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NCT02343120 · OUTCOME

Part 1 and Part 2: Overall Response Rate (ORR)

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
NUMBER
Unit
Percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
Up to 6 years and 7 months

What was measured

ORR is defined as the percentage of participants with partial or complete response (CR), as assessed by the investigator. For CLL/SLL, ORR includes partial response (PR) with lymphocytosis (PR-L) or better (includes PR-L, PR, nodular PR or nPR and CR with incomplete marrow recovery or CRi) and for MW, ORR includes minor response or better. 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 Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Part 1 and Part 2: Overall95.2Not reported89.898.2Not reported
WM

Analysis denominator · Participants

GroupSource count
Part 1 and Part 2: Overall73
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Part 1 and Part 2: Overall95.9Not reported88.599.1Not reported
MCL

Analysis denominator · Participants

GroupSource count
Part 1 and Part 2: Overall57
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Part 1 and Part 2: Overall82.5Not reported70.191.3Not reported
MZL

Analysis denominator · Participants

GroupSource count
Part 1 and Part 2: Overall20
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Part 1 and Part 2: Overall85.0Not reported62.196.8Not reported
FL

Analysis denominator · Participants

GroupSource count
Part 1 and Part 2: Overall33
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Part 1 and Part 2: Overall36.4Not reported20.454.9Not reported
DLBCL

Analysis denominator · Participants

GroupSource count
Part 1 and Part 2: Overall45
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Part 1 and Part 2: Overall42.2Not reported27.757.8Not reported
RT

Analysis denominator · Participants

GroupSource count
Part 1 and Part 2: Overall13
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Part 1 and Part 2: Overall61.5Not reported31.686.1Not reported
HCL

Analysis denominator · Participants

GroupSource count
Part 1 and Part 2: Overall12
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Part 1 and Part 2: Overall58.3Not reported27.784.8Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        89.8
        upper Limit
        98.2
        value
        95.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        125
      units
      Participants
    title
    CLL/SLL
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        88.5
        upper Limit
        99.1
        value
        95.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        73
      units
      Participants
    title
    WM
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        70.1
        upper Limit
        91.3
        value
        82.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        57
      units
      Participants
    title
    MCL
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        62.1
        upper Limit
        96.8
        value
        85.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        20
      units
      Participants
    title
    MZL
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        20.4
        upper Limit
        54.9
        value
        36.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        33
      units
      Participants
    title
    FL
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        27.7
        upper Limit
        57.8
        value
        42.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        45
      units
      Participants
    title
    DLBCL
  7. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        31.6
        upper Limit
        86.1
        value
        61.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        13
      units
      Participants
    title
    RT
  8. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        27.7
        upper Limit
        84.8
        value
        58.3
    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
ORR is defined as the percentage of participants with partial or complete response (CR), as assessed by the investigator. For CLL/SLL, ORR includes partial response (PR) with lymphocytosis (PR-L) or better (includes PR-L, PR, nodular PR or nPR and CR with incomplete marrow recovery or CRi) and for MW, ORR includes minor response or better. 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
NUMBER
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: Overall Response Rate (ORR)
type
SECONDARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice