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NCT02516241 · OUTCOME

PFS2, PD-L1-High Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Monotherapy vs SoC

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 first confirmed disease progression, disease then assessed per local practice until 2nd progression. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).

What was measured

Time from randomization to second progression or death (PFS2) was defined as the time from the date of randomization to the earliest of the progression event subsequent to first subsequent therapy or death (ie, date of PFS2 event or censoring - date of randomization +1). Median PFS2 was calculated using the Kaplan-Meier technique.

Analysis population: The PD-L1-High analysis set will include the subset of patients in the FAS whose PD-L1 status is PD-L1-High 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 OR ≥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 Therapy205
Monotherapy209
Standard of Care207

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Combination Therapy17.2Not reported12.124.8Not reported
Monotherapy13.4Not reported9.717.5Not reported
Standard of Care11.3Not reported8.914.3Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.549
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.901
    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
    0.0053
    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
    0.70
    statistical Method
    Log Rank
  2. ci Lower Limit
    0.651
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.059
    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. OG001
    2. OG002
    non Inferiority Type
    SUPERIORITY
    p Value
    0.1336
    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
    0.83
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.549
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.901
    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
    0.0053
    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
    0.70
    statistical Method
    Log Rank
  2. ci Lower Limit
    0.651
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.059
    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. OG001
    2. OG002
    non Inferiority Type
    SUPERIORITY
    p Value
    0.1336
    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
    0.83
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        12.1
        upper Limit
        24.8
        value
        17.2
      2. group Id
        OG001
        lower Limit
        9.7
        upper Limit
        17.5
        value
        13.4
      3. group Id
        OG002
        lower Limit
        8.9
        upper Limit
        14.3
        value
        11.3
denoms
  1. counts
    1. group Id
      OG000
      value
      205
    2. group Id
      OG001
      value
      209
    3. group Id
      OG002
      value
      207
    units
    Participants
description
Time from randomization to second progression or death (PFS2) was defined as the time from the date of randomization to the earliest of the progression event subsequent to first subsequent therapy or death (ie, date of PFS2 event or censoring - date of randomization +1). Median PFS2 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-High analysis set will include the subset of patients in the FAS whose PD-L1 status is PD-L1-High 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 OR ≥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 first confirmed disease progression, disease then assessed per local practice until 2nd progression. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).
title
PFS2, PD-L1-High Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Monotherapy vs SoC
type
SECONDARY
unit Of Measure
Months

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Preserved source evidence · Not medical advice