TriangleNCT04209855 · OUTCOME
Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
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 randomization until PD or death, whichever occurred first (up to approximately 36 months)
What was measured
PFS was defined as the time from randomization until progressive disease (PD) or death whichever occurred first. PD: At least a 20% increase in the sum of the longest diameters (SoD) of target lesion, taken as reference the smallest (nadir) SoD since and including baseline. In addition to the relative increase of 20%, the SoD must also demonstrate an absolute increase of at least 5 millimeters (mm). Unequivocal progression of non-target lesions and appearance of new lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.
Analysis population: The ITT population included all participants randomized to the study, regardless of whether or not participants received study treatment (MIRV or IC Chemo).
Groups in this outcome
Mirvetuximab Soravtansine
Participants randomized to single-agent MIRV at 6 mg/kg AIBW administered IV on Day 1 of Q3W.
Investigator's Choice (IC) Chemotherapy
Participants randomized to IC chemotherapeutic agent calculated using BSA. Paclitaxel administered at 80 mg/m\^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 of a 4-week cycle; or topotecan administered at 4 mg/m\^2 over 30 minutes on Days 1, 8, and 15 of a 4-week cycle. Alternatively, topotecan could have been administered at 1.25 mg/m\^2 over 30 minutes on Days 1 to 5 of a 3-week cycle; or pegylated liposomal doxorubicin administered at 40 mg/m\^2 as a 1 mg/minute IV infusion on Day 1 of a 4-week cycle. After Cycle 1, if tolerated, pegylated liposomal doxorubicin could have been administered as a 1-hour infusion.
| Group | Source count |
|---|---|
| Mirvetuximab Soravtansine | 227 |
| Investigator's Choice (IC) Chemotherapy | 226 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Mirvetuximab Soravtansine | 5.59 | Not reported | 4.34 | 5.88 | Not reported |
| Investigator's Choice (IC) Chemotherapy | 3.98 | Not reported | 2.86 | 4.47 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.513
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.785
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- param Type
- Cox Proportional Hazard
- param Value
- 0.63
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.513
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.785
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- param Type
- Cox Proportional Hazard
- param Value
- 0.63
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 4.34
- upper Limit
- 5.88
- value
- 5.59
- group Id
- OG001
- lower Limit
- 2.86
- upper Limit
- 4.47
- value
- 3.98
- denoms
- counts
- group Id
- OG000
- value
- 227
- group Id
- OG001
- value
- 226
- units
- Participants
- description
- PFS was defined as the time from randomization until progressive disease (PD) or death whichever occurred first. PD: At least a 20% increase in the sum of the longest diameters (SoD) of target lesion, taken as reference the smallest (nadir) SoD since and including baseline. In addition to the relative increase of 20%, the SoD must also demonstrate an absolute increase of at least 5 millimeters (mm). Unequivocal progression of non-target lesions and appearance of new lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants randomized to single-agent MIRV at 6 mg/kg AIBW administered IV on Day 1 of Q3W.
- id
- OG000
- title
- Mirvetuximab Soravtansine
- description
- Participants randomized to IC chemotherapeutic agent calculated using BSA. Paclitaxel administered at 80 mg/m\^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 of a 4-week cycle; or topotecan administered at 4 mg/m\^2 over 30 minutes on Days 1, 8, and 15 of a 4-week cycle. Alternatively, topotecan could have been administered at 1.25 mg/m\^2 over 30 minutes on Days 1 to 5 of a 3-week cycle; or pegylated liposomal doxorubicin administered at 40 mg/m\^2 as a 1 mg/minute IV infusion on Day 1 of a 4-week cycle. After Cycle 1, if tolerated, pegylated liposomal doxorubicin could have been administered as a 1-hour infusion.
- id
- OG001
- title
- Investigator's Choice (IC) Chemotherapy
- param Type
- MEDIAN
- population Description
- The ITT population included all participants randomized to the study, regardless of whether or not participants received study treatment (MIRV or IC Chemo).
- reporting Status
- POSTED
- time Frame
- From randomization until PD or death, whichever occurred first (up to approximately 36 months)
- title
- Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
- type
- PRIMARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice