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NCT05565391 · OUTCOME

Objective Response Rate-Comparison Between Elranatamab in Study C1071003 Cohort A and COTA Cohort Using Inverse Probability of Treatment Weights (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
NUMBER
Unit
Percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
From index date until first documentation of progression, death, or the start of new anticancer therapy (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

ORR was the percentage of participants with an OR per IMWG criteria. For the analysis set of participants from Study C1071003 and COTA, the OR was defined as PR or better (sCR + CR + VGPR + PR). For Study C1071003 and Flatiron Health, OR was defined as PR or better (at least VGPR + PR). sCR: CR \& normal serum free light chain (sFLC) ratio \& absence of clonal cells in BMB/BMA by IH, IF, or flow cytometry. CR: negative immunofixation on serum \& urine, disappearance of any soft tissue plasmacytoma \& \<5% plasma cells in BMA, if measured by sFLC only, preceding criteria + normal sFLC ratio. VGPR: Serum \& urine M-protein detectable by immunofixation but not on electrophoresis; or \>=90% reduction in serum \& urine M-protein level \<100mg/24h. PR: \>=50% reduction in serum M-protein \& reduction in 24h urinary M-protein by \>=90% or \<200 mg/24h. Analysis was performed using IPTW method to balance participant characteristics among reporting groups.

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 after application of IPTW method to raw numbers and is different from the actual participants included in the reporting arm.

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 A123
COTA Cohort213

Reported measurements

Source class 1
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Study C1071003 Cohort A75.7Not reported65.687.4Not reported
COTA Cohort34.2Not reported27.243.0Not reported

Source statistical analyses

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

  1. ci Lower Limit
    1.69
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.90
    estimate Comment
    Risk ratio was estimated using a log-binomial regression 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
    Risk Ratio (RR)
    param Value
    2.22
    statistical Method
    Log-binomial regression model
Complete source fields
analyses
  1. ci Lower Limit
    1.69
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.90
    estimate Comment
    Risk ratio was estimated using a log-binomial regression 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
    Risk Ratio (RR)
    param Value
    2.22
    statistical Method
    Log-binomial regression model
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        65.6
        upper Limit
        87.4
        value
        75.7
      2. group Id
        OG001
        lower Limit
        27.2
        upper Limit
        43.0
        value
        34.2
denoms
  1. counts
    1. group Id
      OG000
      value
      123
    2. group Id
      OG001
      value
      213
    units
    Participants
description
ORR was the percentage of participants with an OR per IMWG criteria. For the analysis set of participants from Study C1071003 and COTA, the OR was defined as PR or better (sCR + CR + VGPR + PR). For Study C1071003 and Flatiron Health, OR was defined as PR or better (at least VGPR + PR). sCR: CR \& normal serum free light chain (sFLC) ratio \& absence of clonal cells in BMB/BMA by IH, IF, or flow cytometry. CR: negative immunofixation on serum \& urine, disappearance of any soft tissue plasmacytoma \& \<5% plasma cells in BMA, if measured by sFLC only, preceding criteria + normal sFLC ratio. VGPR: Serum \& urine M-protein detectable by immunofixation but not on electrophoresis; or \>=90% reduction in serum \& urine M-protein level \<100mg/24h. PR: \>=50% reduction in serum M-protein \& reduction in 24h urinary M-protein by \>=90% or \<200 mg/24h. Analysis was performed using IPTW method to balance participant characteristics among reporting groups.
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
NUMBER
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 after application of IPTW method to raw numbers and is different from the actual participants included in the reporting arm.
reporting Status
POSTED
time Frame
From index date until first documentation of progression, death, or the start of new anticancer therapy (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
Objective Response Rate-Comparison Between Elranatamab in Study C1071003 Cohort A and COTA Cohort Using Inverse Probability of Treatment Weights (IPTW) Analysis
type
PRIMARY
unit Of Measure
Percentage of participants

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