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NCT02516241 · OUTCOME

PFS, PD-L1-Low/Negative Analysis Set -Durvalumab + Tremelimumab Combination Therapy Versus SoC and Durvalumab + Tremelimumab Combination Therapy Versus Durvalumab Monotherapy

Study of MEDI4736 (Durvalumab) With or Without Tremelimumab Versus Standard of Care Chemotherapy in Urothelial Cancer · Source last updated 2026-07-14

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
Tumour scans performed at baseline then every 8 weeks since randomization until confirmed disease progression. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).

What was measured

Progression free survival (PFS) (per RECIST 1.1, as assessed by investigator) was defined as the time from the date of randomization until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient withdraws from randomized therapy or receives another anticancer therapy prior to progression. Median PFS was calculated using the Kaplan-Meier technique.

Analysis population: The PD-L1-Low/Negative analysis set will include the subset of patients in the FAS whose PD-L1 status is PD-L1-Low/negative as defined by an Immunohistochemistry (IHC) assay developed by Ventana as: \<25% tumor cell membrane positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control AND \<25% tumor associated immune cell positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control.

Groups in this outcome

Combination Therapy

MEDI4736 (Durvalumab) + Tremelimumab

Monotherapy

MEDI4736 (Durvalumab)

Standard of Care

Standard of Care Chemotherapy Treatment

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

Analysis denominator · Participants

GroupSource count
Combination Therapy137
Monotherapy137
Standard of Care137

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Combination Therapy2.0Not reported1.93.6Not reported
Monotherapy2.0Not reported1.93.5Not reported
Standard of Care7.2Not reported5.77.5Not reported

Source statistical analyses

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

  1. ci Lower Limit
    1.177
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.990
    estimate Comment
    The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0014
    p Value Comment
    The 2-sided p-value was calculated using a stratified log-rank test adjusting for visceral metastases and cisplatin eligibility status.
    param Type
    Hazard Ratio (HR)
    param Value
    1.53
    statistical Method
    Log Rank
  2. ci Lower Limit
    0.729
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.209
    estimate Comment
    The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.
    group Description
    monotherapy as reference.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.6236
    p Value Comment
    The 2-sided p-value was calculated using a stratified log-rank test adjusting for visceral metastases and cisplatin eligibility status.
    param Type
    Hazard Ratio (HR)
    param Value
    0.94
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    1.177
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.990
    estimate Comment
    The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0014
    p Value Comment
    The 2-sided p-value was calculated using a stratified log-rank test adjusting for visceral metastases and cisplatin eligibility status.
    param Type
    Hazard Ratio (HR)
    param Value
    1.53
    statistical Method
    Log Rank
  2. ci Lower Limit
    0.729
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.209
    estimate Comment
    The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.
    group Description
    monotherapy as reference.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.6236
    p Value Comment
    The 2-sided p-value was calculated using a stratified log-rank test adjusting for visceral metastases and cisplatin eligibility status.
    param Type
    Hazard Ratio (HR)
    param Value
    0.94
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.9
        upper Limit
        3.6
        value
        2.0
      2. group Id
        OG001
        lower Limit
        1.9
        upper Limit
        3.5
        value
        2.0
      3. group Id
        OG002
        lower Limit
        5.7
        upper Limit
        7.5
        value
        7.2
denoms
  1. counts
    1. group Id
      OG000
      value
      137
    2. group Id
      OG001
      value
      137
    3. group Id
      OG002
      value
      137
    units
    Participants
description
Progression free survival (PFS) (per RECIST 1.1, as assessed by investigator) was defined as the time from the date of randomization until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient withdraws from randomized therapy or receives another anticancer therapy prior to progression. Median PFS was calculated using the Kaplan-Meier technique.
dispersion Type
95% Confidence Interval
groups
  1. description
    MEDI4736 (Durvalumab) + Tremelimumab
    id
    OG000
    title
    Combination Therapy
  2. description
    MEDI4736 (Durvalumab)
    id
    OG001
    title
    Monotherapy
  3. description
    Standard of Care Chemotherapy Treatment
    id
    OG002
    title
    Standard of Care
param Type
MEDIAN
population Description
The PD-L1-Low/Negative analysis set will include the subset of patients in the FAS whose PD-L1 status is PD-L1-Low/negative as defined by an Immunohistochemistry (IHC) assay developed by Ventana as: \<25% tumor cell membrane positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control AND \<25% tumor associated immune cell positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control.
reporting Status
POSTED
time Frame
Tumour scans performed at baseline then every 8 weeks since randomization until confirmed disease progression. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).
title
PFS, PD-L1-Low/Negative Analysis Set -Durvalumab + Tremelimumab Combination Therapy Versus SoC and Durvalumab + Tremelimumab Combination Therapy Versus Durvalumab Monotherapy
type
SECONDARY
unit Of Measure
Months

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Preserved source evidence · Not medical advice