NCT03734016 · OUTCOME

Progression-free Survival Assessed by the Independent Review Committee

A Study of Zanubrutinib (BGB-3111) Versus Ibrutinib in Participants With Relapsed/Refractory Chronic Lymphocytic Leukemia · Source last updated 2025-03-30

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

Measure: MEDIAN
Unit: months
Interval / dispersion: 95% Confidence Interval
Time frame: From randomization to the final efficacy analysis cutoff date of 08 August 2022, median time on follow-up was 29.6 months (maximum of 45.2 months).

What was measured

PFS is defined as the time from randomization to the date of first documentation of disease progression or death, whichever occurred first. Median PFS was estimated using the Kaplan-Meier method.

Analysis population: Intent To Treat Analysis Set

Groups in this outcome

Zanubrutinib

Participants received 160 mg zanubrutinib orally twice daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.

Ibrutinib

Participants received ibrutinib 420 mg orally once daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.

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
Zanubrutinib	327
Ibrutinib	325

Reported measurements

Source class 1

Values in months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Zanubrutinib	NA	Not reported	34.3	NA	Insufficient number of participants with events to estimate median and upper 95% confidence limit.
Ibrutinib	35.0	Not reported	33.2	44.3	Not reported

Source statistical analyses

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

ci Lower Limit
0.49
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.86
estimate Comment
Hazard ratio is the ratio of the hazard of the zanubrutinib arm divided by that of the ibrutinib arm.
group Ids
OG000
OG001
non Inferiority Comment
Noninferiority was tested with a noninferiority margin (hazard ratio) of 1.33 with the use of a stratified Wald test based on the four randomization stratification factors.
non Inferiority Type
NON_INFERIORITY
p Value
<0.0001
p Value Comment
Stratified by the randomization stratification factors (age, geographic region, refractory status, and 17p deletion and TP53 mutation status)
param Type
Hazard Ratio (HR)
param Value
0.65
statistical Method
Stratified Wald test
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.0024
statistical Comment
Stratified by the randomization stratification factors (age, geographic region, refractory status, and 17p deletion and TP53 mutation status)
statistical Method
Stratified Log-rank test

Complete source fields

analyses

ci Lower Limit
0.49
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.86
estimate Comment
Hazard ratio is the ratio of the hazard of the zanubrutinib arm divided by that of the ibrutinib arm.
group Ids
OG000
OG001
non Inferiority Comment
Noninferiority was tested with a noninferiority margin (hazard ratio) of 1.33 with the use of a stratified Wald test based on the four randomization stratification factors.
non Inferiority Type
NON_INFERIORITY
p Value
<0.0001
p Value Comment
Stratified by the randomization stratification factors (age, geographic region, refractory status, and 17p deletion and TP53 mutation status)
param Type
Hazard Ratio (HR)
param Value
0.65
statistical Method
Stratified Wald test
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.0024
statistical Comment
Stratified by the randomization stratification factors (age, geographic region, refractory status, and 17p deletion and TP53 mutation status)
statistical Method
Stratified Log-rank test

classes

categories
measurements
comment
Insufficient number of participants with events to estimate median and upper 95% confidence limit.
group Id
OG000
lower Limit
34.3
upper Limit
NA
value
NA
group Id
OG001
lower Limit
33.2
upper Limit
44.3
value
35.0

denoms

counts
group Id
OG000
value
327
group Id
OG001
value
325
units
Participants

description

PFS is defined as the time from randomization to the date of first documentation of disease progression or death, whichever occurred first. Median PFS was estimated using the Kaplan-Meier method.

dispersion Type

95% Confidence Interval

groups

description
Participants received 160 mg zanubrutinib orally twice daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.
id
OG000
title
Zanubrutinib
description
Participants received ibrutinib 420 mg orally once daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.
id
OG001
title
Ibrutinib

param Type

MEDIAN

population Description

Intent To Treat Analysis Set

reporting Status

POSTED

time Frame

From randomization to the final efficacy analysis cutoff date of 08 August 2022, median time on follow-up was 29.6 months (maximum of 45.2 months).

title

Progression-free Survival Assessed by the Independent Review Committee

type

SECONDARY

unit Of Measure

months

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Preserved source evidence · Not medical advice