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NCT03332017 · OUTCOME

Progression-free Survival (PFS)

A Study Comparing Obinutuzumab and BGB-3111 Versus Obinutuzumab Alone in Treating R/R Follicular Lymphoma · Source last updated 2026-02-18

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 first dose to primary analysis data cutoff (08OCT2021) start of a new anticancer therapy, or the crossover date, whichever came first. Median follow-up was 12.45 months.

What was measured

PFS was defined as the time from randomization to the date of first documented disease progression or death from any cause, whichever occurred first, as determined by the ICR or investigator assessment. For participants in the monotherapy arm who crossed over to combination therapy, disease assessments after crossover were not included in the PFS calculation. Median PFS was estimated using the Kaplan-Meier method.

Analysis population: ITT Analysis Set

Groups in this outcome

Obinutuzumab

Obinutuzumab 1000 milligrams (mg) intravenously on Days 1, 8, and 15 of Cycle 1, Day 1 of Cycles 2 to 6; and then every 8 weeks for an additional 24 months or until disease progression. Each treatment cycle was 28 days.

Zanubrutinib + Obinutuzumab

Zanubrutinib 160 mg twice a day orally with or without food and obinutuzumab 1000 mg intravenously on Days 1, 8, and 15 of Cycle 1, Day 1 of Cycles 2 to 6, and then every 8 weeks for an additional 24 months or until disease progression. Each treatment cycle was 28 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
Obinutuzumab72
Zanubrutinib + Obinutuzumab145

Reported measurements

ICR
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Obinutuzumab11.2Not reported6.515.7Not reported
Zanubrutinib + Obinutuzumab27.4Not reported16.1NANot estimable due to insufficient number of participants with events
Investigator
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Obinutuzumab5.8Not reported3.78.2Not reported
Zanubrutinib + Obinutuzumab22.2Not reported11.3NANot estimable due to insufficient number of participants with events

Source statistical analyses

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

  1. ci Lower Limit
    0.31
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.69
    estimate Comment
    The hazard ratio was estimated from a stratified Cox regression model stratified by rituximab-refractory status, number of prior lines of therapy and geographic region.
    group Description
    For Investigator Assessment
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    The two-sided significance threshold was set at α = 0.05.
    non Inferiority Type
    OTHER
    p Value
    0.0001
    param Type
    Hazard Ratio (HR)
    param Value
    0.47
    statistical Comment
    The p-value was stratified by rituximab-refractory status, number of prior lines of therapy and geographic region.
    statistical Method
    Log Rank
  2. ci Lower Limit
    0.32
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.81
    estimate Comment
    The hazard ratio was estimated from a stratified Cox regression model stratified by rituximab-refractory status, number of prior lines of therapy and geographic region.
    group Description
    For ICR Assessment
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    p Value
    0.0040
    param Type
    Hazard Ratio (HR)
    param Value
    0.51
    statistical Comment
    The p-value was stratified by rituximab-refractory status, number of prior lines of therapy and geographic region.
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.31
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.69
    estimate Comment
    The hazard ratio was estimated from a stratified Cox regression model stratified by rituximab-refractory status, number of prior lines of therapy and geographic region.
    group Description
    For Investigator Assessment
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    The two-sided significance threshold was set at α = 0.05.
    non Inferiority Type
    OTHER
    p Value
    0.0001
    param Type
    Hazard Ratio (HR)
    param Value
    0.47
    statistical Comment
    The p-value was stratified by rituximab-refractory status, number of prior lines of therapy and geographic region.
    statistical Method
    Log Rank
  2. ci Lower Limit
    0.32
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.81
    estimate Comment
    The hazard ratio was estimated from a stratified Cox regression model stratified by rituximab-refractory status, number of prior lines of therapy and geographic region.
    group Description
    For ICR Assessment
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    p Value
    0.0040
    param Type
    Hazard Ratio (HR)
    param Value
    0.51
    statistical Comment
    The p-value was stratified by rituximab-refractory status, number of prior lines of therapy and geographic region.
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        6.5
        upper Limit
        15.7
        value
        11.2
      2. comment
        Not estimable due to insufficient number of participants with events
        group Id
        OG001
        lower Limit
        16.1
        upper Limit
        NA
        value
        27.4
    title
    ICR
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3.7
        upper Limit
        8.2
        value
        5.8
      2. comment
        Not estimable due to insufficient number of participants with events
        group Id
        OG001
        lower Limit
        11.3
        upper Limit
        NA
        value
        22.2
    title
    Investigator
denoms
  1. counts
    1. group Id
      OG000
      value
      72
    2. group Id
      OG001
      value
      145
    units
    Participants
description
PFS was defined as the time from randomization to the date of first documented disease progression or death from any cause, whichever occurred first, as determined by the ICR or investigator assessment. For participants in the monotherapy arm who crossed over to combination therapy, disease assessments after crossover were not included in the PFS calculation. Median PFS was estimated using the Kaplan-Meier method.
dispersion Type
95% Confidence Interval
groups
  1. description
    Obinutuzumab 1000 milligrams (mg) intravenously on Days 1, 8, and 15 of Cycle 1, Day 1 of Cycles 2 to 6; and then every 8 weeks for an additional 24 months or until disease progression. Each treatment cycle was 28 days.
    id
    OG000
    title
    Obinutuzumab
  2. description
    Zanubrutinib 160 mg twice a day orally with or without food and obinutuzumab 1000 mg intravenously on Days 1, 8, and 15 of Cycle 1, Day 1 of Cycles 2 to 6, and then every 8 weeks for an additional 24 months or until disease progression. Each treatment cycle was 28 days.
    id
    OG001
    title
    Zanubrutinib + Obinutuzumab
param Type
MEDIAN
population Description
ITT Analysis Set
reporting Status
POSTED
time Frame
From first dose to primary analysis data cutoff (08OCT2021) start of a new anticancer therapy, or the crossover date, whichever came first. Median follow-up was 12.45 months.
title
Progression-free Survival (PFS)
type
SECONDARY
unit Of Measure
Months

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Preserved source evidence · Independent clinical review pending · Not medical advice