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NCT04680052 · OUTCOME

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

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: 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.

Groups in this outcome

FL and MZL: Tafasitamab + Rituximab + Lenalidomide

Participants with FL and 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.

FL and MZL: Placebo + Rituximab + Lenalidomide

Participants with FL and 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 and MZL: Tafasitamab + Rituximab + Lenalidomide326
FL and MZL: Placebo + Rituximab + Lenalidomide328

Reported measurements

6 months
Values in percent probability · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
FL and MZL: Tafasitamab + Rituximab + Lenalidomide93.9Not reported90.496.1Not reported
FL and MZL: Placebo + Rituximab + Lenalidomide82.5Not reported77.786.4Not reported
12 months
Values in percent probability · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
FL and MZL: Tafasitamab + Rituximab + Lenalidomide84.5Not reported79.288.5Not reported
FL and MZL: Placebo + Rituximab + Lenalidomide63.7Not reported57.569.3Not reported
18 months
Values in percent probability · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
FL and MZL: Tafasitamab + Rituximab + Lenalidomide68.9Not reported61.175.4Not reported
FL and MZL: Placebo + Rituximab + Lenalidomide52.0Not reported44.559.0Not reported
2 years
Values in percent probability · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
FL and MZL: Tafasitamab + Rituximab + Lenalidomide56.0Not reported45.165.6Not reported
FL and MZL: Placebo + Rituximab + Lenalidomide38.8Not reported28.349.1Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.357
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.647
    estimate Comment
    The hazard ratio was estimated using a stratified Cox proportional hazards model.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Only primary and key secondary endpoints were formally tested; this endpoint was not formally tested.
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    param Type
    Hazard Ratio (HR)
    param Value
    0.481
    statistical Method
    stratified Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.357
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.647
    estimate Comment
    The hazard ratio was estimated using a stratified Cox proportional hazards model.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Only primary and key secondary endpoints were formally tested; this endpoint was not formally tested.
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    param Type
    Hazard Ratio (HR)
    param Value
    0.481
    statistical Method
    stratified Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        90.4
        upper Limit
        96.1
        value
        93.9
      2. group Id
        OG001
        lower Limit
        77.7
        upper Limit
        86.4
        value
        82.5
    title
    6 months
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        79.2
        upper Limit
        88.5
        value
        84.5
      2. group Id
        OG001
        lower Limit
        57.5
        upper Limit
        69.3
        value
        63.7
    title
    12 months
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        61.1
        upper Limit
        75.4
        value
        68.9
      2. group Id
        OG001
        lower Limit
        44.5
        upper Limit
        59.0
        value
        52.0
    title
    18 months
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        45.1
        upper Limit
        65.6
        value
        56.0
      2. group Id
        OG001
        lower Limit
        28.3
        upper Limit
        49.1
        value
        38.8
    title
    2 years
denoms
  1. counts
    1. group Id
      OG000
      value
      326
    2. group Id
      OG001
      value
      328
    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 FL and 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
    OG000
    title
    FL and MZL: Tafasitamab + Rituximab + Lenalidomide
  2. description
    Participants with FL and 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
    OG001
    title
    FL and MZL: Placebo + Rituximab + Lenalidomide
param Type
NUMBER
population Description
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.
reporting Status
POSTED
time Frame
up to 2 years
title
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
type
SECONDARY
unit Of Measure
percent probability

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Preserved source evidence · Not medical advice