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NCT03732677 · OUTCOME

Event-free Survival at 24 Months (EFS24) Per Central Review Defined as Time From Randomization to Event

Durvalumab+ Gemcitabine/Cisplatin (Neoadjuvant Treatment) and Durvalumab (Adjuvant Treatment) in Patients With MIBC · Source last updated 2026-07-17

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
Up to 24 months

What was measured

EFS24 is defined as the Kaplan-Meier estimate of EFS at 24 months after randomization, as assessed per blinded independent central review or by central pathology review if a biopsy is required for a suspected new lesion, and per local investigator or local biopsy review if a biopsy is required for a suspected new lesion

Analysis population: The full analysis set (FAS) Intention to treat included all randomized patients

Groups in this outcome

Durvalumab + Gemcitabine + Cisplatin

Treatments and dosing regimens: Durvalumab 1500 mg IV q3w (neoadjuvant) 1500 mg IV q4w (adjuvant post-radical cystectomy) Day 1 and Day 8 (gemcitabine 1000 mg/m2 IV) of each 21-day cycle (neoadjuvant) Day 1 and Day 8 (cisplatin 35mg/m2 IV) or Day 1 (cisplatin 70 mg/m2 IV) each 21-day cycle (neoadjuvant) Dosing will be adjusted based on renal function

Gemcitabine + Cisplatin

Treatments and dosing regimens: Day 1 and Day 8 (gemcitabine1000 mg/m2 IV) of each 21-day cycle (neoadjuvant) Day 1 and Day 8 (cisplatin 35mg/m2 IV) or Day 1 (cisplatin 70 mg/m2 IV) each 21-day cycle (neoadjuvant) Dosing will be adjusted based on renal function

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

Analysis denominator · Participants

GroupSource count
Durvalumab + Gemcitabine + Cisplatin533
Gemcitabine + Cisplatin530

Reported measurements

Source class 1
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Durvalumab + Gemcitabine + Cisplatin67.8Not reported63.671.7Not reported
Gemcitabine + Cisplatin59.8Not reported55.464Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.62
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.90
    estimate Comment
    The HR and CI were estimated from a stratified Cox proportional hazard model adjusting for renal function (adequate vs borderline), tumor stage (T2N0 vs \>T2N0) and PDL1 status (high vs low/negative)
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0021
    param Type
    Hazard Ratio (HR)
    param Value
    0.75
    statistical Comment
    P-value is based on a chi-squared test with one degree of freedom.
    statistical Method
    Chi-squared
Complete source fields
analyses
  1. ci Lower Limit
    0.62
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.90
    estimate Comment
    The HR and CI were estimated from a stratified Cox proportional hazard model adjusting for renal function (adequate vs borderline), tumor stage (T2N0 vs \>T2N0) and PDL1 status (high vs low/negative)
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0021
    param Type
    Hazard Ratio (HR)
    param Value
    0.75
    statistical Comment
    P-value is based on a chi-squared test with one degree of freedom.
    statistical Method
    Chi-squared
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        63.6
        upper Limit
        71.7
        value
        67.8
      2. group Id
        OG001
        lower Limit
        55.4
        upper Limit
        64
        value
        59.8
denoms
  1. counts
    1. group Id
      OG000
      value
      533
    2. group Id
      OG001
      value
      530
    units
    Participants
description
EFS24 is defined as the Kaplan-Meier estimate of EFS at 24 months after randomization, as assessed per blinded independent central review or by central pathology review if a biopsy is required for a suspected new lesion, and per local investigator or local biopsy review if a biopsy is required for a suspected new lesion
dispersion Type
95% Confidence Interval
groups
  1. description
    Treatments and dosing regimens: Durvalumab 1500 mg IV q3w (neoadjuvant) 1500 mg IV q4w (adjuvant post-radical cystectomy) Day 1 and Day 8 (gemcitabine 1000 mg/m2 IV) of each 21-day cycle (neoadjuvant) Day 1 and Day 8 (cisplatin 35mg/m2 IV) or Day 1 (cisplatin 70 mg/m2 IV) each 21-day cycle (neoadjuvant) Dosing will be adjusted based on renal function
    id
    OG000
    title
    Durvalumab + Gemcitabine + Cisplatin
  2. description
    Treatments and dosing regimens: Day 1 and Day 8 (gemcitabine1000 mg/m2 IV) of each 21-day cycle (neoadjuvant) Day 1 and Day 8 (cisplatin 35mg/m2 IV) or Day 1 (cisplatin 70 mg/m2 IV) each 21-day cycle (neoadjuvant) Dosing will be adjusted based on renal function
    id
    OG001
    title
    Gemcitabine + Cisplatin
param Type
NUMBER
population Description
The full analysis set (FAS) Intention to treat included all randomized patients
reporting Status
POSTED
time Frame
Up to 24 months
title
Event-free Survival at 24 Months (EFS24) Per Central Review Defined as Time From Randomization to Event
type
SECONDARY
unit Of Measure
Percentage of participants

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Preserved source evidence · Not medical advice