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NCT04602078 · OUTCOME

Progression Free Survival Measured by RECIST 1.1 in Patients Grouped According to Their PD-L1 Expression

Study of Atezolizumab Combined With Split-dose Gemcitabine Plus Cisplatin in Urothelial Carcinoma · Source last updated 2025-04-24

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
PD-L1 expression measured at the end of the trial. PFS assessed Through study completion, average 2 years

What was measured

Correlation between the expression of PD-L1 with PFS during experimental treatment. Patients will be grouped based on the PD-L1 expression levels in PD-L1 positive or negative patients. Progression free survival will be assessed in both groups of patients and compared to identify potential statistically significant differences between groups.

Analysis population: 26 patients had no PD-L1 determined

Groups in this outcome

AUREA Single-arm

Atezolizumab (1200 mg) intravenously administered every 21 days (one cycle) up to disease progression, unacceptable toxicity or absence of clinical benefit. Gemcitabine 1000 mg/m2 IV on D1 and 1000 mg/m2 IV on D8 of each 21-day cycle plus Cisplatin 70 mg/m2 by IV on split-dose schedule of 35 mg/m2 on day 1 (D1) and 35 mg/m2 on day 8 (D8) for up to 6 cycles. Atezolizumab 1200 mg/m2: Fixed dose of 1200 mg/m2 by intravenous (IV) infusion on D1 of each cycle up to disease progression, unacceptable toxicity or absence of clinical benefit. Gemcitabine 1000 mg/m2: Gemcitabine 1000 mg/m2 IV on D1 and 1000 mg/m2 IV on D8 of each 21-day cycle for up to 6 cycles. Cisplatin 70 mg/m2: Cisplatin 70 mg/m2 by IV on split-dose schedule of 35 mg/m2 on day 1 (D1) and 35 mg/m2 on day 8 (D8) for up to 6 cycles.

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

Analysis denominator · Participants

GroupSource count
AUREA Single-arm40

Reported measurements

PD-L1 positive

Analysis denominator · Participants

GroupSource count
AUREA Single-arm14
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
AUREA Single-arm6.9Not reported6.417Not reported
PD-L1 negative

Analysis denominator · Participants

GroupSource count
AUREA Single-arm26
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
AUREA Single-arm6.9Not reported69.7Not reported

Source statistical analyses

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

  1. group Description
    Comparisong between subgroups: patients with PD-L1 postive versus patients with PD-L1 negative
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY
    p Value
    0.444
    statistical Method
    Log Rank
Complete source fields
analyses
  1. group Description
    Comparisong between subgroups: patients with PD-L1 postive versus patients with PD-L1 negative
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY
    p Value
    0.444
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        6.4
        upper Limit
        17
        value
        6.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        14
      units
      Participants
    title
    PD-L1 positive
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        6
        upper Limit
        9.7
        value
        6.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        26
      units
      Participants
    title
    PD-L1 negative
denoms
  1. counts
    1. group Id
      OG000
      value
      40
    units
    Participants
description
Correlation between the expression of PD-L1 with PFS during experimental treatment. Patients will be grouped based on the PD-L1 expression levels in PD-L1 positive or negative patients. Progression free survival will be assessed in both groups of patients and compared to identify potential statistically significant differences between groups.
dispersion Type
95% Confidence Interval
groups
  1. description
    Atezolizumab (1200 mg) intravenously administered every 21 days (one cycle) up to disease progression, unacceptable toxicity or absence of clinical benefit. Gemcitabine 1000 mg/m2 IV on D1 and 1000 mg/m2 IV on D8 of each 21-day cycle plus Cisplatin 70 mg/m2 by IV on split-dose schedule of 35 mg/m2 on day 1 (D1) and 35 mg/m2 on day 8 (D8) for up to 6 cycles. Atezolizumab 1200 mg/m2: Fixed dose of 1200 mg/m2 by intravenous (IV) infusion on D1 of each cycle up to disease progression, unacceptable toxicity or absence of clinical benefit. Gemcitabine 1000 mg/m2: Gemcitabine 1000 mg/m2 IV on D1 and 1000 mg/m2 IV on D8 of each 21-day cycle for up to 6 cycles. Cisplatin 70 mg/m2: Cisplatin 70 mg/m2 by IV on split-dose schedule of 35 mg/m2 on day 1 (D1) and 35 mg/m2 on day 8 (D8) for up to 6 cycles.
    id
    OG000
    title
    AUREA Single-arm
param Type
MEDIAN
population Description
26 patients had no PD-L1 determined
reporting Status
POSTED
time Frame
PD-L1 expression measured at the end of the trial. PFS assessed Through study completion, average 2 years
title
Progression Free Survival Measured by RECIST 1.1 in Patients Grouped According to Their PD-L1 Expression
type
OTHER_PRE_SPECIFIED
unit Of Measure
months

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Preserved source evidence · Not medical advice