) spleen regressed by \>50% in length beyond normal; (4) no new lesions. |
| Overall Population: DOR (the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by Investigator Assessment | up to approximately 34 months | PET, CR: (1) score of 1 (no uptake above background), 2 (uptake ≤ mediastinum), or 3 (uptake \> mediastinum but ≤ liver) with/without a residual mass for lymph nodes and extralymphatic sites (LN/ELS); (2) no evidence of FDG-avid disease in bone marrow; (3) no new lesions. PR: (1) score of 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) with reduced uptake compared with Baseline and residual mass(es) of any size for LN/ELS; (2) residual uptake higher than in normal bone marrow but reduced from Baseline; (3) no new lesions. CT, CR: (1) target nodes/nodal masses regressed to ≤1.5 cm in LDi. no extra lymphatic site of disease; (2) absent nontarget lesions; (3) liver/spleen regressed to normal; (4) bone marrow normal by morphology; (5) no new lesions. PR: (1) ≥50% decrease in SPD of up to 6 target measurable nodes and extranodal sites; (2) no increase in target lesions; (3) spleen regressed by \>50% in length beyond normal; (4) no new lesions. |
| Overall Population: Kaplan-Meier Estimates of DOR (the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by Investigator Assessment | up to 2 years | PET, CR: (1) score of 1 (no uptake above background), 2 (uptake ≤ mediastinum), or 3 (uptake \> mediastinum but ≤ liver) with/without a residual mass for lymph nodes and extralymphatic sites (LN/ELS); (2) no evidence of FDG-avid disease in bone marrow; (3) no new lesions. PR: (1) score of 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) with reduced uptake compared with Baseline and residual mass(es) of any size for LN/ELS; (2) residual uptake higher than in normal bone marrow but reduced from Baseline; (3) no new lesions. CT, CR: (1) target nodes/nodal masses regressed to ≤1.5 cm in LDi. no extra lymphatic site of disease; (2) absent nontarget lesions; (3) liver/spleen regressed to normal; (4) bone marrow normal by morphology; (5) no new lesions. PR: (1) ≥50% decrease in SPD of up to 6 target measurable nodes and extranodal sites; (2) no increase in target lesions; (3) spleen regressed by \>50% in length beyond normal; (4) no new lesions. |
| FL Population: PFS by IRC Review, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First | up to approximately 34 months | PD, PET: score 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) for lymph node/extra lymphatic sites with increase in intensity of Baseline uptake and/or new FDG-avid foci consistent with lymphoma at interim/end-of-treatment assessment; new/recurrent FDG-avid foci in bone marrow; new FDG-avid foci consistent with lymphoma versus other etiology in new lesions. PD, CT: abnormal individual node/lesion with LDi \>1.5 cm and increase by ≥50% from the PPD nadir and increase in LDi or SDi from nadir; new/clear progression of preexisting nontarget lesions; new/recurrent splenomegaly and bone marrow involvement; regrowth of previously resolved lesions. New node \>1.5 cm in any axis. New extranodal site \>1.0 cm in any axis; if \<1.0 cm, presence is unequivocal and attributable to lymphoma. |
| FL Population: Kaplan-Meier Estimates of PFS by IRC Review, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First | up to 2 years | PD, PET: score 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) for lymph node/extra lymphatic sites with increase in intensity of Baseline uptake and/or new FDG-avid foci consistent with lymphoma at interim/end-of-treatment assessment; new/recurrent FDG-avid foci in bone marrow; new FDG-avid foci consistent with lymphoma versus other etiology in new lesions. PD, CT: abnormal individual node/lesion with LDi \>1.5 cm and increase by ≥50% from the PPD nadir and increase in LDi or SDi from nadir; new/clear progression of preexisting nontarget lesions; new/recurrent splenomegaly and bone marrow involvement; regrowth of previously resolved lesions. New node \>1.5 cm in any axis. New extranodal site \>1.0 cm in any axis; if \<1.0 cm, presence is unequivocal and attributable to lymphoma. Kaplan-Meier estimates indicate the percent probability of a participant being alive at the indicated time after treatment start. |
| Overall Population: PFS by IRC Review, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First | up to approximately 34 months | PD, PET: score 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) for lymph node/extra lymphatic sites with increase in intensity of Baseline uptake and/or new FDG-avid foci consistent with lymphoma at interim/end-of-treatment assessment; new/recurrent FDG-avid foci in bone marrow; new FDG-avid foci consistent with lymphoma versus other etiology in new lesions. PD, CT: abnormal individual node/lesion with LDi \>1.5 cm and increase by ≥50% from the PPD nadir and increase in LDi or SDi from nadir; new/clear progression of preexisting nontarget lesions; new/recurrent splenomegaly and bone marrow involvement; regrowth of previously resolved lesions. New node \>1.5 cm in any axis. New extranodal site \>1.0 cm in any axis; if \<1.0 cm, presence is unequivocal and attributable to lymphoma. |
| Overall Population: Kaplan-Meier Estimates of PFS by IRC Review, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First | up to 2 years | PD, PET: score 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) for lymph node/extra lymphatic sites with increase in intensity of Baseline uptake and/or new FDG-avid foci consistent with lymphoma at interim/end-of-treatment assessment; new/recurrent FDG-avid foci in bone marrow; new FDG-avid foci consistent with lymphoma versus other etiology in new lesions. PD, CT: abnormal individual node/lesion with LDi \>1.5 cm and increase by ≥50% from the PPD nadir and increase in LDi or SDi from nadir; new/clear progression of preexisting nontarget lesions; new/recurrent splenomegaly and bone marrow involvement; regrowth of previously resolved lesions. New node \>1.5 cm in any axis. New extranodal site \>1.0 cm in any axis; if \<1.0 cm, presence is unequivocal and attributable to lymphoma. Kaplan-Meier estimates indicate the percent probability of a participant being alive at the indicated time after treatment start. |
| FL Population: Overall Response Rate (Percentage of Participants Who Achieved a CR/PR Per the Lugano Classification at Any Time During the Study But Before the First PD and Before/at the Start of a New Antilymphoma Treatment) by IRC Review | up to approximately 34 months | PET, CR: (1) score of 1 (no uptake above background), 2 (uptake ≤ mediastinum), or 3 (uptake \> mediastinum but ≤ liver) with/without a residual mass for lymph nodes and extralymphatic sites (LN/ELS); (2) no evidence of FDG-avid disease in bone marrow; (3) no new lesions. PR: (1) score of 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) with reduced uptake compared with Baseline and residual mass(es) of any size for LN/ELS; (2) residual uptake higher than in normal bone marrow but reduced from Baseline; (3) no new lesions. CT, CR: (1) target nodes/nodal masses regressed to ≤1.5 cm in LDi. no extra lymphatic site of disease; (2) absent nontarget lesions; (3) liver/spleen regressed to normal; (4) bone marrow normal by morphology; (5) no new lesions. PR: (1) ≥50% decrease in SPD of up to 6 target measurable nodes and extranodal sites; (2) no increase in target lesions; (3) spleen regressed by \>50% in length beyond normal; (4) no new lesions. |
| Overall Population: Overall Response Rate (Percentage of Participants Who Achieved a CR/PR Per Lugano Classification at Any Time During the Study But Before the First PD and Before/at the Start of a New Antilymphoma Treatment) by IRC Review | up to approximately 34 months | PET, CR: (1) score of 1 (no uptake above background), 2 (uptake ≤ mediastinum), or 3 (uptake \> mediastinum but ≤ liver) with/without a residual mass for lymph nodes and extralymphatic sites (LN/ELS); (2) no evidence of FDG-avid disease in bone marrow; (3) no new lesions. PR: (1) score of 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) with reduced uptake compared with Baseline and residual mass(es) of any size for LN/ELS; (2) residual uptake higher than in normal bone marrow but reduced from Baseline; (3) no new lesions. CT, CR: (1) target nodes/nodal masses regressed to ≤1.5 cm in LDi. no extra lymphatic site of disease; (2) absent nontarget lesions; (3) liver/spleen regressed to normal; (4) bone marrow normal by morphology; (5) no new lesions. PR: (1) ≥50% decrease in SPD of up to 6 target measurable nodes and extranodal sites; (2) no increase in target lesions; (3) spleen regressed by \>50% in length beyond normal; (4) no new lesions. |
| FL Population: Health State EQ-5D-5L Scores at Baseline and End of Treatment | up to approximately 34 months | The EQ-5D-5L contains a participant-reported score regarding health state measured on a visual analog scale (scores range from 0 \[worst imaginable health state\] to 100 \[best imaginable health state\]), and 5 questions on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The 5 questions have 5 response levels: 1, no problems; 2, slight problems; 3, moderate problems; 4, severe problems; and 5, unable to/extreme problems. |
| FL Population: DOR the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by IRC Review | up to approximately 34 months | PET, CR: (1) score of 1 (no uptake above background), 2 (uptake ≤ mediastinum), or 3 (uptake \> mediastinum but ≤ liver) with/without a residual mass for lymph nodes and extralymphatic sites (LN/ELS); (2) no evidence of FDG-avid disease in bone marrow; (3) no new lesions. PR: (1) score of 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) with reduced uptake compared with Baseline and residual mass(es) of any size for LN/ELS; (2) residual uptake higher than in normal bone marrow but reduced from Baseline; (3) no new lesions. CT, CR: (1) target nodes/nodal masses regressed to ≤1.5 cm in LDi. no extra lymphatic site of disease; (2) absent nontarget lesions; (3) liver/spleen regressed to normal; (4) bone marrow normal by morphology; (5) no new lesions. PR: (1) ≥50% decrease in SPD of up to 6 target measurable nodes and extranodal sites; (2) no increase in target lesions; (3) spleen regressed by \>50% in length beyond normal; (4) no new lesions. |
| FL Population: Kaplan-Meier Estimates of DOR (the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by IRC Review | up to 2 years | PET, CR: (1) score of 1 (no uptake above background), 2 (uptake ≤ mediastinum), or 3 (uptake \> mediastinum but ≤ liver) with/without a residual mass for lymph nodes and extralymphatic sites (LN/ELS); (2) no evidence of FDG-avid disease in bone marrow; (3) no new lesions. PR: (1) score of 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) with reduced uptake compared with Baseline and residual mass(es) of any size for LN/ELS; (2) residual uptake higher than in normal bone marrow but reduced from Baseline; (3) no new lesions. CT, CR: (1) target nodes/nodal masses regressed to ≤1.5 cm in LDi. no extra lymphatic site of disease; (2) absent nontarget lesions; (3) liver/spleen regressed to normal; (4) bone marrow normal by morphology; (5) no new lesions. PR: (1) ≥50% decrease in SPD of up to 6 target measurable nodes and extranodal sites; (2) no increase in target lesions; (3) spleen regressed by \>50% in length beyond normal; (4) no new lesions. |
| Overall Population: DOR (the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by IRC Review | up to approximately 34 months | PET, CR: (1) score of 1 (no uptake above background), 2 (uptake ≤ mediastinum), or 3 (uptake \> mediastinum but ≤ liver) with/without a residual mass for lymph nodes and extralymphatic sites (LN/ELS); (2) no evidence of FDG-avid disease in bone marrow; (3) no new lesions. PR: (1) score of 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) with reduced uptake compared with Baseline and residual mass(es) of any size for LN/ELS; (2) residual uptake higher than in normal bone marrow but reduced from Baseline; (3) no new lesions. CT, CR: (1) target nodes/nodal masses regressed to ≤1.5 cm in LDi. no extra lymphatic site of disease; (2) absent nontarget lesions; (3) liver/spleen regressed to normal; (4) bone marrow normal by morphology; (5) no new lesions. PR: (1) ≥50% decrease in SPD of up to 6 target measurable nodes and extranodal sites; (2) no increase in target lesions; (3) spleen regressed by \>50% in length beyond normal; (4) no new lesions. |
| Overall Population: Kaplan-Meier Estimates of DOR (the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by IRC Review | up to 2 years | PET, CR: (1) score of 1 (no uptake above background), 2 (uptake ≤ mediastinum), or 3 (uptake \> mediastinum but ≤ liver) with/without a residual mass for lymph nodes and extralymphatic sites (LN/ELS); (2) no evidence of FDG-avid disease in bone marrow; (3) no new lesions. PR: (1) score of 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) with reduced uptake compared with Baseline and residual mass(es) of any size for LN/ELS; (2) residual uptake higher than in normal bone marrow but reduced from Baseline; (3) no new lesions. CT, CR: (1) target nodes/nodal masses regressed to ≤1.5 cm in LDi. no extra lymphatic site of disease; (2) absent nontarget lesions; (3) liver/spleen regressed to normal; (4) bone marrow normal by morphology; (5) no new lesions. PR: (1) ≥50% decrease in SPD of up to 6 target measurable nodes and extranodal sites; (2) no increase in target lesions; (3) spleen regressed by \>50% in length beyond normal; (4) no new lesions. |
| FL Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | up to approximately 34 months | The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-30 (EORTC QLQ-C30) version 3 is a 30-item scale composed of both multi-item scales and single-item measures. These include 5 functional scales (physical functioning, role, cognitive functioning, emotional functioning, and social functioning), 3 symptom scales (fatigue, pain, and nausea/vomiting), a global health status scale, and 6 single items (constipation, diarrhea, sleep, dyspnea, appetite, financial). All scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Therefore, a high score for a functional scale represents a high/healthy level of functioning and a high score for the global health status/QoL represents a high QoL. A high score for a symptom scale/item represents a high level of symptomatology/problems. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. |
| Overall Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | up to approximately 34 months | The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-30 (EORTC QLQ-C30) version 3 is a 30-item scale composed of both multi-item scales and single-item measures. These include 5 functional scales (physical functioning, role, cognitive functioning, emotional functioning, and social functioning), 3 symptom scales (fatigue, pain, and nausea/vomiting), a global health status scale, and 6 single items (constipation, diarrhea, sleep, dyspnea, appetite, financial). All scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Therefore, a high score for a functional scale represents a high/healthy level of functioning and a high score for the global health status/QoL represents a high QoL. A high score for a symptom scale/item represents a high level of symptomatology/problems. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. |
| Overall Population: Health State EQ-5D-5L Scores at Baseline and End of Treatment | up to approximately 34 months | The EQ-5D-5L contains a participant-reported score regarding health state measured on a visual analog scale (scores range from 0 \[worst imaginable health state\] to 100 \[best imaginable health state\]), and 5 questions on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The 5 questions have 5 response levels: 1, no problems; 2, slight problems; 3, moderate problems; 4, severe problems; and 5, unable to/extreme problems. |
| FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | up to approximately 34 months | The EQ-5D-5L contains a participant-reported score regarding health state measured on a visual analog scale (scores range from 0 \[worst imaginable health state\] to 100 \[best imaginable health state\]), and 5 questions on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The 5 questions have 5 response levels: 1, no problems; 2, slight problems; 3, moderate problems; 4, severe problems; and 5, unable to/extreme problems. |
| Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | up to approximately 34 months | The EQ-5D-5L contains a participant-reported score regarding health state measured on a visual analog scale (scores range from 0 \[worst imaginable health state\] to 100 \[best imaginable health state\]), and 5 questions on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The 5 questions have 5 response levels: 1, no problems; 2, slight problems; 3, moderate problems; 4, severe problems; and 5, unable to/extreme problems. |
| FL Population: Functional Assessment of Cancer Treatment-Lymphoma (FACT-Lym) Scores at Baseline and End of Treatment | up to approximately 34 months | The FACT-Lymphoma (v4) is composed of 42 items with a 5-point Likert-type scale and 5 subscales. Physical well-being (PWB) subscale: 7 items measured on 0- to 4-point scale; total score = 0-28. Social/family well-being (SWB) subscale: 7 items measured on 0- to 4-point scale; total score = 0-28. Emotional well-being (EWB) subscale: 6 items measured on 0- to 4-point scale; total score = 0-24. Functional well-being (FWB) subscale: 7 items measured on 0- to 4-point scale; total score = 0-28. Lymphoma (LymS) subscale includes 15 items; total score = 0-60. Three total scores can be derived by adding the subscales: FACT-Lymphoma Trial Outcome Index (TOI): (PWB score) + (FWB score) + (LymS score); total score = 0-116. FACT-G total score: (PWB score) + (SWB score) + (EWB score) + (FWB score); total score = 0-108. FACT-Lymphoma total score: (PWB score) + (SWB score) + (EWB score) + (FWB score) + (LymS score); total score = 0-168. The higher the score, the better the quality of life. |
| Overall Population: FACT-Lym Scores at Baseline and End of Treatment | up to approximately 34 months | The FACT-Lymphoma (v4) is composed of 42 items with a 5-point Likert-type scale and 5 subscales. Physical well-being (PWB) subscale: 7 items measured on 0- to 4-point scale; total score = 0-28. Social/family well-being (SWB) subscale: 7 items measured on 0- to 4-point scale; total score = 0-28. Emotional well-being (EWB) subscale: 6 items measured on 0- to 4-point scale; total score = 0-24. Functional well-being (FWB) subscale: 7 items measured on 0- to 4-point scale; total score = 0-28. Lymphoma (LymS) subscale includes 15 items; total score = 0-60. Three total scores can be derived by adding the subscales: FACT-Lymphoma Trial Outcome Index (TOI): (PWB score) + (FWB score) + (LymS score); total score = 0-116. FACT-G total score: (PWB score) + (SWB score) + (EWB score) + (FWB score); total score = 0-108. FACT-Lymphoma total score: (PWB score) + (SWB score) + (EWB score) + (FWB score) + (LymS score); total score = 0-168. The higher the score, the better the quality of life. |
Countries
Australia, Austria, Belgium, Canada, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Netherlands, Norway, Poland, Russia, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| FL: Tafasitamab + Rituximab + Lenalidomide Participants with follicular lymphoma (FL) were randomized to receive tafasitamab 12 milligrams per kilogram (mg/kg) intravenously (IV), administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg once daily (QD), administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/meters squared (m\^2) IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days. | 273 |
| MZL: Tafasitamab + Rituximab + Lenalidomide Participants with marginal zone lymphoma (MZL) were randomized to receive tafasitamab 12 mg/kg IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days. | 275 |
| FL: Placebo + Rituximab + Lenalidomide Participants with FL were randomized to receive placebo 0.9% saline solution IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days. | 53 |
| MZL: Placebo + Rituximab + Lenalidomide Participants with MZL were randomized to receive placebo 0.9% saline solution IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days. | 53 |
| Total | 654 |
Baseline characteristics
| Characteristic | FL: Tafasitamab + Rituximab + Lenalidomide | MZL: Tafasitamab + Rituximab + Lenalidomide | FL: Placebo + Rituximab + Lenalidomide | MZL: Placebo + Rituximab + Lenalidomide | Total |
|---|---|---|---|---|---|
| Age, Continuous | 64.6 years STANDARD_DEVIATION 10.89 | 63.7 years STANDARD_DEVIATION 11.69 | 68.3 years STANDARD_DEVIATION 10.69 | 67.9 years STANDARD_DEVIATION 11.4 | 64.8 years STANDARD_DEVIATION 11.33 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 31 Participants | 24 Participants | 4 Participants | 8 Participants | 67 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 228 Participants | 226 Participants | 45 Participants | 41 Participants | 540 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 14 Participants | 25 Participants | 4 Participants | 4 Participants | 47 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian | 40 Participants | 42 Participants | 7 Participants | 6 Participants | 95 Participants |
| Race/Ethnicity, Customized Black or African-American | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Captured as "Other" in Database | 2 Participants | 4 Participants | 0 Participants | 0 Participants | 6 Participants |
| Race/Ethnicity, Customized Not Reported | 11 Participants | 10 Participants | 3 Participants | 4 Participants | 28 Participants |
| Race/Ethnicity, Customized White | 219 Participants | 219 Participants | 43 Participants | 41 Participants | 522 Participants |
| Sex: Female, Male Female | 123 Participants | 126 Participants | 27 Participants | 26 Participants | 302 Participants |
| Sex: Female, Male Male | 150 Participants | 149 Participants | 26 Participants | 27 Participants | 352 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 22 / 327 | 24 / 325 | 46 / 652 |
| other Total, other adverse events | 318 / 327 | 315 / 325 | 633 / 652 |
| serious Total, serious adverse events | 125 / 327 | 110 / 325 | 235 / 652 |
Outcome results
Primary
FL Population: Kaplan-Meier Estimates of PFS by Investigator Assessment, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First
PD, PET: score 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) for lymph node/extra lymphatic sites with increase in intensity of Baseline uptake and/or new FDG-avid foci consistent with lymphoma at interim/end-of-treatment assessment; new/recurrent FDG-avid foci in bone marrow; new FDG-avid foci consistent with lymphoma versus other etiology in new lesions. PD, CT: abnormal individual node/lesion with LDi \>1.5 cm and increase by ≥50% from the PPD nadir and increase in LDi or SDi from nadir; new/clear progression of preexisting nontarget lesions; new/recurrent splenomegaly and bone marrow involvement; regrowth of previously resolved lesions. New node \>1.5 cm in any axis. New extranodal site \>1.0 cm in any axis; if \<1.0 cm, presence is unequivocal and attributable to lymphoma. Kaplan-Meier estimates indicate the percent probability of a participant being alive at the indicated time after treatment start.
Time frame: up to 2 years
Population: FL Full Analysis Set. Censored participants were included in the analysis. The number of participants analyzed for the Kaplan-Meier estimate at each time point refers to the total number of participants in the analysis set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: Kaplan-Meier Estimates of PFS by Investigator Assessment, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First | 6 months | 92.4 percent probability |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: Kaplan-Meier Estimates of PFS by Investigator Assessment, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First | 2 years | 41.7 percent probability |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: Kaplan-Meier Estimates of PFS by Investigator Assessment, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First | 12 months | 79.0 percent probability |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: Kaplan-Meier Estimates of PFS by Investigator Assessment, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First | 18 months | 61.9 percent probability |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: Kaplan-Meier Estimates of PFS by Investigator Assessment, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First | 18 months | 38.5 percent probability |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: Kaplan-Meier Estimates of PFS by Investigator Assessment, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First | 2 years | 31.8 percent probability |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: Kaplan-Meier Estimates of PFS by Investigator Assessment, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First | 6 months | 78.2 percent probability |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: Kaplan-Meier Estimates of PFS by Investigator Assessment, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First | 12 months | 54.0 percent probability |
p-value: <0.000195% CI: [0.324, 0.58]stratified Log Rank
Primary
FL Population: Progression-free Survival (PFS) by Investigator Assessment, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented Disease Progression (PD), or Death From Any Cause, Whichever Occurred First
PD, positron emission tomography (PET): score 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) for lymph node/extra lymphatic sites with increase in intensity of Baseline uptake and/or new fluorodeoxyglucose (FDG)-avid foci consistent with lymphoma at interim/end-of-treatment assessment; new/recurrent FDG-avid foci in bone marrow; new FDG-avid foci consistent with lymphoma versus other etiology in new lesions. PD, computed tomography (CT): abnormal individual node/lesion with longest diameter (LDi ) \>1.5 centimeters (cm) and increase by ≥50% from the product of the perpendicular diameters (PPD) nadir and increase in LDi or shortest diameter (SDi) from nadir; new/clear progression of preexisting nontarget lesions; new/recurrent splenomegaly and bone marrow involvement; regrowth of previously resolved lesions. New node \>1.5 cm in any axis. New extranodal site \>1.0 cm in any axis; if \<1.0 cm, presence is unequivocal and attributable to lymphoma.
Time frame: up to approximately 34 months
Population: Follicular Lymphoma (FL) Full Analysis Set: all randomized participants with FL. The 2-sided 95% confidence intervals were calculated using the method of Brookmeyer and Crowley with log-log transformation. Censored participants were included in the analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: Progression-free Survival (PFS) by Investigator Assessment, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented Disease Progression (PD), or Death From Any Cause, Whichever Occurred First | 22.37 months |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: Progression-free Survival (PFS) by Investigator Assessment, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented Disease Progression (PD), or Death From Any Cause, Whichever Occurred First | 13.93 months |
Secondary
FDG-avid FL Population: Positron Emission Tomography-Complete Response (PET-CR) Rate by Investigator Assessment, Using the Lugano 2014 Criteria
CR was defined as a complete metabolic response at any time after the start of treatment. Per PET, CR criteria: (1) score of 1, 2, or 3 with or without a residual mass on a 5-point scale for lymph nodes and extralymphatic sites; (2) No evidence of FDG-avid disease in bone marrow; and (3) no new lesions. PET 5-point scale: 1 = no uptake above background; 2 = uptake ≤ mediastinum; 3 = uptake \> mediastinum but ≤ liver; 4 = uptake moderately \> liver; 5 = uptake markedly higher than liver and/or new lesions; X = new areas of uptake unlikely to be related to lymphoma.
Time frame: up to approximately 34 months
Population: FL FDG-avid Set: all randomized participants with FL and with a PET scan at Baseline with a resulting Deauville score of 4 or 5. Participants who did not have a post-baseline PET scan were considered to be not assessed, but were included in the analysis. The 95% confidence intervals were calculated using the Clopper-Pearson method.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FL: Tafasitamab + Rituximab + Lenalidomide | FDG-avid FL Population: Positron Emission Tomography-Complete Response (PET-CR) Rate by Investigator Assessment, Using the Lugano 2014 Criteria | 49.4 percentage of participants |
| FL: Placebo + Rituximab + Lenalidomide | FDG-avid FL Population: Positron Emission Tomography-Complete Response (PET-CR) Rate by Investigator Assessment, Using the Lugano 2014 Criteria | 39.8 percentage of participants |
p-value: 0.028695% CI: [1.04, 2.13]stratified Cochran-Mantel-Haenszel
Secondary
FDG-avid Overall Population: PET-CR Rate by Investigator Assessment, Using the Lugano 2014 Criteria
CR was defined as a complete metabolic response at any time after the start of treatment. Per PET, CR criteria: (1) score of 1, 2, or 3 with or without a residual mass on a 5-point scale for lymph nodes and extralymphatic sites; (2) No evidence of FDG-avid disease in bone marrow; and (3) no new lesions. PET 5-point scale: 1 = no uptake above background; 2 = uptake ≤ mediastinum; 3 = uptake \> mediastinum but ≤ liver; 4 = uptake moderately \> liver; 5 = uptake markedly higher than liver and/or new lesions; X = new areas of uptake unlikely to be related to lymphoma. The Overall FDG-avid Set included all randomized participants with a PET scan at Baseline with a resulting Deauville score of 4 or 5.
Time frame: up to approximately 34 months
Population: Overall FDG-avid Set. As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Participants who did not have a post-baseline PET scan were considered to be not assessed, but were included in the analysis. The 95% confidence intervals were calculated using the Clopper-Pearson method.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FL: Tafasitamab + Rituximab + Lenalidomide | FDG-avid Overall Population: PET-CR Rate by Investigator Assessment, Using the Lugano 2014 Criteria | 50.7 percentage of participants |
| FL: Placebo + Rituximab + Lenalidomide | FDG-avid Overall Population: PET-CR Rate by Investigator Assessment, Using the Lugano 2014 Criteria | 41.3 percentage of participants |
p-value: 0.022195% CI: [1.06, 2.03]stratified Cochran-Mantel-Haenszel
Secondary
FL Population: DOR the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by IRC Review
PET, CR: (1) score of 1 (no uptake above background), 2 (uptake ≤ mediastinum), or 3 (uptake \> mediastinum but ≤ liver) with/without a residual mass for lymph nodes and extralymphatic sites (LN/ELS); (2) no evidence of FDG-avid disease in bone marrow; (3) no new lesions. PR: (1) score of 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) with reduced uptake compared with Baseline and residual mass(es) of any size for LN/ELS; (2) residual uptake higher than in normal bone marrow but reduced from Baseline; (3) no new lesions. CT, CR: (1) target nodes/nodal masses regressed to ≤1.5 cm in LDi. no extra lymphatic site of disease; (2) absent nontarget lesions; (3) liver/spleen regressed to normal; (4) bone marrow normal by morphology; (5) no new lesions. PR: (1) ≥50% decrease in SPD of up to 6 target measurable nodes and extranodal sites; (2) no increase in target lesions; (3) spleen regressed by \>50% in length beyond normal; (4) no new lesions.
Time frame: up to approximately 34 months
Population: FL Full Analysis Set. The 2-sided 95% confidence intervals were calculated using the method of Brookmeyer and Crowley with log-log transformation. Only those participants who achieved an objective response (CR or PR) were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: DOR the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by IRC Review | NA months |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: DOR the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by IRC Review | 18.23 months |
Secondary
FL Population: Duration of Response (DOR; the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by Investigator Assessment
PET, CR: (1) score of 1 (no uptake above background), 2 (uptake ≤ mediastinum), or 3 (uptake \> mediastinum but ≤ liver) with/without a residual mass for lymph nodes and extralymphatic sites (LN/ELS); (2) no evidence of FDG-avid disease in bone marrow; (3) no new lesions. PR: (1) score of 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) with reduced uptake compared with Baseline and residual mass(es) of any size for LN/ELS; (2) residual uptake higher than in normal bone marrow but reduced from Baseline; (3) no new lesions. CT, CR: (1) target nodes/nodal masses regressed to ≤1.5 cm in LDi. no extra lymphatic site of disease; (2) absent nontarget lesions; (3) liver/spleen regressed to normal; (4) bone marrow normal by morphology; (5) no new lesions. PR: (1) ≥50% decrease in SPD of up to 6 target measurable nodes and extranodal sites; (2) no increase in target lesions; (3) spleen regressed by \>50% in length beyond normal; (4) no new lesions.
Time frame: up to approximately 34 months
Population: FL Full Analysis Set. The 2-sided 95% confidence intervals were calculated using the method of Brookmeyer and Crowley with log-log transformation. Only those participants who achieved an objective response (CR or PR) were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: Duration of Response (DOR; the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by Investigator Assessment | 21.19 months |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: Duration of Response (DOR; the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by Investigator Assessment | 13.60 months |
Secondary
FL Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment
The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-30 (EORTC QLQ-C30) version 3 is a 30-item scale composed of both multi-item scales and single-item measures. These include 5 functional scales (physical functioning, role, cognitive functioning, emotional functioning, and social functioning), 3 symptom scales (fatigue, pain, and nausea/vomiting), a global health status scale, and 6 single items (constipation, diarrhea, sleep, dyspnea, appetite, financial). All scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Therefore, a high score for a functional scale represents a high/healthy level of functioning and a high score for the global health status/QoL represents a high QoL. A high score for a symptom scale/item represents a high level of symptomatology/problems. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time frame: up to approximately 34 months
Population: FL Full Analysis Set. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | Baseline, Nausea and Vomiting | 2.7 scores on a scale | Standard Deviation 7.91 |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | End of Treatment, Nausea and Vomiting | 3.2 scores on a scale | Standard Deviation 10.61 |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | End of Treatment, Global Health Status | 67.7 scores on a scale | Standard Deviation 21.37 |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | Baseline, Pain | 16.0 scores on a scale | Standard Deviation 21.06 |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | Baseline, Cognitive Functioning | 88.0 scores on a scale | Standard Deviation 19.06 |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | End of Treatment, Pain | 17.8 scores on a scale | Standard Deviation 23.4 |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | Baseline, Dyspnea | 14.3 scores on a scale | Standard Deviation 23.79 |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | End of Treatment, Emotional Functioning | 79.0 scores on a scale | Standard Deviation 20.79 |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | End of Treatment, Dyspnea | 15.7 scores on a scale | Standard Deviation 23.54 |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | End of Treatment, Cognitive Functioning | 83.6 scores on a scale | Standard Deviation 20.45 |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | Baseline, Sleep | 26.1 scores on a scale | Standard Deviation 27.86 |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | End of Treatment, Physical Functioning | 80.1 scores on a scale | Standard Deviation 21.02 |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | End of Treatment, Sleep | 25.0 scores on a scale | Standard Deviation 28.67 |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | Baseline, Social Functioning | 84.7 scores on a scale | Standard Deviation 19.77 |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | Baseline, Appetite Loss | 10.2 scores on a scale | Standard Deviation 23.21 |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | Baseline, Role Functioning | 83.1 scores on a scale | Standard Deviation 22.72 |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | End of Treatment, Appetite Loss | 12.5 scores on a scale | Standard Deviation 23.46 |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | End of Treatment, Social Functioning | 79.8 scores on a scale | Standard Deviation 25.77 |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | Baseline, Constipation | 9.2 scores on a scale | Standard Deviation 19.55 |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | End of Treatment, Role Functioning | 77.3 scores on a scale | Standard Deviation 26.75 |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | End of Treatment, Constipation | 11.4 scores on a scale | Standard Deviation 22.16 |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | Baseline, Fatigue | 27.0 scores on a scale | Standard Deviation 23.43 |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | Baseline, Diarrhea | 7.0 scores on a scale | Standard Deviation 14.98 |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | Baseline, Emotional Functioning | 79.2 scores on a scale | Standard Deviation 19.04 |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | End of Treatment, Diarrhea | 12.7 scores on a scale | Standard Deviation 24.74 |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | End of Treatment, Fatigue | 30.5 scores on a scale | Standard Deviation 25.06 |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | Baseline, Financial Difficulties | 12.2 scores on a scale | Standard Deviation 23.34 |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | Baseline, Physical Functioning | 84.7 scores on a scale | Standard Deviation 17.44 |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | End of Treatment, Financial Difficulties | 11.8 scores on a scale | Standard Deviation 21.7 |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | Baseline, Global Health Status | 68.6 scores on a scale | Standard Deviation 20.44 |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | End of Treatment, Financial Difficulties | 12.7 scores on a scale | Standard Deviation 22.69 |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | Baseline, Physical Functioning | 84.1 scores on a scale | Standard Deviation 19.54 |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | End of Treatment, Role Functioning | 76.2 scores on a scale | Standard Deviation 29.09 |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | Baseline, Nausea and Vomiting | 2.9 scores on a scale | Standard Deviation 9.62 |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | End of Treatment, Pain | 20.2 scores on a scale | Standard Deviation 27.15 |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | Baseline, Global Health Status | 68.6 scores on a scale | Standard Deviation 21.93 |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | End of Treatment, Global Health Status | 67.5 scores on a scale | Standard Deviation 21 |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | End of Treatment, Physical Functioning | 81.0 scores on a scale | Standard Deviation 22.67 |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | Baseline, Role Functioning | 82.8 scores on a scale | Standard Deviation 24.72 |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | Baseline, Emotional Functioning | 79.2 scores on a scale | Standard Deviation 19.03 |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | End of Treatment, Emotional Functioning | 79.1 scores on a scale | Standard Deviation 21.36 |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | Baseline, Cognitive Functioning | 87.0 scores on a scale | Standard Deviation 17.25 |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | End of Treatment, Cognitive Functioning | 82.4 scores on a scale | Standard Deviation 21.03 |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | Baseline, Social Functioning | 83.4 scores on a scale | Standard Deviation 22.5 |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | End of Treatment, Social Functioning | 81.2 scores on a scale | Standard Deviation 23.63 |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | Baseline, Fatigue | 26.9 scores on a scale | Standard Deviation 24.71 |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | End of Treatment, Fatigue | 31.0 scores on a scale | Standard Deviation 25.39 |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | End of Treatment, Nausea and Vomiting | 3.7 scores on a scale | Standard Deviation 11.61 |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | Baseline, Pain | 17.6 scores on a scale | Standard Deviation 23.97 |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | Baseline, Dyspnea | 16.0 scores on a scale | Standard Deviation 24.88 |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | End of Treatment, Dyspnea | 17.5 scores on a scale | Standard Deviation 25.01 |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | Baseline, Sleep | 25.3 scores on a scale | Standard Deviation 27.5 |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | End of Treatment, Sleep | 27.7 scores on a scale | Standard Deviation 27.75 |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | Baseline, Appetite Loss | 11.4 scores on a scale | Standard Deviation 20.45 |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | End of Treatment, Appetite Loss | 12.3 scores on a scale | Standard Deviation 22.6 |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | Baseline, Constipation | 11.4 scores on a scale | Standard Deviation 20.86 |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | End of Treatment, Constipation | 12.5 scores on a scale | Standard Deviation 24.96 |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | Baseline, Diarrhea | 5.7 scores on a scale | Standard Deviation 15 |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | End of Treatment, Diarrhea | 12.5 scores on a scale | Standard Deviation 21.86 |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | Baseline, Financial Difficulties | 12.0 scores on a scale | Standard Deviation 20.37 |
Secondary
FL Population: Functional Assessment of Cancer Treatment-Lymphoma (FACT-Lym) Scores at Baseline and End of Treatment
The FACT-Lymphoma (v4) is composed of 42 items with a 5-point Likert-type scale and 5 subscales. Physical well-being (PWB) subscale: 7 items measured on 0- to 4-point scale; total score = 0-28. Social/family well-being (SWB) subscale: 7 items measured on 0- to 4-point scale; total score = 0-28. Emotional well-being (EWB) subscale: 6 items measured on 0- to 4-point scale; total score = 0-24. Functional well-being (FWB) subscale: 7 items measured on 0- to 4-point scale; total score = 0-28. Lymphoma (LymS) subscale includes 15 items; total score = 0-60. Three total scores can be derived by adding the subscales: FACT-Lymphoma Trial Outcome Index (TOI): (PWB score) + (FWB score) + (LymS score); total score = 0-116. FACT-G total score: (PWB score) + (SWB score) + (EWB score) + (FWB score); total score = 0-108. FACT-Lymphoma total score: (PWB score) + (SWB score) + (EWB score) + (FWB score) + (LymS score); total score = 0-168. The higher the score, the better the quality of life.
Time frame: up to approximately 34 months
Population: FL Full Analysis Set. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: Functional Assessment of Cancer Treatment-Lymphoma (FACT-Lym) Scores at Baseline and End of Treatment | Baseline, PWB subscale | 24.0 scores on a scale | Standard Deviation 4.26 |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: Functional Assessment of Cancer Treatment-Lymphoma (FACT-Lym) Scores at Baseline and End of Treatment | End of Treatment, PWB subscale | 23.5 scores on a scale | Standard Deviation 4.68 |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: Functional Assessment of Cancer Treatment-Lymphoma (FACT-Lym) Scores at Baseline and End of Treatment | Baseline, SWB subscale | 20.9 scores on a scale | Standard Deviation 5.82 |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: Functional Assessment of Cancer Treatment-Lymphoma (FACT-Lym) Scores at Baseline and End of Treatment | End of Treatment, SWB subscale | 19.9 scores on a scale | Standard Deviation 5.95 |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: Functional Assessment of Cancer Treatment-Lymphoma (FACT-Lym) Scores at Baseline and End of Treatment | Baseline, EWB subscale | 18.2 scores on a scale | Standard Deviation 4.21 |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: Functional Assessment of Cancer Treatment-Lymphoma (FACT-Lym) Scores at Baseline and End of Treatment | End of Treatment, EWB subscale | 18.3 scores on a scale | Standard Deviation 4.39 |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: Functional Assessment of Cancer Treatment-Lymphoma (FACT-Lym) Scores at Baseline and End of Treatment | Baseline, FWB subscale | 17.6 scores on a scale | Standard Deviation 6.12 |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: Functional Assessment of Cancer Treatment-Lymphoma (FACT-Lym) Scores at Baseline and End of Treatment | End of Treatment, FWB subscale | 16.5 scores on a scale | Standard Deviation 6.24 |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: Functional Assessment of Cancer Treatment-Lymphoma (FACT-Lym) Scores at Baseline and End of Treatment | Baseline, FACT-LymS | 47.7 scores on a scale | Standard Deviation 8.87 |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: Functional Assessment of Cancer Treatment-Lymphoma (FACT-Lym) Scores at Baseline and End of Treatment | End of Treatment, FACT-LymS | 48.0 scores on a scale | Standard Deviation 9.41 |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: Functional Assessment of Cancer Treatment-Lymphoma (FACT-Lym) Scores at Baseline and End of Treatment | Baseline, FACT-Lymphoma TOI | 89.3 scores on a scale | Standard Deviation 16.07 |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: Functional Assessment of Cancer Treatment-Lymphoma (FACT-Lym) Scores at Baseline and End of Treatment | End of Treatment, FACT-Lymphoma TOI | 88.0 scores on a scale | Standard Deviation 17.8 |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: Functional Assessment of Cancer Treatment-Lymphoma (FACT-Lym) Scores at Baseline and End of Treatment | Baseline, FACT-G Total Score | 80.7 scores on a scale | Standard Deviation 15.04 |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: Functional Assessment of Cancer Treatment-Lymphoma (FACT-Lym) Scores at Baseline and End of Treatment | End of Treatment, FACT-G Total Score | 78.3 scores on a scale | Standard Deviation 16.63 |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: Functional Assessment of Cancer Treatment-Lymphoma (FACT-Lym) Scores at Baseline and End of Treatment | Baseline, FACT-Lymphoma Total Score | 128.4 scores on a scale | Standard Deviation 21.81 |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: Functional Assessment of Cancer Treatment-Lymphoma (FACT-Lym) Scores at Baseline and End of Treatment | End of Treatment, FACT-Lymphoma Total Score | 126.1 scores on a scale | Standard Deviation 24.39 |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: Functional Assessment of Cancer Treatment-Lymphoma (FACT-Lym) Scores at Baseline and End of Treatment | End of Treatment, FACT-Lymphoma Total Score | 125.2 scores on a scale | Standard Deviation 24.65 |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: Functional Assessment of Cancer Treatment-Lymphoma (FACT-Lym) Scores at Baseline and End of Treatment | Baseline, PWB subscale | 24.3 scores on a scale | Standard Deviation 4.07 |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: Functional Assessment of Cancer Treatment-Lymphoma (FACT-Lym) Scores at Baseline and End of Treatment | Baseline, FACT-LymS | 47.7 scores on a scale | Standard Deviation 7.88 |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: Functional Assessment of Cancer Treatment-Lymphoma (FACT-Lym) Scores at Baseline and End of Treatment | End of Treatment, PWB subscale | 23.2 scores on a scale | Standard Deviation 5.42 |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: Functional Assessment of Cancer Treatment-Lymphoma (FACT-Lym) Scores at Baseline and End of Treatment | Baseline, FACT-G Total Score | 80.9 scores on a scale | Standard Deviation 15.08 |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: Functional Assessment of Cancer Treatment-Lymphoma (FACT-Lym) Scores at Baseline and End of Treatment | Baseline, SWB subscale | 20.5 scores on a scale | Standard Deviation 5.92 |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: Functional Assessment of Cancer Treatment-Lymphoma (FACT-Lym) Scores at Baseline and End of Treatment | End of Treatment, FACT-LymS | 48.0 scores on a scale | Standard Deviation 8.98 |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: Functional Assessment of Cancer Treatment-Lymphoma (FACT-Lym) Scores at Baseline and End of Treatment | End of Treatment, SWB subscale | 19.9 scores on a scale | Standard Deviation 5.31 |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: Functional Assessment of Cancer Treatment-Lymphoma (FACT-Lym) Scores at Baseline and End of Treatment | Baseline, FACT-Lymphoma Total Score | 128.6 scores on a scale | Standard Deviation 21.27 |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: Functional Assessment of Cancer Treatment-Lymphoma (FACT-Lym) Scores at Baseline and End of Treatment | Baseline, EWB subscale | 18.3 scores on a scale | Standard Deviation 4.06 |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: Functional Assessment of Cancer Treatment-Lymphoma (FACT-Lym) Scores at Baseline and End of Treatment | Baseline, FACT-Lymphoma TOI | 89.8 scores on a scale | Standard Deviation 15.51 |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: Functional Assessment of Cancer Treatment-Lymphoma (FACT-Lym) Scores at Baseline and End of Treatment | End of Treatment, EWB subscale | 18.1 scores on a scale | Standard Deviation 4.8 |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: Functional Assessment of Cancer Treatment-Lymphoma (FACT-Lym) Scores at Baseline and End of Treatment | End of Treatment, FACT-G Total Score | 77.3 scores on a scale | Standard Deviation 17.02 |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: Functional Assessment of Cancer Treatment-Lymphoma (FACT-Lym) Scores at Baseline and End of Treatment | Baseline, FWB subscale | 17.8 scores on a scale | Standard Deviation 5.98 |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: Functional Assessment of Cancer Treatment-Lymphoma (FACT-Lym) Scores at Baseline and End of Treatment | End of Treatment, FACT-Lymphoma TOI | 87.3 scores on a scale | Standard Deviation 18.59 |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: Functional Assessment of Cancer Treatment-Lymphoma (FACT-Lym) Scores at Baseline and End of Treatment | End of Treatment, FWB subscale | 16.3 scores on a scale | Standard Deviation 6.19 |
Secondary
FL Population: Health State EQ-5D-5L Scores at Baseline and End of Treatment
The EQ-5D-5L contains a participant-reported score regarding health state measured on a visual analog scale (scores range from 0 \[worst imaginable health state\] to 100 \[best imaginable health state\]), and 5 questions on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The 5 questions have 5 response levels: 1, no problems; 2, slight problems; 3, moderate problems; 4, severe problems; and 5, unable to/extreme problems.
Time frame: up to approximately 34 months
Population: FL Full Analysis Set. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: Health State EQ-5D-5L Scores at Baseline and End of Treatment | Baseline | 72.5 scores on a scale | Standard Deviation 18.15 |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: Health State EQ-5D-5L Scores at Baseline and End of Treatment | End of Treatment | 73.7 scores on a scale | Standard Deviation 18.21 |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: Health State EQ-5D-5L Scores at Baseline and End of Treatment | Baseline | 73.6 scores on a scale | Standard Deviation 19.13 |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: Health State EQ-5D-5L Scores at Baseline and End of Treatment | End of Treatment | 72.5 scores on a scale | Standard Deviation 19.17 |
Secondary
FL Population: Kaplan-Meier Estimates of DOR (the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by Investigator Assessment
PET, CR: (1) score of 1 (no uptake above background), 2 (uptake ≤ mediastinum), or 3 (uptake \> mediastinum but ≤ liver) with/without a residual mass for lymph nodes and extralymphatic sites (LN/ELS); (2) no evidence of FDG-avid disease in bone marrow; (3) no new lesions. PR: (1) score of 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) with reduced uptake compared with Baseline and residual mass(es) of any size for LN/ELS; (2) residual uptake higher than in normal bone marrow but reduced from Baseline; (3) no new lesions. CT, CR: (1) target nodes/nodal masses regressed to ≤1.5 cm in LDi. no extra lymphatic site of disease; (2) absent nontarget lesions; (3) liver/spleen regressed to normal; (4) bone marrow normal by morphology; (5) no new lesions. PR: (1) ≥50% decrease in SPD of up to 6 target measurable nodes and extranodal sites; (2) no increase in target lesions; (3) spleen regressed by \>50% in length beyond normal; (4) no new lesions.
Time frame: up to 2 years
Population: FL Full Analysis Set. Only those participants who achieved an objective response (CR or PR) were analyzed. Kaplan-Meier estimates indicate the percent probability of a participant still having a CR or PR at the indicated time after treatment start. The number of participants analyzed for the Kaplan-Meier estimate at each time point refers to the total number of participants in the analysis set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: Kaplan-Meier Estimates of DOR (the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by Investigator Assessment | 12 months | 76.3 percent probability |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: Kaplan-Meier Estimates of DOR (the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by Investigator Assessment | 18 months | 63.7 percent probability |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: Kaplan-Meier Estimates of DOR (the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by Investigator Assessment | 2 years | 39.5 percent probability |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: Kaplan-Meier Estimates of DOR (the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by Investigator Assessment | 6 months | 91.5 percent probability |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: Kaplan-Meier Estimates of DOR (the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by Investigator Assessment | 2 years | 33.3 percent probability |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: Kaplan-Meier Estimates of DOR (the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by Investigator Assessment | 6 months | 77.8 percent probability |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: Kaplan-Meier Estimates of DOR (the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by Investigator Assessment | 18 months | 42.9 percent probability |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: Kaplan-Meier Estimates of DOR (the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by Investigator Assessment | 12 months | 59.1 percent probability |
p-value: <0.000195% CI: [0.33, 0.678]stratified Log Rank
Secondary
FL Population: Kaplan-Meier Estimates of DOR (the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by IRC Review
PET, CR: (1) score of 1 (no uptake above background), 2 (uptake ≤ mediastinum), or 3 (uptake \> mediastinum but ≤ liver) with/without a residual mass for lymph nodes and extralymphatic sites (LN/ELS); (2) no evidence of FDG-avid disease in bone marrow; (3) no new lesions. PR: (1) score of 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) with reduced uptake compared with Baseline and residual mass(es) of any size for LN/ELS; (2) residual uptake higher than in normal bone marrow but reduced from Baseline; (3) no new lesions. CT, CR: (1) target nodes/nodal masses regressed to ≤1.5 cm in LDi. no extra lymphatic site of disease; (2) absent nontarget lesions; (3) liver/spleen regressed to normal; (4) bone marrow normal by morphology; (5) no new lesions. PR: (1) ≥50% decrease in SPD of up to 6 target measurable nodes and extranodal sites; (2) no increase in target lesions; (3) spleen regressed by \>50% in length beyond normal; (4) no new lesions.
Time frame: up to 2 years
Population: FL Full Analysis Set. Only those participants who achieved an objective response (CR or PR) were analyzed. Kaplan-Meier estimates indicate the percent probability of a participant still having a CR or PR at the indicated time after treatment start. The number of participants analyzed for the Kaplan-Meier estimate at each time point refers to the total number of participants in the analysis set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: Kaplan-Meier Estimates of DOR (the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by IRC Review | 18 months | 64.3 percent probability |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: Kaplan-Meier Estimates of DOR (the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by IRC Review | 12 months | 78.8 percent probability |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: Kaplan-Meier Estimates of DOR (the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by IRC Review | 2 years | 58.2 percent probability |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: Kaplan-Meier Estimates of DOR (the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by IRC Review | 6 months | 92.4 percent probability |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: Kaplan-Meier Estimates of DOR (the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by IRC Review | 2 years | 35.5 percent probability |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: Kaplan-Meier Estimates of DOR (the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by IRC Review | 6 months | 78.7 percent probability |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: Kaplan-Meier Estimates of DOR (the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by IRC Review | 18 months | 52.2 percent probability |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: Kaplan-Meier Estimates of DOR (the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by IRC Review | 12 months | 61.4 percent probability |
p-value: <0.000195% CI: [0.312, 0.681]stratified Log Rank
Secondary
FL Population: Kaplan-Meier Estimates of Overall Survival
Overall survival was defined as the time from randomization until death from any cause. Kaplan-Meier estimates indicate the percent probability of a participant being alive at the indicated time after treatment start.
Time frame: up to 2 years
Population: FL Full Analysis Set. Censored participants were included in the analysis. The number of participants analyzed for the Kaplan-Meier estimate at each time point refers to the total number of participants in the analysis set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: Kaplan-Meier Estimates of Overall Survival | 18 months | 93.8 percent probability |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: Kaplan-Meier Estimates of Overall Survival | 12 months | 96.4 percent probability |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: Kaplan-Meier Estimates of Overall Survival | 2 years | 92.5 percent probability |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: Kaplan-Meier Estimates of Overall Survival | 6 months | 99.3 percent probability |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: Kaplan-Meier Estimates of Overall Survival | 2 years | 85.5 percent probability |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: Kaplan-Meier Estimates of Overall Survival | 12 months | 93.7 percent probability |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: Kaplan-Meier Estimates of Overall Survival | 18 months | 90.1 percent probability |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: Kaplan-Meier Estimates of Overall Survival | 6 months | 96.2 percent probability |
p-value: 0.106195% CI: [0.306, 1.128]stratified Log Rank
Secondary
FL Population: Kaplan-Meier Estimates of PFS by IRC Review, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First
PD, PET: score 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) for lymph node/extra lymphatic sites with increase in intensity of Baseline uptake and/or new FDG-avid foci consistent with lymphoma at interim/end-of-treatment assessment; new/recurrent FDG-avid foci in bone marrow; new FDG-avid foci consistent with lymphoma versus other etiology in new lesions. PD, CT: abnormal individual node/lesion with LDi \>1.5 cm and increase by ≥50% from the PPD nadir and increase in LDi or SDi from nadir; new/clear progression of preexisting nontarget lesions; new/recurrent splenomegaly and bone marrow involvement; regrowth of previously resolved lesions. New node \>1.5 cm in any axis. New extranodal site \>1.0 cm in any axis; if \<1.0 cm, presence is unequivocal and attributable to lymphoma. Kaplan-Meier estimates indicate the percent probability of a participant being alive at the indicated time after treatment start.
Time frame: up to 2 years
Population: FL Full Analysis Set. Censored participants were included in the analysis. The number of participants analyzed for the Kaplan-Meier estimate at each time point refers to the total number of participants in the analysis set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: Kaplan-Meier Estimates of PFS by IRC Review, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First | 2 years | 53.9 percent probability |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: Kaplan-Meier Estimates of PFS by IRC Review, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First | 6 months | 94.0 percent probability |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: Kaplan-Meier Estimates of PFS by IRC Review, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First | 12 months | 83.1 percent probability |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: Kaplan-Meier Estimates of PFS by IRC Review, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First | 18 months | 67.5 percent probability |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: Kaplan-Meier Estimates of PFS by IRC Review, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First | 18 months | 45.8 percent probability |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: Kaplan-Meier Estimates of PFS by IRC Review, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First | 2 years | 35.0 percent probability |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: Kaplan-Meier Estimates of PFS by IRC Review, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First | 12 months | 59.8 percent probability |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: Kaplan-Meier Estimates of PFS by IRC Review, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First | 6 months | 80.3 percent probability |
p-value: <0.000195% CI: [0.294, 0.563]stratified Log Rank
Secondary
FL Population: Minimal Residual Disease (MRD)-Negativity Rate (at Threshold of 10^-5) at End of Treatment
The MRD-negativity rate was defined as the percentage of participants who achieved a negative MRD result in peripheral blood at the End of Treatment. The threshold used for the analysis was 10\^-5 cells. MRD status was only analyzed with a threshold of ≤10\^-5 cells for MRD negativity.
Time frame: up to approximately 34 months
Population: FL MRD Blood-Evaluable Set: all participants in the Full Analysis Set with FL who received at least 1 dose of study treatment with identifiable clonality in blood samples at Cycle 1 Day 1. The 95% confidence intervals were calculated using the Clopper-Pearson method. Participants who did not have a post-baseline assessment were considered to be not assessed, but were included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: Minimal Residual Disease (MRD)-Negativity Rate (at Threshold of 10^-5) at End of Treatment | 26.3 percentage of participants |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: Minimal Residual Disease (MRD)-Negativity Rate (at Threshold of 10^-5) at End of Treatment | 18.2 percentage of participants |
p-value: 0.409395% CI: [0.61, 3.33]stratified Cochran-Mantel-Haenszel
Secondary
FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
The EQ-5D-5L contains a participant-reported score regarding health state measured on a visual analog scale (scores range from 0 \[worst imaginable health state\] to 100 \[best imaginable health state\]), and 5 questions on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The 5 questions have 5 response levels: 1, no problems; 2, slight problems; 3, moderate problems; 4, severe problems; and 5, unable to/extreme problems.
Time frame: up to approximately 34 months
Population: FL Full Analysis Set. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | Baseline, Usual Activities, Score 4 | 4 Participants |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | Baseline, Self-care, Score 1 | 250 Participants |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | Baseline, Usual Activities, Score 5 | 5 Participants |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | Baseline, Mobility, Score 4 | 4 Participants |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | End of Treatment, Usual Activities, Score 1 | 107 Participants |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | Baseline, Self-care, Score 2 | 9 Participants |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | End of Treatment, Usual Activities, Score 2 | 58 Participants |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | Baseline, Mobility, Score 1 | 185 Participants |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | Baseline, Self-care, Score 3 | 3 Participants |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | End of Treatment, Usual Activities, Score 4 | 7 Participants |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | Baseline, Mobility, Score 5 | 1 Participants |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | End of Treatment, Usual Activities, Score 5 | 1 Participants |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | Baseline, Self-care, Score 4 | 1 Participants |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | Baseline, Pain/Discomfort, Score 1 | 144 Participants |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | Baseline, Pain/Discomfort, Score 2 | 92 Participants |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | Baseline, Self-care, Score 5 | 1 Participants |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | Baseline, Pain/Discomfort, Score 3 | 25 Participants |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | End of Treatment, Mobility, Score 1 | 122 Participants |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | Baseline, Pain/Discomfort, Score 4 | 2 Participants |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | Baseline, Pain/Discomfort, Score 5 | 1 Participants |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | End of Treatment, Self-care, Score 1 | 165 Participants |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | End of Treatment, Pain/Discomfort, Score 1 | 106 Participants |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | Baseline, Mobility, Score 2 | 58 Participants |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | End of Treatment, Pain/Discomfort, Score 2 | 55 Participants |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | End of Treatment, Self-care, Score 2 | 12 Participants |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | End of Treatment, Mobility, Score 2 | 39 Participants |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | End of Treatment, Pain/Discomfort, Score 4 | 8 Participants |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | End of Treatment, Self-care, Score 3 | 6 Participants |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | End of Treatment, Pain/Discomfort, Score 5 | 0 Participants |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | End of Treatment, Usual Activities, Score 3 | 13 Participants |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | Baseline, Anxiety/Depression, Score 1 | 138 Participants |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | End of Treatment, Self-care, Score 4 | 3 Participants |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | Baseline, Anxiety/Depression, Score 2 | 98 Participants |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | End of Treatment, Mobility, Score 3 | 14 Participants |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | Baseline, Anxiety/Depression, Score 3 | 22 Participants |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | End of Treatment, Self-care, Score 5 | 0 Participants |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | Baseline, Anxiety/Depression, Score 4 | 5 Participants |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | Baseline, Mobility, Score 3 | 16 Participants |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | Baseline, Anxiety/Depression, Score 5 | 1 Participants |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | Baseline, Usual Activities, Score 1 | 179 Participants |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | End of Treatment, Anxiety/Depression, Score 1 | 107 Participants |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | End of Treatment, Mobility, Score 4 | 9 Participants |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | End of Treatment, Anxiety/Depression, Score 2 | 58 Participants |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | Baseline, Usual Activities, Score 2 | 59 Participants |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | End of Treatment, Anxiety/Depression, Score 3 | 18 Participants |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | End of Treatment, Mobility, Score 5 | 2 Participants |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | End of Treatment, Anxiety/Depression, Score 4 | 1 Participants |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | Baseline, Usual Activities, Score 3 | 17 Participants |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | End of Treatment, Anxiety/Depression, Score 5 | 2 Participants |
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | End of Treatment, Pain/Discomfort, Score 3 | 17 Participants |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | End of Treatment, Anxiety/Depression, Score 5 | 0 Participants |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | Baseline, Pain/Discomfort, Score 4 | 7 Participants |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | Baseline, Mobility, Score 1 | 198 Participants |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | Baseline, Mobility, Score 2 | 34 Participants |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | Baseline, Mobility, Score 3 | 25 Participants |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | Baseline, Mobility, Score 4 | 8 Participants |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | Baseline, Mobility, Score 5 | 0 Participants |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | End of Treatment, Mobility, Score 1 | 126 Participants |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | End of Treatment, Mobility, Score 2 | 34 Participants |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | End of Treatment, Mobility, Score 3 | 17 Participants |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | End of Treatment, Mobility, Score 5 | 1 Participants |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | Baseline, Self-care, Score 1 | 243 Participants |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | Baseline, Self-care, Score 2 | 16 Participants |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | Baseline, Self-care, Score 3 | 4 Participants |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | Baseline, Self-care, Score 4 | 1 Participants |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | Baseline, Self-care, Score 5 | 1 Participants |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | End of Treatment, Self-care, Score 1 | 166 Participants |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | End of Treatment, Self-care, Score 2 | 9 Participants |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | End of Treatment, Self-care, Score 3 | 7 Participants |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | End of Treatment, Self-care, Score 4 | 5 Participants |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | End of Treatment, Self-care, Score 5 | 0 Participants |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | Baseline, Usual Activities, Score 1 | 184 Participants |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | Baseline, Usual Activities, Score 2 | 50 Participants |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | Baseline, Usual Activities, Score 3 | 26 Participants |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | Baseline, Usual Activities, Score 4 | 4 Participants |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | Baseline, Usual Activities, Score 5 | 1 Participants |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | End of Treatment, Usual Activities, Score 1 | 114 Participants |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | End of Treatment, Usual Activities, Score 2 | 47 Participants |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | End of Treatment, Usual Activities, Score 3 | 16 Participants |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | End of Treatment, Usual Activities, Score 4 | 5 Participants |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | End of Treatment, Usual Activities, Score 5 | 5 Participants |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | Baseline, Pain/Discomfort, Score 1 | 141 Participants |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | Baseline, Pain/Discomfort, Score 2 | 82 Participants |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | Baseline, Pain/Discomfort, Score 3 | 34 Participants |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | Baseline, Pain/Discomfort, Score 5 | 1 Participants |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | End of Treatment, Pain/Discomfort, Score 1 | 104 Participants |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | End of Treatment, Pain/Discomfort, Score 2 | 51 Participants |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | End of Treatment, Pain/Discomfort, Score 3 | 21 Participants |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | End of Treatment, Pain/Discomfort, Score 4 | 8 Participants |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | End of Treatment, Pain/Discomfort, Score 5 | 3 Participants |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | Baseline, Anxiety/Depression, Score 1 | 152 Participants |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | Baseline, Anxiety/Depression, Score 2 | 79 Participants |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | Baseline, Anxiety/Depression, Score 3 | 26 Participants |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | Baseline, Anxiety/Depression, Score 4 | 7 Participants |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | Baseline, Anxiety/Depression, Score 5 | 1 Participants |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | End of Treatment, Anxiety/Depression, Score 1 | 103 Participants |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | End of Treatment, Anxiety/Depression, Score 2 | 60 Participants |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | End of Treatment, Anxiety/Depression, Score 3 | 20 Participants |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | End of Treatment, Anxiety/Depression, Score 4 | 4 Participants |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | End of Treatment, Mobility, Score 4 | 9 Participants |
Secondary
FL Population: Overall Response Rate (Percentage of Participants Who Achieved a CR/PR Per the Lugano Classification at Any Time During the Study But Before the First PD and Before/at the Start of a New Antilymphoma Treatment) by Investigator Assessment
PET, CR: (1) score of 1 (no uptake above background), 2 (uptake ≤ mediastinum), or 3 (uptake \> mediastinum but ≤ liver) with/without a residual mass for lymph nodes and extralymphatic sites (LN/ELS); (2) no evidence of FDG-avid disease in bone marrow; (3) no new lesions. PR: (1) score of 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) with reduced uptake compared with Baseline and residual mass(es) of any size for LN/ELS; (2) residual uptake higher than in normal bone marrow but reduced from Baseline; (3) no new lesions. CT, CR: (1) target nodes/nodal masses regressed to ≤1.5 cm in LDi. no extra lymphatic site of disease; (2) absent nontarget lesions; (3) liver/spleen regressed to normal; (4) bone marrow normal by morphology; (5) no new lesions. PR: (1) ≥50% decrease in SPD of up to 6 target measurable nodes and extranodal sites; (2) no increase in target lesions; (3) spleen regressed by \>50% in length beyond normal; (4) no new lesions.
Time frame: up to approximately 34 months
Population: FL Full Analysis Set. The 95% confidence intervals were calculated using the Clopper-Pearson method.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: Overall Response Rate (Percentage of Participants Who Achieved a CR/PR Per the Lugano Classification at Any Time During the Study But Before the First PD and Before/at the Start of a New Antilymphoma Treatment) by Investigator Assessment | 83.5 percentage of participants |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: Overall Response Rate (Percentage of Participants Who Achieved a CR/PR Per the Lugano Classification at Any Time During the Study But Before the First PD and Before/at the Start of a New Antilymphoma Treatment) by Investigator Assessment | 72.4 percentage of participants |
p-value: 0.001495% CI: [1.3, 3.02]stratified Cochran-Mantel-Haenszel
Secondary
FL Population: Overall Response Rate (Percentage of Participants Who Achieved a CR/PR Per the Lugano Classification at Any Time During the Study But Before the First PD and Before/at the Start of a New Antilymphoma Treatment) by IRC Review
PET, CR: (1) score of 1 (no uptake above background), 2 (uptake ≤ mediastinum), or 3 (uptake \> mediastinum but ≤ liver) with/without a residual mass for lymph nodes and extralymphatic sites (LN/ELS); (2) no evidence of FDG-avid disease in bone marrow; (3) no new lesions. PR: (1) score of 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) with reduced uptake compared with Baseline and residual mass(es) of any size for LN/ELS; (2) residual uptake higher than in normal bone marrow but reduced from Baseline; (3) no new lesions. CT, CR: (1) target nodes/nodal masses regressed to ≤1.5 cm in LDi. no extra lymphatic site of disease; (2) absent nontarget lesions; (3) liver/spleen regressed to normal; (4) bone marrow normal by morphology; (5) no new lesions. PR: (1) ≥50% decrease in SPD of up to 6 target measurable nodes and extranodal sites; (2) no increase in target lesions; (3) spleen regressed by \>50% in length beyond normal; (4) no new lesions.
Time frame: up to approximately 34 months
Population: FL Full Analysis Set. The 95% confidence intervals were calculated using the Clopper-Pearson method.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: Overall Response Rate (Percentage of Participants Who Achieved a CR/PR Per the Lugano Classification at Any Time During the Study But Before the First PD and Before/at the Start of a New Antilymphoma Treatment) by IRC Review | 85.7 percentage of participants |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: Overall Response Rate (Percentage of Participants Who Achieved a CR/PR Per the Lugano Classification at Any Time During the Study But Before the First PD and Before/at the Start of a New Antilymphoma Treatment) by IRC Review | 73.5 percentage of participants |
p-value: 0.000395% CI: [1.43, 3.43]stratified Cochran-Mantel-Haenszel
Secondary
FL Population: Overall Survival
Overall survival was defined as the time from randomization until death from any cause.
Time frame: up to approximately 34 months
Population: FL Full Analysis Set. The 2-sided 95% confidence intervals were calculated using the method of Brookmeyer and Crowley with log-log transformation. Censored participants were included in the analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: Overall Survival | NA months |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: Overall Survival | NA months |
Secondary
FL Population: PFS by IRC Review, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First
PD, PET: score 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) for lymph node/extra lymphatic sites with increase in intensity of Baseline uptake and/or new FDG-avid foci consistent with lymphoma at interim/end-of-treatment assessment; new/recurrent FDG-avid foci in bone marrow; new FDG-avid foci consistent with lymphoma versus other etiology in new lesions. PD, CT: abnormal individual node/lesion with LDi \>1.5 cm and increase by ≥50% from the PPD nadir and increase in LDi or SDi from nadir; new/clear progression of preexisting nontarget lesions; new/recurrent splenomegaly and bone marrow involvement; regrowth of previously resolved lesions. New node \>1.5 cm in any axis. New extranodal site \>1.0 cm in any axis; if \<1.0 cm, presence is unequivocal and attributable to lymphoma.
Time frame: up to approximately 34 months
Population: FL Full Analysis Set. The 2-sided 95% confidence intervals were calculated using the method of Brookmeyer and Crowley with log-log transformation. Censored participants were included in the analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| FL: Tafasitamab + Rituximab + Lenalidomide | FL Population: PFS by IRC Review, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First | NA months |
| FL: Placebo + Rituximab + Lenalidomide | FL Population: PFS by IRC Review, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First | 16.00 months |
Secondary
Overall Population: DOR (the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by Investigator Assessment
PET, CR: (1) score of 1 (no uptake above background), 2 (uptake ≤ mediastinum), or 3 (uptake \> mediastinum but ≤ liver) with/without a residual mass for lymph nodes and extralymphatic sites (LN/ELS); (2) no evidence of FDG-avid disease in bone marrow; (3) no new lesions. PR: (1) score of 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) with reduced uptake compared with Baseline and residual mass(es) of any size for LN/ELS; (2) residual uptake higher than in normal bone marrow but reduced from Baseline; (3) no new lesions. CT, CR: (1) target nodes/nodal masses regressed to ≤1.5 cm in LDi. no extra lymphatic site of disease; (2) absent nontarget lesions; (3) liver/spleen regressed to normal; (4) bone marrow normal by morphology; (5) no new lesions. PR: (1) ≥50% decrease in SPD of up to 6 target measurable nodes and extranodal sites; (2) no increase in target lesions; (3) spleen regressed by \>50% in length beyond normal; (4) no new lesions.
Time frame: up to approximately 34 months
Population: Overall Full Analysis Set. As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. The 2-sided 95% confidence intervals were calculated using the method of Brookmeyer and Crowley with log-log transformation. Only participants who achieved an objective response (CR or PR) were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: DOR (the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by Investigator Assessment | 22.24 months |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: DOR (the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by Investigator Assessment | 17.77 months |
Secondary
Overall Population: DOR (the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by IRC Review
PET, CR: (1) score of 1 (no uptake above background), 2 (uptake ≤ mediastinum), or 3 (uptake \> mediastinum but ≤ liver) with/without a residual mass for lymph nodes and extralymphatic sites (LN/ELS); (2) no evidence of FDG-avid disease in bone marrow; (3) no new lesions. PR: (1) score of 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) with reduced uptake compared with Baseline and residual mass(es) of any size for LN/ELS; (2) residual uptake higher than in normal bone marrow but reduced from Baseline; (3) no new lesions. CT, CR: (1) target nodes/nodal masses regressed to ≤1.5 cm in LDi. no extra lymphatic site of disease; (2) absent nontarget lesions; (3) liver/spleen regressed to normal; (4) bone marrow normal by morphology; (5) no new lesions. PR: (1) ≥50% decrease in SPD of up to 6 target measurable nodes and extranodal sites; (2) no increase in target lesions; (3) spleen regressed by \>50% in length beyond normal; (4) no new lesions.
Time frame: up to approximately 34 months
Population: Overall Full Analysis Set. As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. The 2-sided 95% confidence intervals were calculated using the method of Brookmeyer and Crowley with log-log transformation. Only participants who achieved an objective response (CR or PR) were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: DOR (the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by IRC Review | NA months |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: DOR (the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by IRC Review | 18.83 months |
Secondary
Overall Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment
The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-30 (EORTC QLQ-C30) version 3 is a 30-item scale composed of both multi-item scales and single-item measures. These include 5 functional scales (physical functioning, role, cognitive functioning, emotional functioning, and social functioning), 3 symptom scales (fatigue, pain, and nausea/vomiting), a global health status scale, and 6 single items (constipation, diarrhea, sleep, dyspnea, appetite, financial). All scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Therefore, a high score for a functional scale represents a high/healthy level of functioning and a high score for the global health status/QoL represents a high QoL. A high score for a symptom scale/item represents a high level of symptomatology/problems. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time frame: up to approximately 34 months
Population: Overall Full Analysis Set. As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | End of Treatment, Nausea and Vomiting | 3.4 scores on a scale | Standard Deviation 10.56 |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | Baseline, Cognitive Functioning | 87.6 scores on a scale | Standard Deviation 18.79 |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | Baseline, Pain | 17.2 scores on a scale | Standard Deviation 22.35 |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | End of Treatment, Global Health Status | 68.2 scores on a scale | Standard Deviation 20.96 |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | End of Treatment, Pain | 17.9 scores on a scale | Standard Deviation 23.73 |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | End of Treatment, Cognitive Functioning | 83.6 scores on a scale | Standard Deviation 20.09 |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | Baseline, Dyspnea | 15.8 scores on a scale | Standard Deviation 24.79 |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | End of Treatment, Role Functioning | 78.1 scores on a scale | Standard Deviation 26.41 |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | End of Treatment, Dyspnea | 16.2 scores on a scale | Standard Deviation 24.5 |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | Baseline, Social functioning | 84.6 scores on a scale | Standard Deviation 19.94 |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | Baseline, Sleep | 27.8 scores on a scale | Standard Deviation 29.41 |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | End of Treatment, Physical Functioning | 80.3 scores on a scale | Standard Deviation 21.21 |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | End of Treatment, Sleep | 25.7 scores on a scale | Standard Deviation 29.33 |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | End of Treatment, Social Functioning | 81.0 scores on a scale | Standard Deviation 25.37 |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | Baseline, Appetite Loss | 11.2 scores on a scale | Standard Deviation 24.51 |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | Baseline, Emotional Functioning | 79.5 scores on a scale | Standard Deviation 19.36 |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | End of Treatment, Appetite Loss | 12.6 scores on a scale | Standard Deviation 23.35 |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | Baseline, Fatigue | 28.5 scores on a scale | Standard Deviation 24.55 |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | Baseline, Constipation | 9.8 scores on a scale | Standard Deviation 20.7 |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | Baseline, Physical Functioning | 83.2 scores on a scale | Standard Deviation 18.07 |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | End of Treatment, Constipation | 11.7 scores on a scale | Standard Deviation 23.37 |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | End of Treatment, Fatigue | 30.1 scores on a scale | Standard Deviation 24.52 |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | Baseline, Diarrhea | 7.5 scores on a scale | Standard Deviation 16.02 |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | End of Treatment, Emotional Functioning | 80.2 scores on a scale | Standard Deviation 20.55 |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | End of Treatment, Diarrhea | 12.5 scores on a scale | Standard Deviation 23.95 |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | Baseline, Nausea and Vomiting | 2.8 scores on a scale | Standard Deviation 9.31 |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | Baseline, Financial Difficulties | 11.9 scores on a scale | Standard Deviation 22.58 |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | Baseline, Role Functioning | 82.2 scores on a scale | Standard Deviation 23.85 |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | End of Treatment, Financial Difficulties | 11.4 scores on a scale | Standard Deviation 21.12 |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | Baseline, Global Health Status | 68.5 scores on a scale | Standard Deviation 20.59 |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | End of Treatment, Financial Difficulties | 12.2 scores on a scale | Standard Deviation 21.99 |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | Baseline, Global Health Status | 67.3 scores on a scale | Standard Deviation 22.67 |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | End of Treatment, Global Health Status | 66.6 scores on a scale | Standard Deviation 21.24 |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | Baseline, Physical Functioning | 82.8 scores on a scale | Standard Deviation 20.2 |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | End of Treatment, Physical Functioning | 80.2 scores on a scale | Standard Deviation 22.34 |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | Baseline, Role Functioning | 81.1 scores on a scale | Standard Deviation 25.48 |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | End of Treatment, Role Functioning | 75.5 scores on a scale | Standard Deviation 28.94 |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | Baseline, Emotional Functioning | 78.8 scores on a scale | Standard Deviation 19.31 |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | End of Treatment, Emotional Functioning | 79.1 scores on a scale | Standard Deviation 21.22 |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | Baseline, Cognitive Functioning | 86.8 scores on a scale | Standard Deviation 17.03 |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | End of Treatment, Cognitive Functioning | 82.6 scores on a scale | Standard Deviation 20.87 |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | Baseline, Social functioning | 82.3 scores on a scale | Standard Deviation 23.47 |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | End of Treatment, Social Functioning | 81.5 scores on a scale | Standard Deviation 22.86 |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | Baseline, Fatigue | 28.3 scores on a scale | Standard Deviation 25.77 |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | End of Treatment, Fatigue | 31.0 scores on a scale | Standard Deviation 25.08 |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | Baseline, Nausea and Vomiting | 2.9 scores on a scale | Standard Deviation 9.16 |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | End of Treatment, Nausea and Vomiting | 4.1 scores on a scale | Standard Deviation 12.34 |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | Baseline, Pain | 17.8 scores on a scale | Standard Deviation 23.89 |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | End of Treatment, Pain | 19.7 scores on a scale | Standard Deviation 26.42 |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | Baseline, Dyspnea | 17.2 scores on a scale | Standard Deviation 26.27 |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | End of Treatment, Dyspnea | 18.5 scores on a scale | Standard Deviation 25.8 |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | Baseline, Sleep | 25.9 scores on a scale | Standard Deviation 27.2 |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | End of Treatment, Sleep | 26.8 scores on a scale | Standard Deviation 27.81 |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | Baseline, Appetite Loss | 11.5 scores on a scale | Standard Deviation 20.31 |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | End of Treatment, Appetite Loss | 12.9 scores on a scale | Standard Deviation 23.4 |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | Baseline, Constipation | 10.8 scores on a scale | Standard Deviation 20.46 |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | End of Treatment, Constipation | 12.7 scores on a scale | Standard Deviation 24.62 |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | Baseline, Diarrhea | 5.6 scores on a scale | Standard Deviation 14.81 |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | End of Treatment, Diarrhea | 13.7 scores on a scale | Standard Deviation 23.53 |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment | Baseline, Financial Difficulties | 12.5 scores on a scale | Standard Deviation 21.2 |
Secondary
Overall Population: FACT-Lym Scores at Baseline and End of Treatment
The FACT-Lymphoma (v4) is composed of 42 items with a 5-point Likert-type scale and 5 subscales. Physical well-being (PWB) subscale: 7 items measured on 0- to 4-point scale; total score = 0-28. Social/family well-being (SWB) subscale: 7 items measured on 0- to 4-point scale; total score = 0-28. Emotional well-being (EWB) subscale: 6 items measured on 0- to 4-point scale; total score = 0-24. Functional well-being (FWB) subscale: 7 items measured on 0- to 4-point scale; total score = 0-28. Lymphoma (LymS) subscale includes 15 items; total score = 0-60. Three total scores can be derived by adding the subscales: FACT-Lymphoma Trial Outcome Index (TOI): (PWB score) + (FWB score) + (LymS score); total score = 0-116. FACT-G total score: (PWB score) + (SWB score) + (EWB score) + (FWB score); total score = 0-108. FACT-Lymphoma total score: (PWB score) + (SWB score) + (EWB score) + (FWB score) + (LymS score); total score = 0-168. The higher the score, the better the quality of life.
Time frame: up to approximately 34 months
Population: Overall Full Analysis Set. As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: FACT-Lym Scores at Baseline and End of Treatment | Baseline, PWB subscale | 23.8 scores on a scale | Standard Deviation 4.41 |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: FACT-Lym Scores at Baseline and End of Treatment | End of Treatment, PWB subscale | 23.6 scores on a scale | Standard Deviation 4.71 |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: FACT-Lym Scores at Baseline and End of Treatment | Baseline, SWB subscale | 20.8 scores on a scale | Standard Deviation 5.82 |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: FACT-Lym Scores at Baseline and End of Treatment | End of Treatment, SWB subscale | 20.2 scores on a scale | Standard Deviation 5.89 |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: FACT-Lym Scores at Baseline and End of Treatment | Baseline, EWB subscale | 18.2 scores on a scale | Standard Deviation 4.2 |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: FACT-Lym Scores at Baseline and End of Treatment | End of Treatment, EWB subscale | 18.7 scores on a scale | Standard Deviation 4.31 |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: FACT-Lym Scores at Baseline and End of Treatment | Baseline, FWB subscale | 17.3 scores on a scale | Standard Deviation 6.19 |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: FACT-Lym Scores at Baseline and End of Treatment | End of Treatment, FWB subscale | 16.8 scores on a scale | Standard Deviation 6.29 |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: FACT-Lym Scores at Baseline and End of Treatment | Baseline, FACT-LymS | 47.4 scores on a scale | Standard Deviation 8.91 |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: FACT-Lym Scores at Baseline and End of Treatment | End of Treatment, FACT-LymS | 48.7 scores on a scale | Standard Deviation 9.17 |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: FACT-Lym Scores at Baseline and End of Treatment | Baseline, FACT-Lymphoma TOI | 88.7 scores on a scale | Standard Deviation 16.4 |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: FACT-Lym Scores at Baseline and End of Treatment | End of Treatment, FACT-Lymphoma TOI | 89.0 scores on a scale | Standard Deviation 17.74 |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: FACT-Lym Scores at Baseline and End of Treatment | Baseline, FACT-G Total Score | 80.2 scores on a scale | Standard Deviation 15.39 |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: FACT-Lym Scores at Baseline and End of Treatment | End of Treatment, FACT-G Total Score | 79.2 scores on a scale | Standard Deviation 16.65 |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: FACT-Lym Scores at Baseline and End of Treatment | Baseline, FACT-Lymphoma Total Score | 127.7 scores on a scale | Standard Deviation 22.18 |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: FACT-Lym Scores at Baseline and End of Treatment | End of Treatment, FACT-Lymphoma Total Score | 127.8 scores on a scale | Standard Deviation 24.26 |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: FACT-Lym Scores at Baseline and End of Treatment | End of Treatment, FACT-Lymphoma Total Score | 125.2 scores on a scale | Standard Deviation 24.18 |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: FACT-Lym Scores at Baseline and End of Treatment | Baseline, PWB subscale | 24.1 scores on a scale | Standard Deviation 4.2 |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: FACT-Lym Scores at Baseline and End of Treatment | Baseline, FACT-LymS | 47.6 scores on a scale | Standard Deviation 7.98 |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: FACT-Lym Scores at Baseline and End of Treatment | End of Treatment, PWB subscale | 23.2 scores on a scale | Standard Deviation 5.21 |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: FACT-Lym Scores at Baseline and End of Treatment | Baseline, FACT-G Total Score | 79.7 scores on a scale | Standard Deviation 15.43 |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: FACT-Lym Scores at Baseline and End of Treatment | Baseline, SWB subscale | 20.2 scores on a scale | Standard Deviation 6.06 |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: FACT-Lym Scores at Baseline and End of Treatment | End of Treatment, FACT-LymS | 48.2 scores on a scale | Standard Deviation 8.71 |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: FACT-Lym Scores at Baseline and End of Treatment | End of Treatment, SWB subscale | 19.8 scores on a scale | Standard Deviation 5.34 |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: FACT-Lym Scores at Baseline and End of Treatment | Baseline, FACT-Lymphoma Total Score | 127.3 scores on a scale | Standard Deviation 21.57 |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: FACT-Lym Scores at Baseline and End of Treatment | Baseline, EWB subscale | 18.1 scores on a scale | Standard Deviation 4.12 |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: FACT-Lym Scores at Baseline and End of Treatment | Baseline, FACT-Lymphoma TOI | 89.0 scores on a scale | Standard Deviation 15.72 |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: FACT-Lym Scores at Baseline and End of Treatment | End of Treatment, EWB subscale | 18.1 scores on a scale | Standard Deviation 4.67 |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: FACT-Lym Scores at Baseline and End of Treatment | End of Treatment, FACT-G Total Score | 77.1 scores on a scale | Standard Deviation 16.8 |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: FACT-Lym Scores at Baseline and End of Treatment | Baseline, FWB subscale | 17.3 scores on a scale | Standard Deviation 6.08 |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: FACT-Lym Scores at Baseline and End of Treatment | End of Treatment, FACT-Lymphoma TOI | 87.4 scores on a scale | Standard Deviation 18.14 |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: FACT-Lym Scores at Baseline and End of Treatment | End of Treatment, FWB subscale | 16.2 scores on a scale | Standard Deviation 6.22 |
Secondary
Overall Population: Health State EQ-5D-5L Scores at Baseline and End of Treatment
The EQ-5D-5L contains a participant-reported score regarding health state measured on a visual analog scale (scores range from 0 \[worst imaginable health state\] to 100 \[best imaginable health state\]), and 5 questions on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The 5 questions have 5 response levels: 1, no problems; 2, slight problems; 3, moderate problems; 4, severe problems; and 5, unable to/extreme problems.
Time frame: up to approximately 34 months
Population: Overall Full Analysis Set. As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: Health State EQ-5D-5L Scores at Baseline and End of Treatment | Baseline | 72.2 scores on a scale | Standard Deviation 18.78 |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: Health State EQ-5D-5L Scores at Baseline and End of Treatment | End of Treatment | 74.2 scores on a scale | Standard Deviation 18.37 |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: Health State EQ-5D-5L Scores at Baseline and End of Treatment | Baseline | 72.6 scores on a scale | Standard Deviation 19.67 |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: Health State EQ-5D-5L Scores at Baseline and End of Treatment | End of Treatment | 72.0 scores on a scale | Standard Deviation 19.21 |
Secondary
Overall Population: Kaplan-Meier Estimates of DOR (the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by Investigator Assessment
PET, CR: (1) score of 1 (no uptake above background), 2 (uptake ≤ mediastinum), or 3 (uptake \> mediastinum but ≤ liver) with/without a residual mass for lymph nodes and extralymphatic sites (LN/ELS); (2) no evidence of FDG-avid disease in bone marrow; (3) no new lesions. PR: (1) score of 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) with reduced uptake compared with Baseline and residual mass(es) of any size for LN/ELS; (2) residual uptake higher than in normal bone marrow but reduced from Baseline; (3) no new lesions. CT, CR: (1) target nodes/nodal masses regressed to ≤1.5 cm in LDi. no extra lymphatic site of disease; (2) absent nontarget lesions; (3) liver/spleen regressed to normal; (4) bone marrow normal by morphology; (5) no new lesions. PR: (1) ≥50% decrease in SPD of up to 6 target measurable nodes and extranodal sites; (2) no increase in target lesions; (3) spleen regressed by \>50% in length beyond normal; (4) no new lesions.
Time frame: up to 2 years
Population: Overall Full Analysis Set. Per the SAP, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population (main analysis population). Participants who achieved CR or PR were analyzed. The number of participants analyzed for the Kaplan-Meier estimate at each time point refers to the total number of participants in the analysis set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: Kaplan-Meier Estimates of DOR (the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by Investigator Assessment | 12 months | 78.1 percent probability |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: Kaplan-Meier Estimates of DOR (the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by Investigator Assessment | 18 months | 66.6 percent probability |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: Kaplan-Meier Estimates of DOR (the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by Investigator Assessment | 2 years | 43.4 percent probability |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: Kaplan-Meier Estimates of DOR (the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by Investigator Assessment | 6 months | 90.8 percent probability |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: Kaplan-Meier Estimates of DOR (the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by Investigator Assessment | 6 months | 80.5 percent probability |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: Kaplan-Meier Estimates of DOR (the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by Investigator Assessment | 12 months | 64.4 percent probability |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: Kaplan-Meier Estimates of DOR (the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by Investigator Assessment | 2 years | 35.1 percent probability |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: Kaplan-Meier Estimates of DOR (the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by Investigator Assessment | 18 months | 47.6 percent probability |
p-value: 0.000395% CI: [0.397, 0.763]stratified Log Rank
Secondary
Overall Population: Kaplan-Meier Estimates of DOR (the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by IRC Review
PET, CR: (1) score of 1 (no uptake above background), 2 (uptake ≤ mediastinum), or 3 (uptake \> mediastinum but ≤ liver) with/without a residual mass for lymph nodes and extralymphatic sites (LN/ELS); (2) no evidence of FDG-avid disease in bone marrow; (3) no new lesions. PR: (1) score of 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) with reduced uptake compared with Baseline and residual mass(es) of any size for LN/ELS; (2) residual uptake higher than in normal bone marrow but reduced from Baseline; (3) no new lesions. CT, CR: (1) target nodes/nodal masses regressed to ≤1.5 cm in LDi. no extra lymphatic site of disease; (2) absent nontarget lesions; (3) liver/spleen regressed to normal; (4) bone marrow normal by morphology; (5) no new lesions. PR: (1) ≥50% decrease in SPD of up to 6 target measurable nodes and extranodal sites; (2) no increase in target lesions; (3) spleen regressed by \>50% in length beyond normal; (4) no new lesions.
Time frame: up to 2 years
Population: Overall Full Analysis Set. Per the SAP, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population (main analysis population). Participants who achieved CR or PR were analyzed. The number of participants analyzed for the Kaplan-Meier estimate at each time point refers to the total number of participants in the analysis set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: Kaplan-Meier Estimates of DOR (the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by IRC Review | 6 months | 93.1 percent probability |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: Kaplan-Meier Estimates of DOR (the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by IRC Review | 12 months | 80.0 percent probability |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: Kaplan-Meier Estimates of DOR (the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by IRC Review | 18 months | 65.7 percent probability |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: Kaplan-Meier Estimates of DOR (the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by IRC Review | 2 years | 56.0 percent probability |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: Kaplan-Meier Estimates of DOR (the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by IRC Review | 2 years | 40.9 percent probability |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: Kaplan-Meier Estimates of DOR (the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by IRC Review | 6 months | 81.5 percent probability |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: Kaplan-Meier Estimates of DOR (the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by IRC Review | 18 months | 56.5 percent probability |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: Kaplan-Meier Estimates of DOR (the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by IRC Review | 12 months | 65.6 percent probability |
p-value: 0.746995% CI: [0.409, 3.475]stratified Log Rank
Secondary
Overall Population: Kaplan-Meier Estimates of Overall Survival
Overall survival was defined as the time from randomization until death from any cause. Kaplan-Meier estimates indicate the percent probability of a participant being alive at the indicated time after treatment start.
Time frame: up to 2 years
Population: Overall Full Analysis Set. As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Censored participants were included in the analysis. The number of participants analyzed for the Kaplan-Meier estimate at each time point refers to the total number of participants in the analysis set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: Kaplan-Meier Estimates of Overall Survival | 6 months | 98.7 percent probability |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: Kaplan-Meier Estimates of Overall Survival | 2 months | 96.4 percent probability |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: Kaplan-Meier Estimates of Overall Survival | 18 months | 92.2 percent probability |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: Kaplan-Meier Estimates of Overall Survival | 2 years | 90.1 percent probability |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: Kaplan-Meier Estimates of Overall Survival | 2 years | 88.3 percent probability |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: Kaplan-Meier Estimates of Overall Survival | 6 months | 96.5 percent probability |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: Kaplan-Meier Estimates of Overall Survival | 18 months | 91.7 percent probability |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: Kaplan-Meier Estimates of Overall Survival | 2 months | 94.4 percent probability |
p-value: 0.583795% CI: [0.476, 1.519]stratified Log Rank
Secondary
Overall Population: Kaplan-Meier Estimates of PFS by Investigator Assessment, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First
PD, PET: score 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) for lymph node/extra lymphatic sites with increase in intensity of Baseline uptake and/or new FDG-avid foci consistent with lymphoma at interim/end-of-treatment assessment; new/recurrent FDG-avid foci in bone marrow; new FDG-avid foci consistent with lymphoma versus other etiology in new lesions. PD, CT: abnormal individual node/lesion with LDi \>1.5 cm and increase by ≥50% from the PPD nadir and increase in LDi or SDi from nadir; new/clear progression of preexisting nontarget lesions; new/recurrent splenomegaly and bone marrow involvement; regrowth of previously resolved lesions. New node \>1.5 cm in any axis. New extranodal site \>1.0 cm in any axis; if \<1.0 cm, presence is unequivocal and attributable to lymphoma. Kaplan-Meier estimates indicate the percent probability of a participant being alive at the indicated time after treatment start.
Time frame: up to 2 years
Population: Overall Full Analysis Set. As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Censored participants were included in the analysis. The number of participants analyzed for the Kaplan-Meier estimate at each time point refers to the total number of participants in the analysis set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: Kaplan-Meier Estimates of PFS by Investigator Assessment, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First | 12 months | 79.7 percent probability |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: Kaplan-Meier Estimates of PFS by Investigator Assessment, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First | 18 months | 64.1 percent probability |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: Kaplan-Meier Estimates of PFS by Investigator Assessment, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First | 2 years | 48.0 percent probability |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: Kaplan-Meier Estimates of PFS by Investigator Assessment, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First | 6 months | 92.7 percent probability |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: Kaplan-Meier Estimates of PFS by Investigator Assessment, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First | 2 years | 33.1 percent probability |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: Kaplan-Meier Estimates of PFS by Investigator Assessment, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First | 12 months | 58.7 percent probability |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: Kaplan-Meier Estimates of PFS by Investigator Assessment, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First | 6 months | 80.0 percent probability |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: Kaplan-Meier Estimates of PFS by Investigator Assessment, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First | 18 months | 44.7 percent probability |
p-value: <0.000195% CI: [0.383, 0.653]stratified Log Rank
Secondary
Overall Population: Kaplan-Meier Estimates of PFS by IRC Review, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First
PD, PET: score 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) for lymph node/extra lymphatic sites with increase in intensity of Baseline uptake and/or new FDG-avid foci consistent with lymphoma at interim/end-of-treatment assessment; new/recurrent FDG-avid foci in bone marrow; new FDG-avid foci consistent with lymphoma versus other etiology in new lesions. PD, CT: abnormal individual node/lesion with LDi \>1.5 cm and increase by ≥50% from the PPD nadir and increase in LDi or SDi from nadir; new/clear progression of preexisting nontarget lesions; new/recurrent splenomegaly and bone marrow involvement; regrowth of previously resolved lesions. New node \>1.5 cm in any axis. New extranodal site \>1.0 cm in any axis; if \<1.0 cm, presence is unequivocal and attributable to lymphoma. Kaplan-Meier estimates indicate the percent probability of a participant being alive at the indicated time after treatment start.
Time frame: up to 2 years
Population: Overall Full Analysis Set. As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Censored participants were included in the analysis. The number of participants analyzed for the Kaplan-Meier estimate at each time point refers to the total number of participants in the analysis set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: Kaplan-Meier Estimates of PFS by IRC Review, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First | 6 months | 93.9 percent probability |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: Kaplan-Meier Estimates of PFS by IRC Review, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First | 12 months | 84.5 percent probability |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: Kaplan-Meier Estimates of PFS by IRC Review, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First | 18 months | 68.9 percent probability |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: Kaplan-Meier Estimates of PFS by IRC Review, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First | 2 years | 56.0 percent probability |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: Kaplan-Meier Estimates of PFS by IRC Review, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First | 2 years | 38.8 percent probability |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: Kaplan-Meier Estimates of PFS by IRC Review, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First | 6 months | 82.5 percent probability |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: Kaplan-Meier Estimates of PFS by IRC Review, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First | 12 months | 63.7 percent probability |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: Kaplan-Meier Estimates of PFS by IRC Review, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First | 18 months | 52.0 percent probability |
p-value: <0.000195% CI: [0.357, 0.647]stratified Log Rank
Secondary
Overall Population: MRD-negativity Rate (at Threshold of 10-5) at End of Treatment
The MRD-negativity rate was defined as the percentage of participants who achieved a negative MRD result in peripheral blood at the End of Treatment. The threshold used for the analysis was 10\^-5 cells. MRD status was only analyzed with a threshold of ≤10\^-5 cells for MRD negativity. The Overall MRD Blood-Evaluable Set included all participants in the Full Analysis Set who received at least 1 dose of study treatment with identifiable clonality in blood samples at Cycle 1 Day 1.
Time frame: up to approximately 34 months
Population: Overall MRD Blood-Evaluable Set. As pre-specified in the Statistical Analysis Plan, the MZL population was a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. The 95% confidence intervals were calculated using the Clopper-Pearson method. Participants who did not have a post-baseline assessment were considered to be not assessed, but were included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: MRD-negativity Rate (at Threshold of 10-5) at End of Treatment | 21.6 percentage of participants |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: MRD-negativity Rate (at Threshold of 10-5) at End of Treatment | 15.1 percentage of participants |
p-value: 0.287495% CI: [0.69, 3.47]stratified Cochran-Mantel-Haenszel
Secondary
Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
The EQ-5D-5L contains a participant-reported score regarding health state measured on a visual analog scale (scores range from 0 \[worst imaginable health state\] to 100 \[best imaginable health state\]), and 5 questions on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The 5 questions have 5 response levels: 1, no problems; 2, slight problems; 3, moderate problems; 4, severe problems; and 5, unable to/extreme problems.
Time frame: up to approximately 34 months
Population: Overall Full Analysis Set. As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | End of Treatment, Self-care, Score 2 | 15 Participants |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | End of Treatment, Mobility, Score 1 | 149 Participants |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | End of Treatment, Mobility, Score 2 | 46 Participants |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | End of Treatment, Mobility, Score 3 | 17 Participants |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | End of Treatment, Mobility, Score 4 | 13 Participants |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | End of Treatment, Mobility, Score 5 | 3 Participants |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | Baseline, Self-care, Score 1 | 294 Participants |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | Baseline, Self-care, Score 2 | 12 Participants |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | Baseline, Self-care, Score 3 | 4 Participants |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | Baseline, Self-care, Score 4 | 2 Participants |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | Baseline, Self-care, Score 5 | 3 Participants |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | End of Treatment, Self-care, Score 1 | 198 Participants |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | Baseline, Mobility, Score 5 | 1 Participants |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | End of Treatment, Self-care, Score 3 | 9 Participants |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | End of Treatment, Self-care, Score 4 | 5 Participants |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | End of Treatment, Self-care, Score 5 | 1 Participants |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | Baseline, Usual Activities, Score 1 | 207 Participants |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | Baseline, Usual Activities, Score 2 | 74 Participants |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | Baseline, Usual Activities, Score 3 | 23 Participants |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | Baseline, Usual Activities, Score 4 | 6 Participants |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | Baseline, Usual Activities, Score 5 | 5 Participants |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | End of Treatment, Usual Activities, Score 1 | 133 Participants |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | End of Treatment, Usual Activities, Score 2 | 68 Participants |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | End of Treatment, Usual Activities, Score 3 | 15 Participants |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | End of Treatment, Usual Activities, Score 4 | 11 Participants |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | End of Treatment, Usual Activities, Score 5 | 1 Participants |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | Baseline, Pain/Discomfort, Score 1 | 168 Participants |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | Baseline, Pain/Discomfort, Score 2 | 108 Participants |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | Baseline, Pain/Discomfort, Score 3 | 35 Participants |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | Baseline, Pain/Discomfort, Score 4 | 3 Participants |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | Baseline, Pain/Discomfort, Score 5 | 1 Participants |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | End of Treatment, Pain/Discomfort, Score 1 | 129 Participants |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | End of Treatment, Pain/Discomfort, Score 2 | 68 Participants |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | End of Treatment, Pain/Discomfort, Score 3 | 21 Participants |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | End of Treatment, Pain/Discomfort, Score 4 | 10 Participants |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | End of Treatment, Pain/Discomfort, Score 5 | 0 Participants |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | Baseline, Anxiety/Depression, Score 1 | 173 Participants |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | Baseline, Anxiety/Depression, Score 2 | 110 Participants |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | Baseline, Anxiety/Depression, Score 3 | 25 Participants |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | Baseline, Anxiety/Depression, Score 4 | 6 Participants |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | Baseline, Anxiety/Depression, Score 5 | 1 Participants |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | End of Treatment, Anxiety/Depression, Score 1 | 136 Participants |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | End of Treatment, Anxiety/Depression, Score 2 | 68 Participants |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | End of Treatment, Anxiety/Depression, Score 3 | 20 Participants |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | End of Treatment, Anxiety/Depression, Score 4 | 2 Participants |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | End of Treatment, Anxiety/Depression, Score 5 | 2 Participants |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | Baseline, Mobility, Score 1 | 212 Participants |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | Baseline, Mobility, Score 2 | 68 Participants |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | Baseline, Mobility, Score 3 | 24 Participants |
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | Baseline, Mobility, Score 4 | 10 Participants |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | Baseline, Anxiety/Depression, Score 2 | 98 Participants |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | Baseline, Mobility, Score 5 | 0 Participants |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | End of Treatment, Usual Activities, Score 5 | 5 Participants |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | End of Treatment, Mobility, Score 1 | 149 Participants |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | Baseline, Mobility, Score 3 | 30 Participants |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | End of Treatment, Mobility, Score 2 | 47 Participants |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | Baseline, Pain/Discomfort, Score 1 | 161 Participants |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | End of Treatment, Mobility, Score 3 | 22 Participants |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | Baseline, Anxiety/Depression, Score 3 | 30 Participants |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | End of Treatment, Mobility, Score 4 | 10 Participants |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | Baseline, Pain/Discomfort, Score 2 | 104 Participants |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | End of Treatment, Mobility, Score 5 | 1 Participants |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | Baseline, Mobility, Score 2 | 47 Participants |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | Baseline, Self-care, Score 1 | 284 Participants |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | Baseline, Pain/Discomfort, Score 3 | 40 Participants |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | Baseline, Self-care, Score 2 | 22 Participants |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | Baseline, Anxiety/Depression, Score 4 | 8 Participants |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | Baseline, Self-care, Score 3 | 6 Participants |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | Baseline, Pain/Discomfort, Score 4 | 8 Participants |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | Baseline, Self-care, Score 4 | 1 Participants |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | End of Treatment, Anxiety/Depression, Score 5 | 0 Participants |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | Baseline, Self-care, Score 5 | 1 Participants |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | Baseline, Pain/Discomfort, Score 5 | 1 Participants |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | End of Treatment, Self-care, Score 1 | 202 Participants |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | Baseline, Anxiety/Depression, Score 5 | 1 Participants |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | End of Treatment, Self-care, Score 2 | 15 Participants |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | End of Treatment, Pain/Discomfort, Score 1 | 124 Participants |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | End of Treatment, Self-care, Score 3 | 7 Participants |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | End of Treatment, Anxiety/Depression, Score 4 | 5 Participants |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | End of Treatment, Self-care, Score 4 | 5 Participants |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | End of Treatment, Pain/Discomfort, Score 2 | 70 Participants |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | End of Treatment, Self-care, Score 5 | 0 Participants |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | End of Treatment, Anxiety/Depression, Score 1 | 126 Participants |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | Baseline, Usual Activities, Score 1 | 208 Participants |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | End of Treatment, Pain/Discomfort, Score 3 | 23 Participants |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | Baseline, Usual Activities, Score 2 | 64 Participants |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | Baseline, Mobility, Score 4 | 11 Participants |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | Baseline, Usual Activities, Score 3 | 33 Participants |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | End of Treatment, Pain/Discomfort, Score 4 | 9 Participants |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | Baseline, Usual Activities, Score 4 | 5 Participants |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | End of Treatment, Anxiety/Depression, Score 2 | 74 Participants |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | Baseline, Usual Activities, Score 5 | 4 Participants |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | End of Treatment, Pain/Discomfort, Score 5 | 3 Participants |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | End of Treatment, Usual Activities, Score 1 | 135 Participants |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | Baseline, Mobility, Score 1 | 226 Participants |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | End of Treatment, Usual Activities, Score 2 | 62 Participants |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | Baseline, Anxiety/Depression, Score 1 | 177 Participants |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | End of Treatment, Usual Activities, Score 3 | 21 Participants |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | End of Treatment, Anxiety/Depression, Score 3 | 24 Participants |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment | End of Treatment, Usual Activities, Score 4 | 6 Participants |
Secondary
Overall Population: Overall Response Rate (Percentage of Participants Who Achieved a CR/PR Per Lugano Classification at Any Time During the Study But Before the First PD and Before/at the Start of a New Antilymphoma Treatment) by Investigator Assessment
PET, CR: (1) score of 1 (no uptake above background), 2 (uptake ≤ mediastinum), or 3 (uptake \> mediastinum but ≤ liver) with/without a residual mass for lymph nodes and extralymphatic sites (LN/ELS); (2) no evidence of FDG-avid disease in bone marrow; (3) no new lesions. PR: (1) score of 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) with reduced uptake compared with Baseline and residual mass(es) of any size for LN/ELS; (2) residual uptake higher than in normal bone marrow but reduced from Baseline; (3) no new lesions. CT, CR: (1) target nodes/nodal masses regressed to ≤1.5 cm in LDi. no extra lymphatic site of disease; (2) absent nontarget lesions; (3) liver/spleen regressed to normal; (4) bone marrow normal by morphology; (5) no new lesions. PR: (1) ≥50% decrease in SPD of up to 6 target measurable nodes and extranodal sites; (2) no increase in target lesions; (3) spleen regressed by \>50% in length beyond normal; (4) no new lesions.
Time frame: up to approximately 34 months
Population: Overall Full Analysis Set. As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. The 95% confidence intervals were calculated using the Clopper-Pearson method.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: Overall Response Rate (Percentage of Participants Who Achieved a CR/PR Per Lugano Classification at Any Time During the Study But Before the First PD and Before/at the Start of a New Antilymphoma Treatment) by Investigator Assessment | 82.8 percentage of participants |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: Overall Response Rate (Percentage of Participants Who Achieved a CR/PR Per Lugano Classification at Any Time During the Study But Before the First PD and Before/at the Start of a New Antilymphoma Treatment) by Investigator Assessment | 72.0 percentage of participants |
p-value: 0.000995% CI: [1.29, 2.74]Cochran-Mantel-Haenszel
Secondary
Overall Population: Overall Response Rate (Percentage of Participants Who Achieved a CR/PR Per Lugano Classification at Any Time During the Study But Before the First PD and Before/at the Start of a New Antilymphoma Treatment) by IRC Review
PET, CR: (1) score of 1 (no uptake above background), 2 (uptake ≤ mediastinum), or 3 (uptake \> mediastinum but ≤ liver) with/without a residual mass for lymph nodes and extralymphatic sites (LN/ELS); (2) no evidence of FDG-avid disease in bone marrow; (3) no new lesions. PR: (1) score of 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) with reduced uptake compared with Baseline and residual mass(es) of any size for LN/ELS; (2) residual uptake higher than in normal bone marrow but reduced from Baseline; (3) no new lesions. CT, CR: (1) target nodes/nodal masses regressed to ≤1.5 cm in LDi. no extra lymphatic site of disease; (2) absent nontarget lesions; (3) liver/spleen regressed to normal; (4) bone marrow normal by morphology; (5) no new lesions. PR: (1) ≥50% decrease in SPD of up to 6 target measurable nodes and extranodal sites; (2) no increase in target lesions; (3) spleen regressed by \>50% in length beyond normal; (4) no new lesions.
Time frame: up to approximately 34 months
Population: Overall Full Analysis Set. As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. The 95% confidence intervals were calculated using the Clopper-Pearson method.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: Overall Response Rate (Percentage of Participants Who Achieved a CR/PR Per Lugano Classification at Any Time During the Study But Before the First PD and Before/at the Start of a New Antilymphoma Treatment) by IRC Review | 83.7 percentage of participants |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: Overall Response Rate (Percentage of Participants Who Achieved a CR/PR Per Lugano Classification at Any Time During the Study But Before the First PD and Before/at the Start of a New Antilymphoma Treatment) by IRC Review | 72.6 percentage of participants |
p-value: 0.000595% CI: [1.33, 2.86]stratified Cochran-Mantel-Haenszel
Secondary
Overall Population: Overall Survival
Overall survival was defined as the time from randomization until death from any cause.
Time frame: up to approximately 34 months
Population: Overall Full Analysis Set. As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. The 2-sided 95% confidence intervals were calculated using the method of Brookmeyer and Crowley with log-log transformation. Censored participants were included in the analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: Overall Survival | NA months |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: Overall Survival | NA months |
Secondary
Overall Population: PFS by Investigator Assessment, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First
PD, PET: score 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) for lymph node/extra lymphatic sites with increase in intensity of Baseline uptake and/or new FDG-avid foci consistent with lymphoma at interim/end-of-treatment assessment; new/recurrent FDG-avid foci in bone marrow; new FDG-avid foci consistent with lymphoma versus other etiology in new lesions. PD, CT: abnormal individual node/lesion with LDi \>1.5 cm and increase by ≥50% from the PPD nadir and increase in LDi or SDi from nadir; new/clear progression of preexisting nontarget lesions; new/recurrent splenomegaly and bone marrow involvement; regrowth of previously resolved lesions. New node \>1.5 cm in any axis. New extranodal site \>1.0 cm in any axis; if \<1.0 cm, presence is unequivocal and attributable to lymphoma.
Time frame: up to approximately 34 months
Population: Overall Full Analysis Set. As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. The 2-sided 95% confidence intervals were calculated using the method of Brookmeyer and Crowley with log-log transformation. Censored participants were included in the analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: PFS by Investigator Assessment, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First | 23.95 months |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: PFS by Investigator Assessment, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First | 16.39 months |
Secondary
Overall Population: PFS by IRC Review, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First
PD, PET: score 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) for lymph node/extra lymphatic sites with increase in intensity of Baseline uptake and/or new FDG-avid foci consistent with lymphoma at interim/end-of-treatment assessment; new/recurrent FDG-avid foci in bone marrow; new FDG-avid foci consistent with lymphoma versus other etiology in new lesions. PD, CT: abnormal individual node/lesion with LDi \>1.5 cm and increase by ≥50% from the PPD nadir and increase in LDi or SDi from nadir; new/clear progression of preexisting nontarget lesions; new/recurrent splenomegaly and bone marrow involvement; regrowth of previously resolved lesions. New node \>1.5 cm in any axis. New extranodal site \>1.0 cm in any axis; if \<1.0 cm, presence is unequivocal and attributable to lymphoma.
Time frame: up to approximately 34 months
Population: Overall Full Analysis Set. As pre-specified in the Statistical Analysis Plan, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population, which was a main analysis population. The 2-sided 95% confidence intervals were calculated using the method of Brookmeyer and Crowley with log-log transformation. Censored participants were included in the analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| FL: Tafasitamab + Rituximab + Lenalidomide | Overall Population: PFS by IRC Review, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First | NA months |
| FL: Placebo + Rituximab + Lenalidomide | Overall Population: PFS by IRC Review, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First | 20.73 months |