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NCT04680052 · OUTCOME

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

A Phase 3 Study to Assess Efficacy and Safety of Tafasitamab Plus Lenalidomide and Rituximab Compared to Placebo Plus Lenalidomide and Rituximab in Patients With Relapsed/Refractory (R/R) Follicular Lymphoma or Marginal Zone Lymphoma. · Source last updated 2026-09-04

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
percent probability
Interval / dispersion
95% Confidence Interval
Time frame
up to 2 years

What was measured

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.

Analysis 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.

Groups in this outcome

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.

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.

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.

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.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
FL: Tafasitamab + Rituximab + Lenalidomide273
FL: Placebo + Rituximab + Lenalidomide275
MZL: Tafasitamab + Rituximab + Lenalidomide0
MZL: Placebo + Rituximab + Lenalidomide0

Reported measurements

6 months
Values in percent probability · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
FL: Tafasitamab + Rituximab + Lenalidomide92.4Not reported88.395.1Not reported
FL: Placebo + Rituximab + Lenalidomide78.2Not reported72.782.7Not reported
12 months
Values in percent probability · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
FL: Tafasitamab + Rituximab + Lenalidomide79.0Not reported72.884.0Not reported
FL: Placebo + Rituximab + Lenalidomide54.0Not reported47.160.5Not reported
18 months
Values in percent probability · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
FL: Tafasitamab + Rituximab + Lenalidomide61.9Not reported53.469.3Not reported
FL: Placebo + Rituximab + Lenalidomide38.5Not reported30.846.1Not reported
2 years
Values in percent probability · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
FL: Tafasitamab + Rituximab + Lenalidomide41.7Not reported28.454.6Not reported
FL: Placebo + Rituximab + Lenalidomide31.8Not reported23.640.2Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    0.324
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.580
    estimate Comment
    The hazard ratio was estimated using a stratified Cox proportional hazards model.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    param Type
    Hazard Ratio (HR)
    param Value
    0.434
    statistical Method
    stratified Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.324
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.580
    estimate Comment
    The hazard ratio was estimated using a stratified Cox proportional hazards model.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    param Type
    Hazard Ratio (HR)
    param Value
    0.434
    statistical Method
    stratified Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        88.3
        upper Limit
        95.1
        value
        92.4
      2. group Id
        OG001
        lower Limit
        72.7
        upper Limit
        82.7
        value
        78.2
    title
    6 months
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        72.8
        upper Limit
        84.0
        value
        79.0
      2. group Id
        OG001
        lower Limit
        47.1
        upper Limit
        60.5
        value
        54.0
    title
    12 months
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        53.4
        upper Limit
        69.3
        value
        61.9
      2. group Id
        OG001
        lower Limit
        30.8
        upper Limit
        46.1
        value
        38.5
    title
    18 months
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        28.4
        upper Limit
        54.6
        value
        41.7
      2. group Id
        OG001
        lower Limit
        23.6
        upper Limit
        40.2
        value
        31.8
    title
    2 years
denoms
  1. counts
    1. group Id
      OG000
      value
      273
    2. group Id
      OG001
      value
      275
    3. group Id
      OG002
      value
      0
    4. group Id
      OG003
      value
      0
    units
    Participants
description
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.
dispersion Type
95% Confidence Interval
groups
  1. description
    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.
    id
    OG000
    title
    FL: Tafasitamab + Rituximab + Lenalidomide
  2. description
    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.
    id
    OG001
    title
    FL: Placebo + Rituximab + Lenalidomide
  3. description
    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.
    id
    OG002
    title
    MZL: Tafasitamab + Rituximab + Lenalidomide
  4. description
    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.
    id
    OG003
    title
    MZL: Placebo + Rituximab + Lenalidomide
param Type
NUMBER
population Description
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.
reporting Status
POSTED
time Frame
up to 2 years
title
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
type
PRIMARY
unit Of Measure
percent probability

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Preserved source evidence · Not medical advice