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NCT01631552 · OUTCOME

Clinical Benefit Rate (CBR) by Local Assessment

Study of Sacituzumab Govitecan-hziy (IMMU-132) in Adults With Epithelial Cancer · Source last updated 2021-08-12

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 data cutoff date of 01 March 2019 (maximum duration: 74 months)

What was measured

Clinical benefit rate (CR+PR+\[stable disease (SD) ≥ 6 months\]) is defined as those participants with best response as CR or PR or else SD with a duration of at least 6 months. SD for 6 months duration was defined as the time from the first dose to the first documentation of PD or to the last adequate response assessment prior to data cut-off date, whichever is earlier. Per planned analysis, CBR by local assessment was assessed for TNBC Target Population, HR+/HER2-mBC Population, and mUC Population.

Analysis population: * Target mTNBC: Participants with mTNBC who received at least 2 prior therapies for metastatic disease \& who received at least 1 dose of 10 mg/kg SG * HR+/HER2-mBC: Participants with HR+/HER2- mBC who progressed on at least 1 prior hormonal therapy \& who received at least 1 dose of 10 mg/kg SG * mUC: Participants who had relapsed after or were refractory to at least 1 prior treatments \& who received at least 1 dose of 10 mg/kg SG

Groups in this outcome

TNBC Target Population

Overall 144 participants with TNBC were enrolled in the study and received at least one dose of SG. Of these 144 participants, 108 received at least 2 prior therapies for metastatic disease and were treated with SG at a starting dose of 10mg/kg. These 108 participants were included in the analysis of safety and were referred to as the TNBC Target Population.

HR+/HER2- mBC Population

Overall 68 participants with non-TNBC were enrolled in the study and received at least one dose of SG. Of these 68 participants, 54 were confirmed as HR+/HER2-, had progressed on at least one prior hormonal therapy in the metastatic setting, and had received at least one dose of 10 mg/kg SG. These 54 participants were included in the analysis of safety and were referred to as the HR+/HER2- mBC Population.

mUC Population

Overall 49 participants with metastatic urothelial cancer were enrolled in the study and received at least one dose of SG. Of these 49 participants, 45 had either relapsed after or were refractory to at least one prior standard therapeutic regimen and received at least one dose of 10 mg/kg SG. These 45 participants were included in the analysis of safety and were referred to as the mUC Population.

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

Analysis denominator · Participants

GroupSource count
TNBC Target Population108
HR+/HER2- mBC Population54
mUC Population45

Reported measurements

Source class 1
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
TNBC Target Population45.4Not reported35.855.2Not reported
HR+/HER2- mBC Population44.4Not reported30.958.6Not reported
mUC Population44.4Not reported29.660.0Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        35.8
        upper Limit
        55.2
        value
        45.4
      2. group Id
        OG001
        lower Limit
        30.9
        upper Limit
        58.6
        value
        44.4
      3. group Id
        OG002
        lower Limit
        29.6
        upper Limit
        60.0
        value
        44.4
denoms
  1. counts
    1. group Id
      OG000
      value
      108
    2. group Id
      OG001
      value
      54
    3. group Id
      OG002
      value
      45
    units
    Participants
description
Clinical benefit rate (CR+PR+\[stable disease (SD) ≥ 6 months\]) is defined as those participants with best response as CR or PR or else SD with a duration of at least 6 months. SD for 6 months duration was defined as the time from the first dose to the first documentation of PD or to the last adequate response assessment prior to data cut-off date, whichever is earlier. Per planned analysis, CBR by local assessment was assessed for TNBC Target Population, HR+/HER2-mBC Population, and mUC Population.
dispersion Type
95% Confidence Interval
groups
  1. description
    Overall 144 participants with TNBC were enrolled in the study and received at least one dose of SG. Of these 144 participants, 108 received at least 2 prior therapies for metastatic disease and were treated with SG at a starting dose of 10mg/kg. These 108 participants were included in the analysis of safety and were referred to as the TNBC Target Population.
    id
    OG000
    title
    TNBC Target Population
  2. description
    Overall 68 participants with non-TNBC were enrolled in the study and received at least one dose of SG. Of these 68 participants, 54 were confirmed as HR+/HER2-, had progressed on at least one prior hormonal therapy in the metastatic setting, and had received at least one dose of 10 mg/kg SG. These 54 participants were included in the analysis of safety and were referred to as the HR+/HER2- mBC Population.
    id
    OG001
    title
    HR+/HER2- mBC Population
  3. description
    Overall 49 participants with metastatic urothelial cancer were enrolled in the study and received at least one dose of SG. Of these 49 participants, 45 had either relapsed after or were refractory to at least one prior standard therapeutic regimen and received at least one dose of 10 mg/kg SG. These 45 participants were included in the analysis of safety and were referred to as the mUC Population.
    id
    OG002
    title
    mUC Population
param Type
NUMBER
population Description
* Target mTNBC: Participants with mTNBC who received at least 2 prior therapies for metastatic disease \& who received at least 1 dose of 10 mg/kg SG * HR+/HER2-mBC: Participants with HR+/HER2- mBC who progressed on at least 1 prior hormonal therapy \& who received at least 1 dose of 10 mg/kg SG * mUC: Participants who had relapsed after or were refractory to at least 1 prior treatments \& who received at least 1 dose of 10 mg/kg SG
reporting Status
POSTED
time Frame
Up to data cutoff date of 01 March 2019 (maximum duration: 74 months)
title
Clinical Benefit Rate (CBR) by Local Assessment
type
SECONDARY
unit Of Measure
Percentage of participants

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Preserved source evidence · Not medical advice