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NCT03332017 · OUTCOME

Overall Response Rate (ORR) by Independent Central Review (ICR) Assessment

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
NUMBER
Unit
percentage of participants
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

ORR was defined as the percentage of participants who achieved a best overall response of complete response (CR) or partial response (PR) per the Lugano Classification for Non-Hodgkin's Lymphoma.

Analysis population: Intent-To-Treat (ITT) analysis set includes all randomized participants.

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

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Obinutuzumab45.8Not reported34.058.0Not reported
Zanubrutinib + Obinutuzumab68.3Not reported60.075.7Not reported

Source statistical analyses

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

  1. ci Lower Limit
    8.3
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    35.8
    estimate Comment
    Mantel-Haenszel common risk difference was estimated by a normal approximation and Sato's variance estimator, stratified by rituximab-refractory status, number of prior lines of therapy, and geographic region.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0017
    param Type
    Risk Difference (RD)
    param Value
    22.0
    statistical Comment
    P-value was stratified by rituximab-refractory status, number of prior lines of therapy, and geographic region per interactive response technology.
    statistical Method
    Cochran-Mantel-Haenszel
Complete source fields
analyses
  1. ci Lower Limit
    8.3
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    35.8
    estimate Comment
    Mantel-Haenszel common risk difference was estimated by a normal approximation and Sato's variance estimator, stratified by rituximab-refractory status, number of prior lines of therapy, and geographic region.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0017
    param Type
    Risk Difference (RD)
    param Value
    22.0
    statistical Comment
    P-value was stratified by rituximab-refractory status, number of prior lines of therapy, and geographic region per interactive response technology.
    statistical Method
    Cochran-Mantel-Haenszel
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        34.0
        upper Limit
        58.0
        value
        45.8
      2. group Id
        OG001
        lower Limit
        60.0
        upper Limit
        75.7
        value
        68.3
denoms
  1. counts
    1. group Id
      OG000
      value
      72
    2. group Id
      OG001
      value
      145
    units
    Participants
description
ORR was defined as the percentage of participants who achieved a best overall response of complete response (CR) or partial response (PR) per the Lugano Classification for Non-Hodgkin's Lymphoma.
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
NUMBER
population Description
Intent-To-Treat (ITT) analysis set includes all randomized participants.
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
Overall Response Rate (ORR) by Independent Central Review (ICR) Assessment
type
PRIMARY
unit Of Measure
percentage of participants

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

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