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NCT03332173 · OUTCOME

Major Response Rate (MRR) as Assessed by the Independent Review Committee

Study of BTK Inhibitor BGB-3111 in Chinese Subjects With Relapsed/Refractory Waldenström's Macroglobulinemia (WM) · Source last updated 2024-10-26

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
Up to approximately 1 year and 9 months

What was measured

MRR is defined as the percentage of participants who achieved complete response (CR) + very good partial response (VGPR) + partial response (PR), as assessed by an independent review committee according to modified Owen's criteria

Analysis population: Efficacy Analysis Set includes participants with confirmed Waldenström's macroglobulinemia based on central pathologic review among those who received at least one dose of study drug and with a baseline IgM (or M-protein) ≥ 5 g/L

Groups in this outcome

Zanubrutinib

Zanubrutinib 160 mg orally twice daily with or without food until progressive disease or intolerable toxicity

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Zanubrutinib43

Reported measurements

Source class 1
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Zanubrutinib69.8Not reported53.8782.82Not reported

Source statistical analyses

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

  1. group Description
    Zanubrutinib versus historical control estimate of 30%
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    p Value Comment
    P value was based on the exact binomial test against the null hypothesis H0: MRR = 0.30 at a significance level of 0.025 (1-sided)
    statistical Method
    Exact binomial test
Complete source fields
analyses
  1. group Description
    Zanubrutinib versus historical control estimate of 30%
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    p Value Comment
    P value was based on the exact binomial test against the null hypothesis H0: MRR = 0.30 at a significance level of 0.025 (1-sided)
    statistical Method
    Exact binomial test
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        53.87
        upper Limit
        82.82
        value
        69.8
denoms
  1. counts
    1. group Id
      OG000
      value
      43
    units
    Participants
description
MRR is defined as the percentage of participants who achieved complete response (CR) + very good partial response (VGPR) + partial response (PR), as assessed by an independent review committee according to modified Owen's criteria
dispersion Type
95% Confidence Interval
groups
  1. description
    Zanubrutinib 160 mg orally twice daily with or without food until progressive disease or intolerable toxicity
    id
    OG000
    title
    Zanubrutinib
param Type
NUMBER
population Description
Efficacy Analysis Set includes participants with confirmed Waldenström's macroglobulinemia based on central pathologic review among those who received at least one dose of study drug and with a baseline IgM (or M-protein) ≥ 5 g/L
reporting Status
POSTED
time Frame
Up to approximately 1 year and 9 months
title
Major Response Rate (MRR) as Assessed by the Independent Review Committee
type
PRIMARY
unit Of Measure
Percentage of participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice