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NCT02853305 · OUTCOME

Pembro vs Chemo: DOR Using RECIST 1.1 as Assessed by BICR

Study of Pembrolizumab With or Without Platinum-based Combination Chemotherapy Versus Chemotherapy Alone in Urothelial Carcinoma (MK-3475-361/KEYNOTE-361) · Source last updated 2023-09-08

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
Up to approximately 42 months

What was measured

For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 based upon BICR, DOR was defined as the time from first documented evidence of confirmed CR or PR until PD or death, whichever occurred first. DOR for participants who had not progressed or died at the time of analysis was censored at the date of their last tumor assessment. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. DOR is reported here for all participants in the pembro arm and chemo arm who had CR or PR. Per protocol, DOR was assessed separately in responders of the pembro combo arm and chemo arm and is presented earlier in the record.

Analysis population: All participants in the ITT population randomized to the pembro arm and chemo arm who demonstrated a confirmed CR or PR were included in the analysis. Per protocol, the pembro combo arm was compared to the chemo arm separately and not included in this analysis.

Groups in this outcome

Pembrolizumab + ST Chemotherapy (Pembro Combo)

Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for a maximum of 35 doses PLUS standard therapy (ST) chemotherapy with EITHER cisplatin 70 mg/m\^2 IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine IV infusion 1,000 mg/m\^2 on Day 1 and Day 8 of each 3-week cycle, OR carboplatin at an area under the curve 5 (AUC 5) (or AUC 4.5 if required per local guidelines) IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine 1,000 mg/m\^2 IV on Day 1 and Day 8 of each 3-week cycle.

Pembrolizumab (Pembro)

Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for a maximum of 35 doses.

ST Chemotherapy (Chemo)

Participants received ST chemotherapy with EITHER cisplatin 70 mg/m\^2 IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine IV infusion 1,000 mg/m\^2 on Day 1 and Day 8 of each 3-week cycle OR carboplatin at AUC 5 (or AUC 4.5 if required per local guidelines) IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine 1,000 mg/m\^2 IV on Day 1 and Day 8 of each 3-week cycle.

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

Analysis denominator · Participants

GroupSource count
Pembrolizumab + ST Chemotherapy (Pembro Combo)0
Pembrolizumab (Pembro)93
ST Chemotherapy (Chemo)158

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pembrolizumab (Pembro)28.2Not reported13.5NANA= DOR upper 95% confidence limit undefined because the DOR rate was not low enough at the time of the cut-off date
ST Chemotherapy (Chemo)6.2Not reported5.86.6Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        NA= DOR upper 95% confidence limit undefined because the DOR rate was not low enough at the time of the cut-off date
        group Id
        OG001
        lower Limit
        13.5
        upper Limit
        NA
        value
        28.2
      2. group Id
        OG002
        lower Limit
        5.8
        upper Limit
        6.6
        value
        6.2
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      93
    3. group Id
      OG002
      value
      158
    units
    Participants
description
For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 based upon BICR, DOR was defined as the time from first documented evidence of confirmed CR or PR until PD or death, whichever occurred first. DOR for participants who had not progressed or died at the time of analysis was censored at the date of their last tumor assessment. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. DOR is reported here for all participants in the pembro arm and chemo arm who had CR or PR. Per protocol, DOR was assessed separately in responders of the pembro combo arm and chemo arm and is presented earlier in the record.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for a maximum of 35 doses PLUS standard therapy (ST) chemotherapy with EITHER cisplatin 70 mg/m\^2 IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine IV infusion 1,000 mg/m\^2 on Day 1 and Day 8 of each 3-week cycle, OR carboplatin at an area under the curve 5 (AUC 5) (or AUC 4.5 if required per local guidelines) IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine 1,000 mg/m\^2 IV on Day 1 and Day 8 of each 3-week cycle.
    id
    OG000
    title
    Pembrolizumab + ST Chemotherapy (Pembro Combo)
  2. description
    Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for a maximum of 35 doses.
    id
    OG001
    title
    Pembrolizumab (Pembro)
  3. description
    Participants received ST chemotherapy with EITHER cisplatin 70 mg/m\^2 IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine IV infusion 1,000 mg/m\^2 on Day 1 and Day 8 of each 3-week cycle OR carboplatin at AUC 5 (or AUC 4.5 if required per local guidelines) IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine 1,000 mg/m\^2 IV on Day 1 and Day 8 of each 3-week cycle.
    id
    OG002
    title
    ST Chemotherapy (Chemo)
param Type
MEDIAN
population Description
All participants in the ITT population randomized to the pembro arm and chemo arm who demonstrated a confirmed CR or PR were included in the analysis. Per protocol, the pembro combo arm was compared to the chemo arm separately and not included in this analysis.
reporting Status
POSTED
time Frame
Up to approximately 42 months
title
Pembro vs Chemo: DOR Using RECIST 1.1 as Assessed by BICR
type
SECONDARY
unit Of Measure
Months

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Preserved source evidence · Not medical advice