NCT05565391 · OUTCOME

Duration of Response (DOR)-Unweighted 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 \[absolute increase \>=200mg/24h\]).

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.

Flatiron Health 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 Flatiron Health 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

Group	Source count
Study C1071003 Cohort A	75
COTA Cohort	73
Flatiron Health Cohort	46

Reported measurements

Source class 1

Values in Months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Study C1071003 Cohort A	NA	Not reported	11.99	NA	Median and upper limit of 95% CI could not be calculated due to insufficient number of participants with events.
COTA Cohort	4.37	Not reported	2.86	8.05	Not reported
Flatiron Health Cohort	7.16	Not reported	4.99	13.60	Not reported

Source statistical analyses

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

ci Lower Limit
0.09
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.31
estimate Comment
Hazard ratio was estimated using unadjusted Cox proportional hazard model.
group Ids
OG000
OG001
non Inferiority Type
OTHER
p Value
<.0001
param Type
Hazard Ratio (HR)
param Value
0.17
statistical Method
Cox proportional hazard model
ci Lower Limit
0.11
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.43
estimate Comment
Hazard ratio was estimated using unadjusted Cox proportional hazard model.
group Ids
OG000
OG002
non Inferiority Type
OTHER
p Value
<.0001
param Type
Hazard Ratio (HR)
param Value
0.22
statistical Method
Cox proportional hazard model

Complete source fields

analyses

ci Lower Limit
0.09
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.31
estimate Comment
Hazard ratio was estimated using unadjusted Cox proportional hazard model.
group Ids
OG000
OG001
non Inferiority Type
OTHER
p Value
<.0001
param Type
Hazard Ratio (HR)
param Value
0.17
statistical Method
Cox proportional hazard model
ci Lower Limit
0.11
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.43
estimate Comment
Hazard ratio was estimated using unadjusted Cox proportional hazard model.
group Ids
OG000
OG002
non Inferiority Type
OTHER
p Value
<.0001
param Type
Hazard Ratio (HR)
param Value
0.22
statistical Method
Cox proportional hazard model

classes

categories
measurements
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
group Id
OG001
lower Limit
2.86
upper Limit
8.05
value
4.37
group Id
OG002
lower Limit
4.99
upper Limit
13.60
value
7.16

denoms

counts
group Id
OG000
value
75
group Id
OG001
value
73
group Id
OG002
value
46
units
Participants

description

dispersion Type

95% Confidence Interval

groups

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
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
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 Flatiron Health database were included.
id
OG002
title
Flatiron Health 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 (DOR)-Unweighted Analysis

type

SECONDARY

unit Of Measure

Months

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Preserved source evidence · Not medical advice