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NCT02343120 · OUTCOME

Part 1 and Part 2: Progression-free Survival (PFS)

Study of the Safety and Pharmacokinetics of BGB-3111 in Subjects With B-Cell Lymphoid Malignancies · Source last updated 2022-04-28

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
Up to 6 years and 7 months

What was measured

PFS is defined as the time from the first dose date of study drug to the date of the earliest occurrence of progressive disease or death due to any cause, whichever occurs first. Efficacy results are reported for each of the B-cell malignancy subtypes: chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), Waldenström macroglobulinemia (WM), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL), Richter's Transformation (RT), and Hairy cell leukemia (HCL).

Analysis population: Efficacy Evaluable Set consists of all participants who received at least one dose of zanubrutinib; for WM, participants also must have a baseline IgM (or M-protein) ≥ 5 g/L and no prior exposure to a BTK inhibitor.

Groups in this outcome

Part 1 and Part 2: Overall

The dose regimens from Part 1 (40 mg, 80 mg, 160 mg QD, 160 mg BID and 320 mg QD) and Part 2 (160 mg BID and 320 mg QD) were evaluated in different disease types. Efficacy evaluations are reported by disease type for Parts 1 and 2 combined, as pre-specified in the statistical analysis plan.

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

Analysis denominator · Participants

GroupSource count
Part 1 and Part 2: Overall378

Reported measurements

CLL/SLL

Analysis denominator · Participants

GroupSource count
Part 1 and Part 2: Overall125
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Part 1 and Part 2: Overall61.4Not reported55.2NAData not estimable due to insufficient number of participants with events
WM

Analysis denominator · Participants

GroupSource count
Part 1 and Part 2: Overall73
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Part 1 and Part 2: OverallNANot reported48.9NAData not estimable due to insufficient number of participants with events
MCL

Analysis denominator · Participants

GroupSource count
Part 1 and Part 2: Overall57
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Part 1 and Part 2: Overall27.6Not reported15.445.5Not reported
MZL

Analysis denominator · Participants

GroupSource count
Part 1 and Part 2: Overall20
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Part 1 and Part 2: OverallNANot reported17.1NAData not estimable due to insufficient number of participants with events
FL

Analysis denominator · Participants

GroupSource count
Part 1 and Part 2: Overall33
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Part 1 and Part 2: Overall10.4Not reported7.722.9Not reported
DLBCL

Analysis denominator · Participants

GroupSource count
Part 1 and Part 2: Overall45
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Part 1 and Part 2: Overall4.1Not reported2.15.6Not reported
RT

Analysis denominator · Participants

GroupSource count
Part 1 and Part 2: Overall13
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Part 1 and Part 2: Overall17.3Not reported2.8NAData not estimable due to insufficient number of participants with events
HCL

Analysis denominator · Participants

GroupSource count
Part 1 and Part 2: Overall12
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Part 1 and Part 2: OverallNANot reported28.7NAData not estimable due to insufficient number of participants with events
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Data not estimable due to insufficient number of participants with events
        group Id
        OG000
        lower Limit
        55.2
        upper Limit
        NA
        value
        61.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        125
      units
      Participants
    title
    CLL/SLL
  2. categories
    1. measurements
      1. comment
        Data not estimable due to insufficient number of participants with events
        group Id
        OG000
        lower Limit
        48.9
        upper Limit
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        73
      units
      Participants
    title
    WM
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        15.4
        upper Limit
        45.5
        value
        27.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        57
      units
      Participants
    title
    MCL
  4. categories
    1. measurements
      1. comment
        Data not estimable due to insufficient number of participants with events
        group Id
        OG000
        lower Limit
        17.1
        upper Limit
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        20
      units
      Participants
    title
    MZL
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        7.7
        upper Limit
        22.9
        value
        10.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        33
      units
      Participants
    title
    FL
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.1
        upper Limit
        5.6
        value
        4.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        45
      units
      Participants
    title
    DLBCL
  7. categories
    1. measurements
      1. comment
        Data not estimable due to insufficient number of participants with events
        group Id
        OG000
        lower Limit
        2.8
        upper Limit
        NA
        value
        17.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        13
      units
      Participants
    title
    RT
  8. categories
    1. measurements
      1. comment
        Data not estimable due to insufficient number of participants with events
        group Id
        OG000
        lower Limit
        28.7
        upper Limit
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        12
      units
      Participants
    title
    HCL
denoms
  1. counts
    1. group Id
      OG000
      value
      378
    units
    Participants
description
PFS is defined as the time from the first dose date of study drug to the date of the earliest occurrence of progressive disease or death due to any cause, whichever occurs first. Efficacy results are reported for each of the B-cell malignancy subtypes: chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), Waldenström macroglobulinemia (WM), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL), Richter's Transformation (RT), and Hairy cell leukemia (HCL).
dispersion Type
95% Confidence Interval
groups
  1. description
    The dose regimens from Part 1 (40 mg, 80 mg, 160 mg QD, 160 mg BID and 320 mg QD) and Part 2 (160 mg BID and 320 mg QD) were evaluated in different disease types. Efficacy evaluations are reported by disease type for Parts 1 and 2 combined, as pre-specified in the statistical analysis plan.
    id
    OG000
    title
    Part 1 and Part 2: Overall
param Type
MEDIAN
population Description
Efficacy Evaluable Set consists of all participants who received at least one dose of zanubrutinib; for WM, participants also must have a baseline IgM (or M-protein) ≥ 5 g/L and no prior exposure to a BTK inhibitor.
reporting Status
POSTED
time Frame
Up to 6 years and 7 months
title
Part 1 and Part 2: Progression-free Survival (PFS)
type
SECONDARY
unit Of Measure
Months

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Preserved source evidence · Not medical advice