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A Study to Learn About the Medicine (Called Elranatamab) in People With Relapsed Refractory Multiple Myeloma

Comparative Effectiveness of Elranatamab (PF 06863135) in Clinical Study C1071003 Versus Standard of Care (SOC) in Real-World (RW) External Control Arms in Patients With Triple-Class Refractory (TCR) Multiple Myeloma (MM)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05565391
Enrollment
508
Registered
2022-10-04
Start date
2022-10-03
Completion date
2022-11-04
Last updated
2024-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma

Keywords

Myeloma, Multiple Myeloma, relapsed Multiple Myeloma, refractory Multiple Myeloma, PF-06863135, BCMA, bispecific, bispecific antibody, BCMA-CD3 bispecific, Elranatamab, MagnetisMM-3

Brief summary

This study is to understand how well elranatamab (PF-06863135) may be used for relapsed refractory multiple myeloma (RRMM). Sometimes MM might improve at first, but then gets resistant to the treatment and starts growing again (known as relapsed refractory). This study medicine will be compared with standard-of-care (SOC) therapies used in real-world clinical practice. For people receiving elranatamab, we will use data from the phase 2 clinical trial (MagnetisMM-3). We will also use data from two real-world databases, representing the SOC in clinical practice. This study does not seek any participants for enrollment. We will compare the experiences of people receiving elranatamab to people receiving SOC therapies. This way, it will help us to know how well elranatamab can be used for RRMM treatment.

Interventions

DRUGElranatamab

BCMA-CD3 bispecific antibody

DRUGStandard of care

Standard of care

Sponsors

Pfizer
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Aged 18 years and older at index date * Diagnosis of MM * Measurable disease according to IMWG criteria * ECOG performance status ≤2 * Refractory to at least 1 proteasome inhibitor, 1 immunomodulatory drug, and 1 anti-CD38 treatment (ie, triple-class refractory \[TCR\]) * At least 1 treatment following their TCR eligibility

Exclusion criteria

* Acute plasma cell leukemia * Amyloidosis * Smoldering MM * Stem cell transplant within 12 weeks of index or active graft versus host disease (GVHD) * Active malignancy within 3 years before index, except for basal cell or squamous cell skin cancer or carcinoma in situ * Administration with an investigational drug within 30 days prior to index

Design outcomes

Primary

MeasureTime frameDescription
Objective Response Rate (ORR)-Unweighted AnalysisFrom 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)ORR was the percentage of participants with objective response (OR) per IMWG criteria. For the analysis set of participants from Study C1071003 and COTA, OR was partial response (PR) or better (stringent complete response \[sCR\]+complete response \[CR\]+very good partial response \[VGPR\]+PR). For Study C1071003 and Flatiron Health, OR was 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. Clopper-Pearson two-sided 95% exact confidence intervals were estimated.
Objective Response Rate-Comparison Between Elranatamab in Study C1071003 Cohort A and COTA Cohort Using Inverse Probability of Treatment Weights (IPTW) AnalysisFrom 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)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.
Objective Response Rate-Comparison Between Elranatamab in Study C1071003 Cohort A and Flatiron Health Cohort Using IPTW AnalysisFrom 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)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.

Secondary

MeasureTime frameDescription
Duration of Response (DOR)-Unweighted AnalysisFrom 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)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 \[absolute increase \>=200mg/24h\]).
Time to Response (TTR)-Unweighted AnalysisFrom index date to date of first documentation of OR (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)TTR was defined as the time from the index date to the first documentation of OR. No censoring was performed. OR is defined as having a best overall response (BOR) of confirmed sCR, CR, VGPR or PR per IMWG criteria.
Duration of Response-Comparison Between Elranatamab in Study C1071003 Cohort A and Flatiron Health Cohort Using IPTW AnalysisFrom 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)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.
Duration of Response-Comparison Between Elranatamab in Study C1071003 Cohort A and COTA Cohort Using IPTW AnalysisFrom 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)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.
Time to Response (TTR)-Comparison Between Elranatamab in Study C1071003 Cohort A and COTA Cohort Using IPTW AnalysisFrom index date to date of first documentation of OR (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)TTR was defined as the time from the index date to the first documentation of OR. OR is defined as having a best overall response (BOR) of confirmed sCR, CR, VGPR or PR per IMWG criteria. Analysis was performed using IPTW method to balance participant characteristics among reporting groups.
Time to Response-Comparison Between Elranatamab in Study C1071003 Cohort A and Flatiron Health Cohort Using IPTW AnalysisFrom index date to date of first documentation of OR (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)TTR was defined as the time from the index date to the first documentation of OR. OR is defined as having a best overall response (BOR) of confirmed sCR, CR, VGPR or PR per IMWG criteria. Analysis was performed using IPTW method to balance participant characteristics among reporting groups.

Countries

United States

Participant flow

Recruitment details

This retrospective cohort study included triple-class refractory (TCR) multiple myeloma (MM) participants who initiated elranatamab in study C1071003 (NCT04649359) and 2 cohorts of real-world (RW) TCR MM participants who initiated standard of care (SOC) treatment identified from Flatiron Health and COTA databases as external control arms for Study C1071003.

Pre-assignment details

Index date was defined as the date of initiation of the first regimen after TCR MM eligibility. Only participants with an index date between 16-Nov-2015 and 31-Mar-2022 were selected. Participants were observed from the index date to the earliest of death, or the latest available participants record, whichever occurred first.

Participants by arm

ArmCount
Study C1071003 Cohort A
Participants with TCR MM who initiated elranatamab (PF-06863135) following TCR eligibility in study C1071003 (NCT04649359) were included.
123
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.
233
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.
152
Total508

Baseline characteristics

CharacteristicStudy C1071003 Cohort ACOTA CohortFlatiron Health CohortTotal
Age, Customized
<=18 years
0 Participants0 Participants0 Participants0 Participants
Age, Customized
>18 years
123 Participants233 Participants152 Participants508 Participants
Race/Ethnicity, Customized
Non-white
51 Participants63 Participants50 Participants164 Participants
Race/Ethnicity, Customized
White
72 Participants170 Participants102 Participants344 Participants
Sex: Female, Male
Female
55 Participants107 Participants72 Participants234 Participants
Sex: Female, Male
Male
68 Participants126 Participants80 Participants274 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 00 / 00 / 0
other
Total, other adverse events
0 / 00 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 00 / 0

Outcome results

Primary

Objective Response Rate-Comparison Between Elranatamab in Study C1071003 Cohort A and COTA Cohort Using Inverse Probability of Treatment Weights (IPTW) Analysis

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.

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)

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.

ArmMeasureValue (NUMBER)
Study C1071003 Cohort AObjective Response Rate-Comparison Between Elranatamab in Study C1071003 Cohort A and COTA Cohort Using Inverse Probability of Treatment Weights (IPTW) Analysis75.7 Percentage of participants
COTA CohortObjective Response Rate-Comparison Between Elranatamab in Study C1071003 Cohort A and COTA Cohort Using Inverse Probability of Treatment Weights (IPTW) Analysis34.2 Percentage of participants
p-value: <0.000195% CI: [1.69, 2.9]Log-binomial regression model
Primary

Objective Response Rate-Comparison Between Elranatamab in Study C1071003 Cohort A and Flatiron Health Cohort Using IPTW Analysis

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.

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)

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.

ArmMeasureValue (NUMBER)
Study C1071003 Cohort AObjective Response Rate-Comparison Between Elranatamab in Study C1071003 Cohort A and Flatiron Health Cohort Using IPTW Analysis56.0 Percentage of participants
COTA CohortObjective Response Rate-Comparison Between Elranatamab in Study C1071003 Cohort A and Flatiron Health Cohort Using IPTW Analysis31.3 Percentage of participants
p-value: 0.044795% CI: [1.01, 3.15]Log-binomial regression model
Primary

Objective Response Rate (ORR)-Unweighted Analysis

ORR was the percentage of participants with objective response (OR) per IMWG criteria. For the analysis set of participants from Study C1071003 and COTA, OR was partial response (PR) or better (stringent complete response \[sCR\]+complete response \[CR\]+very good partial response \[VGPR\]+PR). For Study C1071003 and Flatiron Health, OR was 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. Clopper-Pearson two-sided 95% exact confidence intervals were estimated.

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)

Population: Eligible participants from study C1071003 (Cohort A) and RW participants identified from COTA and Flatiron Health databases were included.

ArmMeasureValue (NUMBER)
Study C1071003 Cohort AObjective Response Rate (ORR)-Unweighted Analysis61.0 Percentage of participants
COTA CohortObjective Response Rate (ORR)-Unweighted Analysis31.3 Percentage of participants
Flatiron Health CohortObjective Response Rate (ORR)-Unweighted Analysis30.3 Percentage of participants
p-value: <0.000195% CI: [1.54, 2.47]Log-binomial regression model
p-value: <0.000195% CI: [1.52, 2.67]Log-binomial regression model
Secondary

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

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.

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)

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.

ArmMeasureValue (MEDIAN)
Study C1071003 Cohort ADuration of Response-Comparison Between Elranatamab in Study C1071003 Cohort A and COTA Cohort Using IPTW AnalysisNA Months
COTA CohortDuration of Response-Comparison Between Elranatamab in Study C1071003 Cohort A and COTA Cohort Using IPTW Analysis4.37 Months
p-value: <0.000195% CI: [0.06, 0.22]Cox proportional hazard model
Secondary

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

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.

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)

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.

ArmMeasureValue (MEDIAN)
Study C1071003 Cohort ADuration of Response-Comparison Between Elranatamab in Study C1071003 Cohort A and Flatiron Health Cohort Using IPTW AnalysisNA Months
COTA CohortDuration of Response-Comparison Between Elranatamab in Study C1071003 Cohort A and Flatiron Health Cohort Using IPTW Analysis7.16 Months
p-value: <0.000195% CI: [0.1, 0.45]Weighted Cox proportional hazard model
Secondary

Duration of Response (DOR)-Unweighted Analysis

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 \[absolute increase \>=200mg/24h\]).

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)

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.

ArmMeasureValue (MEDIAN)
Study C1071003 Cohort ADuration of Response (DOR)-Unweighted AnalysisNA Months
COTA CohortDuration of Response (DOR)-Unweighted Analysis4.37 Months
Flatiron Health CohortDuration of Response (DOR)-Unweighted Analysis7.16 Months
p-value: <0.000195% CI: [0.09, 0.31]Cox proportional hazard model
p-value: <0.000195% CI: [0.11, 0.43]Cox proportional hazard model
Secondary

Time to Response-Comparison Between Elranatamab in Study C1071003 Cohort A and Flatiron Health Cohort Using IPTW Analysis

TTR was defined as the time from the index date to the first documentation of OR. OR is defined as having a best overall response (BOR) of confirmed sCR, CR, VGPR or PR per IMWG criteria. Analysis was performed using IPTW method to balance participant characteristics among reporting groups.

Time frame: From index date to date of first documentation of OR (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)

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.

ArmMeasureValue (MEDIAN)
Study C1071003 Cohort ATime to Response-Comparison Between Elranatamab in Study C1071003 Cohort A and Flatiron Health Cohort Using IPTW Analysis1.15 Months
COTA CohortTime to Response-Comparison Between Elranatamab in Study C1071003 Cohort A and Flatiron Health Cohort Using IPTW Analysis1.87 Months
p-value: 0.0326Quantile regression
Secondary

Time to Response (TTR)-Comparison Between Elranatamab in Study C1071003 Cohort A and COTA Cohort Using IPTW Analysis

TTR was defined as the time from the index date to the first documentation of OR. OR is defined as having a best overall response (BOR) of confirmed sCR, CR, VGPR or PR per IMWG criteria. Analysis was performed using IPTW method to balance participant characteristics among reporting groups.

Time frame: From index date to date of first documentation of OR (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)

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.

ArmMeasureValue (MEDIAN)
Study C1071003 Cohort ATime to Response (TTR)-Comparison Between Elranatamab in Study C1071003 Cohort A and COTA Cohort Using IPTW Analysis1.25 months
COTA CohortTime to Response (TTR)-Comparison Between Elranatamab in Study C1071003 Cohort A and COTA Cohort Using IPTW Analysis1.18 months
p-value: 0.7682Quantile regression
Secondary

Time to Response (TTR)-Unweighted Analysis

TTR was defined as the time from the index date to the first documentation of OR. No censoring was performed. OR is defined as having a best overall response (BOR) of confirmed sCR, CR, VGPR or PR per IMWG criteria.

Time frame: From index date to date of first documentation of OR (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)

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.

ArmMeasureValue (MEDIAN)
Study C1071003 Cohort ATime to Response (TTR)-Unweighted Analysis1.22 Months
COTA CohortTime to Response (TTR)-Unweighted Analysis1.38 Months
Flatiron Health CohortTime to Response (TTR)-Unweighted Analysis1.87 Months
p-value: 0.4241Quantile regression
p-value: 0.0281Quantile regression

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026