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NCT02737501 · OUTCOME

Intracranial Progression Free Survival

ALTA-1L Study: A Study of Brigatinib Versus Crizotinib in Anaplastic Lymphoma Kinase Positive (ALK+) Advanced Non-small Cell Lung Cancer (NSCLC) Participants · Source last updated 2021-08-20

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
Baseline up to end of study (Up to 56 months)

What was measured

Intracranial PFS as assessed by BIRC, is defined as the time from randomization until first CNS PD is documented, or death due to any cause. PD is SLD increased by at least 20% from the smallest value on study (including baseline, if that is the smallest), the SLD must also demonstrate an absolute increase of at least 5 mm, and unequivocal progression of existing non-target lesions.

Analysis population: ITT Population included all participants randomized to each regimen regardless of whether they tested ALK+, or whether they received study drug or adhered to the assigned dose. Overall number of participants analyzed are the participants with data available for analyses.

Groups in this outcome

Randomized Phase: Brigatinib 90 mg QD/180 QD

Brigatinib 90 mg, tablets, orally, QD for first 7 days followed by 180 mg, orally, QD, in each 28-day cycle until PD, intolerable toxicity, consent withdrawal, or death (The median duration of exposure was 34.86 months).

Randomized Phase: Crizotinib 250 mg BID

Crizotinib 250 mg, tablets, BID in each 28-day cycle until disease progression, intolerable toxicity, consent withdrawal, or death (The median duration of exposure was 9.26 months).

Crossover Phase: Brigatinib 90 mg QD/180 mg QD

Participants who experienced PD as assessed by the BIRC or received radiotherapy to the brain while on 'Crizotinib 250 mg BID' therapy in Randomized Phase were crossed over. Following 10-day washout period, crossover participants received brigatinib 90 mg, tablets, orally, QD for first 7 days followed by 180 mg, tablets, orally, QD in each 28-day cycle up to end of the study (The median duration of exposure was 17.25 months).

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

Analysis denominator · Participants

GroupSource count
Randomized Phase: Brigatinib 90 mg QD/180 QD47
Randomized Phase: Crizotinib 250 mg BID49
Crossover Phase: Brigatinib 90 mg QD/180 mg QD42

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Randomized Phase: Brigatinib 90 mg QD/180 QD23.951Not reported12.9130.78Not reported
Randomized Phase: Crizotinib 250 mg BID5.520Not reported3.717.52Not reported
Crossover Phase: Brigatinib 90 mg QD/180 mg QD24.542Not reported12.58NAUpper limit of 95% confidence interval (CI) was not estimable due to low 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
    0.17
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.51
    estimate Comment
    The hazard ratio was obtained using a Cox proportional hazards model with prior chemotherapy for locally advanced or metastatic disease (current strata) as covariate.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    p Value Comment
    P-values are from a log-rank test stratified by randomization stratification factors (current; presence of iCNS metastases at baseline and prior chemotherapy for locally advanced or metastatic disease).
    param Type
    Hazard Ratio (HR)
    param Value
    0.293
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.17
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.51
    estimate Comment
    The hazard ratio was obtained using a Cox proportional hazards model with prior chemotherapy for locally advanced or metastatic disease (current strata) as covariate.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    p Value Comment
    P-values are from a log-rank test stratified by randomization stratification factors (current; presence of iCNS metastases at baseline and prior chemotherapy for locally advanced or metastatic disease).
    param Type
    Hazard Ratio (HR)
    param Value
    0.293
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        12.91
        upper Limit
        30.78
        value
        23.951
      2. group Id
        OG001
        lower Limit
        3.71
        upper Limit
        7.52
        value
        5.520
      3. comment
        Upper limit of 95% confidence interval (CI) was not estimable due to low number of participants with events.
        group Id
        OG002
        lower Limit
        12.58
        upper Limit
        NA
        value
        24.542
denoms
  1. counts
    1. group Id
      OG000
      value
      47
    2. group Id
      OG001
      value
      49
    3. group Id
      OG002
      value
      42
    units
    Participants
description
Intracranial PFS as assessed by BIRC, is defined as the time from randomization until first CNS PD is documented, or death due to any cause. PD is SLD increased by at least 20% from the smallest value on study (including baseline, if that is the smallest), the SLD must also demonstrate an absolute increase of at least 5 mm, and unequivocal progression of existing non-target lesions.
dispersion Type
95% Confidence Interval
groups
  1. description
    Brigatinib 90 mg, tablets, orally, QD for first 7 days followed by 180 mg, orally, QD, in each 28-day cycle until PD, intolerable toxicity, consent withdrawal, or death (The median duration of exposure was 34.86 months).
    id
    OG000
    title
    Randomized Phase: Brigatinib 90 mg QD/180 QD
  2. description
    Crizotinib 250 mg, tablets, BID in each 28-day cycle until disease progression, intolerable toxicity, consent withdrawal, or death (The median duration of exposure was 9.26 months).
    id
    OG001
    title
    Randomized Phase: Crizotinib 250 mg BID
  3. description
    Participants who experienced PD as assessed by the BIRC or received radiotherapy to the brain while on 'Crizotinib 250 mg BID' therapy in Randomized Phase were crossed over. Following 10-day washout period, crossover participants received brigatinib 90 mg, tablets, orally, QD for first 7 days followed by 180 mg, tablets, orally, QD in each 28-day cycle up to end of the study (The median duration of exposure was 17.25 months).
    id
    OG002
    title
    Crossover Phase: Brigatinib 90 mg QD/180 mg QD
param Type
MEDIAN
population Description
ITT Population included all participants randomized to each regimen regardless of whether they tested ALK+, or whether they received study drug or adhered to the assigned dose. Overall number of participants analyzed are the participants with data available for analyses.
reporting Status
POSTED
time Frame
Baseline up to end of study (Up to 56 months)
title
Intracranial Progression Free Survival
type
SECONDARY
unit Of Measure
months

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Preserved source evidence · Not medical advice