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NCT02576509 · OUTCOME

Efficacy Based on PD-L1 Expression - ORR

An Investigational Immuno-therapy Study of Nivolumab Compared to Sorafenib as a First Treatment in Patients With Advanced Hepatocellular Carcinoma · Source last updated 2025-02-17

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
the date of randomization and the date of first objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first, assessed up to May 2019 (approximately 40 months)

What was measured

PD-L1 expression is defined as the percent of tumor cell membrane staining in a minimum of 100 evaluable tumor cells per Dako PD-L1 IHC assay unless otherwise specified. This is referred as quantifiable PD-L1 expression. If the PD-L1 staining could not be quantified, it is further classifies as: Indeterminate: Tumor cell membrane staining hampered for reasons attributed to the biology of the tumor biopsy specimen and not because of improper sample preparation or handling. Not evaluable: Tumor biopsy specimen was not optimally collected or prepared (e.g. PD-L1 expression is neither quantifiable nor indeterminate). PD-L1 status is a dichotomized variable using an X% cut-off for quantifiable PD-L1 expression: * PD-L1 \> X %: ≥ X % PD-L1 expression * PD-L1 \< X %: \< X % PD-L1 expression where X% denotes the PD-L1 expression cut-off of 1%. Additional cut off values may also be explored. Confidence interval based on the Clopper and Pearson method.

Analysis population: all randomized participants with a \>=1% PD-L1 expression all randomized participants with a \<1% PD-L1 expression all randomized participants without PD-L1 quantifiable Note: odds ratio for participants without PD-L1 quantifiable cannot be estimated based on the data

Groups in this outcome

Nivolumab 240 mg

Nivolumab 240 mg intravenously (IV) every 2 weeks until disease progression or unacceptable toxicity

Sorafenib 400 mg

Sorafenib 400 mg orally (PO) twice a day (BID) until disease progression or unacceptable 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
Nivolumab 240 mg371
Sorafenib 400 mg372

Reported measurements

>=1%, ORR

Analysis denominator · Participants

GroupSource count
Nivolumab 240 mg71
Sorafenib 400 mg64
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Nivolumab 240 mg28.2Not reported18.140.1Not reported
Sorafenib 400 mg9.4Not reported3.519.3Not reported
<1%, ORR

Analysis denominator · Participants

GroupSource count
Nivolumab 240 mg295
Sorafenib 400 mg300
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Nivolumab 240 mg12.2Not reported8.716.5Not reported
Sorafenib 400 mg6.7Not reported4.110.1Not reported
without PD-L1 quantifiable, ORR

Analysis denominator · Participants

GroupSource count
Nivolumab 240 mg5
Sorafenib 400 mg8
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Nivolumab 240 mg20.0Not reported0.571.6Not reported
Sorafenib 400 mg0.0Not reported0.036.9Not reported

Source statistical analyses

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

  1. ci Lower Limit
    1.41
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    10.17
    estimate Comment
    Odds ratio (Nivolumab over Sorafenib) and associated unstratified 95% exact CI.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    PD-L1 \>=1%, ORR; no test was performed
    non Inferiority Type
    OTHER
    param Type
    Odds Ratio (OR)
    param Value
    3.79
  2. ci Lower Limit
    1.10
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    3.45
    estimate Comment
    Odds ratio (Nivolumab over Sorafenib) and associated unstratified 95% exact CI
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    PD-L1 \<1%, ORR; no test was performed
    non Inferiority Type
    OTHER
    param Type
    Odds Ratio (OR)
    param Value
    1.95
Complete source fields
analyses
  1. ci Lower Limit
    1.41
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    10.17
    estimate Comment
    Odds ratio (Nivolumab over Sorafenib) and associated unstratified 95% exact CI.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    PD-L1 \>=1%, ORR; no test was performed
    non Inferiority Type
    OTHER
    param Type
    Odds Ratio (OR)
    param Value
    3.79
  2. ci Lower Limit
    1.10
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    3.45
    estimate Comment
    Odds ratio (Nivolumab over Sorafenib) and associated unstratified 95% exact CI
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    PD-L1 \<1%, ORR; no test was performed
    non Inferiority Type
    OTHER
    param Type
    Odds Ratio (OR)
    param Value
    1.95
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        18.1
        upper Limit
        40.1
        value
        28.2
      2. group Id
        OG001
        lower Limit
        3.5
        upper Limit
        19.3
        value
        9.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        71
      2. group Id
        OG001
        value
        64
      units
      Participants
    title
    >=1%, ORR
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        8.7
        upper Limit
        16.5
        value
        12.2
      2. group Id
        OG001
        lower Limit
        4.1
        upper Limit
        10.1
        value
        6.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        295
      2. group Id
        OG001
        value
        300
      units
      Participants
    title
    <1%, ORR
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.5
        upper Limit
        71.6
        value
        20.0
      2. group Id
        OG001
        lower Limit
        0.0
        upper Limit
        36.9
        value
        0.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        8
      units
      Participants
    title
    without PD-L1 quantifiable, ORR
denoms
  1. counts
    1. group Id
      OG000
      value
      371
    2. group Id
      OG001
      value
      372
    units
    Participants
description
PD-L1 expression is defined as the percent of tumor cell membrane staining in a minimum of 100 evaluable tumor cells per Dako PD-L1 IHC assay unless otherwise specified. This is referred as quantifiable PD-L1 expression. If the PD-L1 staining could not be quantified, it is further classifies as: Indeterminate: Tumor cell membrane staining hampered for reasons attributed to the biology of the tumor biopsy specimen and not because of improper sample preparation or handling. Not evaluable: Tumor biopsy specimen was not optimally collected or prepared (e.g. PD-L1 expression is neither quantifiable nor indeterminate). PD-L1 status is a dichotomized variable using an X% cut-off for quantifiable PD-L1 expression: * PD-L1 \> X %: ≥ X % PD-L1 expression * PD-L1 \< X %: \< X % PD-L1 expression where X% denotes the PD-L1 expression cut-off of 1%. Additional cut off values may also be explored. Confidence interval based on the Clopper and Pearson method.
dispersion Type
95% Confidence Interval
groups
  1. description
    Nivolumab 240 mg intravenously (IV) every 2 weeks until disease progression or unacceptable toxicity
    id
    OG000
    title
    Nivolumab 240 mg
  2. description
    Sorafenib 400 mg orally (PO) twice a day (BID) until disease progression or unacceptable toxicity
    id
    OG001
    title
    Sorafenib 400 mg
param Type
NUMBER
population Description
all randomized participants with a \>=1% PD-L1 expression all randomized participants with a \<1% PD-L1 expression all randomized participants without PD-L1 quantifiable Note: odds ratio for participants without PD-L1 quantifiable cannot be estimated based on the data
reporting Status
POSTED
time Frame
the date of randomization and the date of first objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first, assessed up to May 2019 (approximately 40 months)
title
Efficacy Based on PD-L1 Expression - ORR
type
SECONDARY
unit Of Measure
Percentage of participants

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