Multiple Myeloma
Conditions
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
BCMA-CD3 bispecific antibody
Standard of care
Sponsors
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR)-Unweighted Analysis | 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) | 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) Analysis | 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) | 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 Analysis | 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) | 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
| Measure | Time frame | Description |
|---|---|---|
| Duration of Response (DOR)-Unweighted Analysis | 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) | 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 Analysis | 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) | 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 Analysis | 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) | 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 Analysis | 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) | 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 Analysis | 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) | 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 Analysis | 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) | 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
| Arm | Count |
|---|---|
| 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 |
| Total | 508 |
Baseline characteristics
| Characteristic | Study C1071003 Cohort A | COTA Cohort | Flatiron Health Cohort | Total |
|---|---|---|---|---|
| Age, Customized <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized >18 years | 123 Participants | 233 Participants | 152 Participants | 508 Participants |
| Race/Ethnicity, Customized Non-white | 51 Participants | 63 Participants | 50 Participants | 164 Participants |
| Race/Ethnicity, Customized White | 72 Participants | 170 Participants | 102 Participants | 344 Participants |
| Sex: Female, Male Female | 55 Participants | 107 Participants | 72 Participants | 234 Participants |
| Sex: Female, Male Male | 68 Participants | 126 Participants | 80 Participants | 274 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Study C1071003 Cohort A | Objective Response Rate-Comparison Between Elranatamab in Study C1071003 Cohort A and COTA Cohort Using Inverse Probability of Treatment Weights (IPTW) Analysis | 75.7 Percentage of participants |
| COTA Cohort | Objective Response Rate-Comparison Between Elranatamab in Study C1071003 Cohort A and COTA Cohort Using Inverse Probability of Treatment Weights (IPTW) Analysis | 34.2 Percentage of participants |
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Study C1071003 Cohort A | Objective Response Rate-Comparison Between Elranatamab in Study C1071003 Cohort A and Flatiron Health Cohort Using IPTW Analysis | 56.0 Percentage of participants |
| COTA Cohort | Objective Response Rate-Comparison Between Elranatamab in Study C1071003 Cohort A and Flatiron Health Cohort Using IPTW Analysis | 31.3 Percentage of participants |
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Study C1071003 Cohort A | Objective Response Rate (ORR)-Unweighted Analysis | 61.0 Percentage of participants |
| COTA Cohort | Objective Response Rate (ORR)-Unweighted Analysis | 31.3 Percentage of participants |
| Flatiron Health Cohort | Objective Response Rate (ORR)-Unweighted Analysis | 30.3 Percentage of participants |
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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Study C1071003 Cohort A | Duration of Response-Comparison Between Elranatamab in Study C1071003 Cohort A and COTA Cohort Using IPTW Analysis | NA Months |
| COTA Cohort | Duration of Response-Comparison Between Elranatamab in Study C1071003 Cohort A and COTA Cohort Using IPTW Analysis | 4.37 Months |
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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Study C1071003 Cohort A | Duration of Response-Comparison Between Elranatamab in Study C1071003 Cohort A and Flatiron Health Cohort Using IPTW Analysis | NA Months |
| COTA Cohort | Duration of Response-Comparison Between Elranatamab in Study C1071003 Cohort A and Flatiron Health Cohort Using IPTW Analysis | 7.16 Months |
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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Study C1071003 Cohort A | Duration of Response (DOR)-Unweighted Analysis | NA Months |
| COTA Cohort | Duration of Response (DOR)-Unweighted Analysis | 4.37 Months |
| Flatiron Health Cohort | Duration of Response (DOR)-Unweighted Analysis | 7.16 Months |
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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Study C1071003 Cohort A | Time to Response-Comparison Between Elranatamab in Study C1071003 Cohort A and Flatiron Health Cohort Using IPTW Analysis | 1.15 Months |
| COTA Cohort | Time to Response-Comparison Between Elranatamab in Study C1071003 Cohort A and Flatiron Health Cohort Using IPTW Analysis | 1.87 Months |
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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Study C1071003 Cohort A | Time to Response (TTR)-Comparison Between Elranatamab in Study C1071003 Cohort A and COTA Cohort Using IPTW Analysis | 1.25 months |
| COTA Cohort | Time to Response (TTR)-Comparison Between Elranatamab in Study C1071003 Cohort A and COTA Cohort Using IPTW Analysis | 1.18 months |
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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Study C1071003 Cohort A | Time to Response (TTR)-Unweighted Analysis | 1.22 Months |
| COTA Cohort | Time to Response (TTR)-Unweighted Analysis | 1.38 Months |
| Flatiron Health Cohort | Time to Response (TTR)-Unweighted Analysis | 1.87 Months |