NCT04680052 · OUTCOME

Overall 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: 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

Group	Source count
FL and MZL: Tafasitamab + Rituximab + Lenalidomide	326
FL and MZL: Placebo + Rituximab + Lenalidomide	328

Reported measurements

6 months

Values in percent probability · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
FL and MZL: Tafasitamab + Rituximab + Lenalidomide	98.7	Not reported	96.7	99.5	Not reported
FL and MZL: Placebo + Rituximab + Lenalidomide	96.5	Not reported	93.8	98.1	Not reported

2 months

Values in percent probability · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
FL and MZL: Tafasitamab + Rituximab + Lenalidomide	96.4	Not reported	93.4	98.1	Not reported
FL and MZL: Placebo + Rituximab + Lenalidomide	94.4	Not reported	91.2	96.5	Not reported

18 months

Values in percent probability · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
FL and MZL: Tafasitamab + Rituximab + Lenalidomide	92.2	Not reported	87.7	95.1	Not reported
FL and MZL: Placebo + Rituximab + Lenalidomide	91.7	Not reported	87.4	94.5	Not reported

2 years

Values in percent probability · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
FL and MZL: Tafasitamab + Rituximab + Lenalidomide	90.1	Not reported	84.4	93.7	Not reported
FL and MZL: Placebo + Rituximab + Lenalidomide	88.3	Not reported	81.1	92.8	Not reported

Source statistical analyses

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

ci Lower Limit
0.476
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.519
estimate Comment
The hazard ratio was estimated using a stratified Cox proportional hazards model.
group Ids
OG000
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
0.5837
param Type
Hazard Ratio (HR)
param Value
0.850
statistical Method
stratified Log Rank

Complete source fields

analyses

ci Lower Limit
0.476
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.519
estimate Comment
The hazard ratio was estimated using a stratified Cox proportional hazards model.
group Ids
OG000
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
0.5837
param Type
Hazard Ratio (HR)
param Value
0.850
statistical Method
stratified Log Rank

classes

categories
measurements
group Id
OG000
lower Limit
96.7
upper Limit
99.5
value
98.7
group Id
OG001
lower Limit
93.8
upper Limit
98.1
value
96.5
title
6 months
categories
measurements
group Id
OG000
lower Limit
93.4
upper Limit
98.1
value
96.4
group Id
OG001
lower Limit
91.2
upper Limit
96.5
value
94.4
title
2 months
categories
measurements
group Id
OG000
lower Limit
87.7
upper Limit
95.1
value
92.2
group Id
OG001
lower Limit
87.4
upper Limit
94.5
value
91.7
title
18 months
categories
measurements
group Id
OG000
lower Limit
84.4
upper Limit
93.7
value
90.1
group Id
OG001
lower Limit
81.1
upper Limit
92.8
value
88.3
title
2 years

denoms

counts
group Id
OG000
value
326
group Id
OG001
value
328
units
Participants

description

dispersion Type

95% Confidence Interval

groups

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
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 Overall Survival

type

SECONDARY

unit Of Measure

percent probability

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Preserved source evidence · Not medical advice