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NCT03434379 · OUTCOME

PFS-IRF Per RECIST v1.1 by Baseline AFP in the Global Population

A Study of Atezolizumab in Combination With Bevacizumab Compared With Sorafenib in Patients With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma · Source last updated 2023-10-23

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
Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)

What was measured

PFS was defined as the time from randomization to the first occurrence of progressive disease or death from any cause whichever occurs first as determined by the IRF according to RECIST v1.1. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 millimeters (mm). Subpopulations with baseline AFP \<400 ng/mL and AFP\>/= 400 ng/mL were analyzed.

Analysis population: Global ITT population consisted of all randomized participants in the Global population, whether or not the participant had received the assigned study treatment.

Groups in this outcome

Sorafenib - Global

Participants in the Global population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.

Atezolizumab + Bevacizumab - Global

Participants in the Global population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.

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

Analysis denominator · Participants

GroupSource count
Sorafenib - Global165
Atezolizumab + Bevacizumab - Global336

Reported measurements

AFP <400 ng/mL

Analysis denominator · Participants

GroupSource count
Sorafenib - Global104
Atezolizumab + Bevacizumab - Global210
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Sorafenib - Global4.40Not reported4.016.21Not reported
Atezolizumab + Bevacizumab - Global8.28Not reported6.8311.04Not reported
AFP >/=400 ng/mL

Analysis denominator · Participants

GroupSource count
Sorafenib - Global61
Atezolizumab + Bevacizumab - Global126
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Sorafenib - Global4.14Not reported2.765.26Not reported
Atezolizumab + Bevacizumab - Global5.19Not reported3.946.77Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.37
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.68
    group Description
    AFP\<400 ng/mL and stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence).
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <.0001
    param Type
    Hazard Ratio (HR)
    param Value
    0.50
    statistical Method
    Log Rank
  2. ci Lower Limit
    0.53
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.15
    group Description
    AFP \>/=400 ng/mL and stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence).
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.2159
    param Type
    Hazard Ratio (HR)
    param Value
    0.78
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.37
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.68
    group Description
    AFP\<400 ng/mL and stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence).
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <.0001
    param Type
    Hazard Ratio (HR)
    param Value
    0.50
    statistical Method
    Log Rank
  2. ci Lower Limit
    0.53
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.15
    group Description
    AFP \>/=400 ng/mL and stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence).
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.2159
    param Type
    Hazard Ratio (HR)
    param Value
    0.78
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4.01
        upper Limit
        6.21
        value
        4.40
      2. group Id
        OG001
        lower Limit
        6.83
        upper Limit
        11.04
        value
        8.28
    denoms
    1. counts
      1. group Id
        OG000
        value
        104
      2. group Id
        OG001
        value
        210
      units
      Participants
    title
    AFP <400 ng/mL
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.76
        upper Limit
        5.26
        value
        4.14
      2. group Id
        OG001
        lower Limit
        3.94
        upper Limit
        6.77
        value
        5.19
    denoms
    1. counts
      1. group Id
        OG000
        value
        61
      2. group Id
        OG001
        value
        126
      units
      Participants
    title
    AFP >/=400 ng/mL
denoms
  1. counts
    1. group Id
      OG000
      value
      165
    2. group Id
      OG001
      value
      336
    units
    Participants
description
PFS was defined as the time from randomization to the first occurrence of progressive disease or death from any cause whichever occurs first as determined by the IRF according to RECIST v1.1. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 millimeters (mm). Subpopulations with baseline AFP \<400 ng/mL and AFP\>/= 400 ng/mL were analyzed.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants in the Global population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
    id
    OG000
    title
    Sorafenib - Global
  2. description
    Participants in the Global population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
    id
    OG001
    title
    Atezolizumab + Bevacizumab - Global
param Type
MEDIAN
population Description
Global ITT population consisted of all randomized participants in the Global population, whether or not the participant had received the assigned study treatment.
reporting Status
POSTED
time Frame
Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
title
PFS-IRF Per RECIST v1.1 by Baseline AFP in the Global Population
type
SECONDARY
unit Of Measure
months

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Preserved source evidence · Not medical advice