Skip to content
Triangle logo TriangleGet started
← Full study record

NCT04680052 · OUTCOME

FL Population: Kaplan-Meier Estimates of Overall Survival

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

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.

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 + Lenalidomide99.3Not reported97.199.8Not reported
FL: Placebo + Rituximab + Lenalidomide96.2Not reported93.198.0Not reported
12 months
Values in percent probability · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
FL: Tafasitamab + Rituximab + Lenalidomide96.4Not reported92.898.2Not reported
FL: Placebo + Rituximab + Lenalidomide93.7Not reported90.096.1Not reported
18 months
Values in percent probability · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
FL: Tafasitamab + Rituximab + Lenalidomide93.8Not reported89.196.5Not reported
FL: Placebo + Rituximab + Lenalidomide90.1Not reported84.893.6Not reported
2 years
Values in percent probability · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
FL: Tafasitamab + Rituximab + Lenalidomide92.5Not reported87.095.8Not reported
FL: Placebo + Rituximab + Lenalidomide85.5Not reported76.291.4Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.306
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.128
    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
    0.1061
    param Type
    Hazard Ratio (HR)
    param Value
    0.587
    statistical Method
    stratified Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.306
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.128
    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
    0.1061
    param Type
    Hazard Ratio (HR)
    param Value
    0.587
    statistical Method
    stratified Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        97.1
        upper Limit
        99.8
        value
        99.3
      2. group Id
        OG001
        lower Limit
        93.1
        upper Limit
        98.0
        value
        96.2
    title
    6 months
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        92.8
        upper Limit
        98.2
        value
        96.4
      2. group Id
        OG001
        lower Limit
        90.0
        upper Limit
        96.1
        value
        93.7
    title
    12 months
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        89.1
        upper Limit
        96.5
        value
        93.8
      2. group Id
        OG001
        lower Limit
        84.8
        upper Limit
        93.6
        value
        90.1
    title
    18 months
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        87.0
        upper Limit
        95.8
        value
        92.5
      2. group Id
        OG001
        lower Limit
        76.2
        upper Limit
        91.4
        value
        85.5
    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
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.
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 Overall Survival
type
SECONDARY
unit Of Measure
percent probability

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice