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NCT05565391 · OUTCOME

Duration of Response-Comparison Between Elranatamab in Study C1071003 Cohort A and COTA Cohort Using IPTW Analysis

A Study to Learn About the Medicine (Called Elranatamab) in People With Relapsed Refractory Multiple Myeloma · Source last updated 2024-05-21

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
From first documentation of OR until confirmed PD or death due to any cause or censoring date (median follow-up of 10.4 months for study C1071003 cohort A, 8.8 months and 7.7 months for COTA and Flatiron Health cohorts)

What was measured

DOR was defined as the time from the first documentation of OR, until confirmed disease progression (PD) per IMWG criteria, or death due to any cause, whichever occurred first. PD= increase of \>=25% from lowest value in \>=1 of following (serum M-protein \[absolute increase \>=0.5g/dL\]; serum M-protein increase \>=1g/dL \[when lowest M-protein \>=5g/dL\]; and urine M-protein \[absolute increase \>=200mg/24h\]). Median and 95% Confidence Interval (CI) reported in the descriptive section was determined using unweighted analysis.

Analysis population: Eligible participants from study C1071003 (Cohort A) and RW participants identified from COTA and Flatiron Health databases were included. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure.

Groups in this outcome

Study C1071003 Cohort A

Participants with TCR MM who initiated elranatamab (PF-06863135) following TCR eligibility in study C1071003 (NCT04649359) were included.

COTA Cohort

Participants with RW TCR MM who initiated standard of care treatment following TCR eligibility between 16-Nov-2015 and 31-Mar-2022 identified from COTA database were included.

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

Analysis denominator · Participants

GroupSource count
Study C1071003 Cohort A75
COTA Cohort68

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Study C1071003 Cohort ANANot reported11.99NAMedian and upper limit of 95% CI could not be calculated due to insufficient number of participants with events.
COTA Cohort4.37Not reported2.868.05Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.06
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.22
    estimate Comment
    Hazard ratio was estimated using weighted Cox proportional hazard model and confidence interval was estimated using robust error variance.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    p Value
    <.0001
    param Type
    Hazard Ratio (HR)
    param Value
    0.11
    statistical Method
    Cox proportional hazard model
Complete source fields
analyses
  1. ci Lower Limit
    0.06
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.22
    estimate Comment
    Hazard ratio was estimated using weighted Cox proportional hazard model and confidence interval was estimated using robust error variance.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    p Value
    <.0001
    param Type
    Hazard Ratio (HR)
    param Value
    0.11
    statistical Method
    Cox proportional hazard model
classes
  1. categories
    1. measurements
      1. comment
        Median and upper limit of 95% CI could not be calculated due to insufficient number of participants with events.
        group Id
        OG000
        lower Limit
        11.99
        upper Limit
        NA
        value
        NA
      2. group Id
        OG001
        lower Limit
        2.86
        upper Limit
        8.05
        value
        4.37
denoms
  1. counts
    1. group Id
      OG000
      value
      75
    2. group Id
      OG001
      value
      68
    units
    Participants
description
DOR was defined as the time from the first documentation of OR, until confirmed disease progression (PD) per IMWG criteria, or death due to any cause, whichever occurred first. PD= increase of \>=25% from lowest value in \>=1 of following (serum M-protein \[absolute increase \>=0.5g/dL\]; serum M-protein increase \>=1g/dL \[when lowest M-protein \>=5g/dL\]; and urine M-protein \[absolute increase \>=200mg/24h\]). Median and 95% Confidence Interval (CI) reported in the descriptive section was determined using unweighted analysis.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants with TCR MM who initiated elranatamab (PF-06863135) following TCR eligibility in study C1071003 (NCT04649359) were included.
    id
    OG000
    title
    Study C1071003 Cohort A
  2. description
    Participants with RW TCR MM who initiated standard of care treatment following TCR eligibility between 16-Nov-2015 and 31-Mar-2022 identified from COTA database were included.
    id
    OG001
    title
    COTA Cohort
param Type
MEDIAN
population Description
Eligible participants from study C1071003 (Cohort A) and RW participants identified from COTA and Flatiron Health databases were included. Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure.
reporting Status
POSTED
time Frame
From first documentation of OR until confirmed PD or death due to any cause or censoring date (median follow-up of 10.4 months for study C1071003 cohort A, 8.8 months and 7.7 months for COTA and Flatiron Health cohorts)
title
Duration of Response-Comparison Between Elranatamab in Study C1071003 Cohort A and COTA Cohort Using IPTW Analysis
type
SECONDARY
unit Of Measure
Months

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Preserved source evidence · Not medical advice