NCT06504524 · OUTCOME

PFS: C1071003 Cohort A Versus Flatiron Health Database Using IPTW Analysis

A Study to Compare the Effects of Elranatamab (PF 06863135) Versus Standard of Care (SOC) in Patients With Multiple Myeloma (MM) in Germany and US · Source last updated 2025-06-27

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: C1071003: First dose to PD or death due to any cause or censoring whichever occurred first (max follow-up of 2.09Y); Flatiron Health Database: SOC to PD or death due to any cause or censoring whichever occurred first (max follow-up of 6.45Y)

What was measured

PFS: A) C1071003 Cohort A: time from date of first dose of elranatamab until confirmed PD per IMWG criteria or death due to any cause, whichever occurred first. Participants censored at loss to or end of follow-up. B) Flatiron Health Database: time from SOC to either date of progression or death due to any cause. Participants censored at loss to follow-up or end of study period. PD per IMWG criteria: increase of \>=25% from lowest response value in any 1 or more of the criteria: SPEP with absolute increase \>0.5 g/dL; 24-hour UPEP with absolute increase \>200 mg/24 h; in participants without measurable serum and urine M-protein, absolute increase of \>10 mg/dL in difference between involved and uninvolved FLC level; or absolute bone marrow plasma cell percentage \>10%. Kaplan Meier method used for analysis. Retrospective data evaluated in this observational study for approximately 9 months.

Analysis population: Eligible participants whose data was retrieved and was used in this retrospective cohort study. In this outcome measure, IPTW analysis was applied. IPTW eliminated the effect of confounding by observed baseline participant characteristics, improve covariate balance, and thereby obtained unbiased estimates of treatment effects.

Groups in this outcome

C1071003 Cohort A

Eligible participants with TCR-MM, who were BCMA naïve, who initiated elranatamab (PF-06863135) following TCR eligibility in study C1071003 (NCT04649359) Cohort A were included.

RWD: Flatiron Health Database

Eligible participants with TCR-MM who initiated SOC treatment and were identified from Flatiron Health database in real world setting under routine clinical practice outside of clinical trials were included. This arm served as external control arm.

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
C1071003 Cohort A	118
RWD: Flatiron Health Database	238

Reported measurements

Source class 1

Values in Months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
C1071003 Cohort A	10.58	Not reported	3.42	NA	Upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
RWD: Flatiron Health Database	6.01	Not reported	4.53	7.26	Not reported

Source statistical analyses

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

ci Lower Limit
0.38
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.71
estimate Comment
IPTW HR were estimated using weighted Cox proportional hazard models and confidence intervals were estimated using robust error variances. Stabilized IPT weights truncated at the 99.5th percentile were used.
group Ids
OG000
OG001
non Inferiority Type
OTHER
p Value
=0.0011
param Type
Hazard Ratio (HR)
param Value
0.52
statistical Method
Regression, Cox

Complete source fields

analyses

ci Lower Limit
0.38
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.71
estimate Comment
IPTW HR were estimated using weighted Cox proportional hazard models and confidence intervals were estimated using robust error variances. Stabilized IPT weights truncated at the 99.5th percentile were used.
group Ids
OG000
OG001
non Inferiority Type
OTHER
p Value
=0.0011
param Type
Hazard Ratio (HR)
param Value
0.52
statistical Method
Regression, Cox

classes

categories
measurements
comment
Upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
group Id
OG000
lower Limit
3.42
upper Limit
NA
value
10.58
group Id
OG001
lower Limit
4.53
upper Limit
7.26
value
6.01

denoms

counts
group Id
OG000
value
118
group Id
OG001
value
238
units
Participants

description

dispersion Type

95% Confidence Interval

groups

description
Eligible participants with TCR-MM, who were BCMA naïve, who initiated elranatamab (PF-06863135) following TCR eligibility in study C1071003 (NCT04649359) Cohort A were included.
id
OG000
title
C1071003 Cohort A
description
Eligible participants with TCR-MM who initiated SOC treatment and were identified from Flatiron Health database in real world setting under routine clinical practice outside of clinical trials were included. This arm served as external control arm.
id
OG001
title
RWD: Flatiron Health Database

param Type

MEDIAN

population Description

Eligible participants whose data was retrieved and was used in this retrospective cohort study. In this outcome measure, IPTW analysis was applied. IPTW eliminated the effect of confounding by observed baseline participant characteristics, improve covariate balance, and thereby obtained unbiased estimates of treatment effects.

reporting Status

POSTED

time Frame

C1071003: First dose to PD or death due to any cause or censoring whichever occurred first (max follow-up of 2.09Y); Flatiron Health Database: SOC to PD or death due to any cause or censoring whichever occurred first (max follow-up of 6.45Y)

title

PFS: C1071003 Cohort A Versus Flatiron Health Database Using IPTW Analysis

type

SECONDARY

unit Of Measure

Months

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Preserved source evidence · Not medical advice