TriangleNCT04223856 · OUTCOME
Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 by Blinded Independent Central Review (BICR)
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 the date of randomization to first documentation of PD or death due to any cause, whichever occurred first (maximum exposure to treatment was up to 39.2 months)
What was measured
PFS was defined as the time from date of randomization to first documentation of disease progression (PD), or to death due to any cause, whichever occurred first. PD: at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). PD could also be unequivocal progression of non-target lesions or the presence of unequivocal new lesions. Kaplan-Meier method was used for analysis.
Analysis population: ITT analysis set included all randomized participants. Participants were analyzed according to the treatment arm assigned at randomization regardless of the actual treatment received.
Groups in this outcome
Enfortumab Vedotin + Pembrolizumab
Participants received enfortumab vedotin at 1.25 mg/kg as an IV infusion over approximately 30 minutes on Days 1 and 8 of each cycle, and pembrolizumab 200 mg as an IV infusion over approximately 30 minutes on Day 1 of each cycle, after completion of the enfortumab vedotin infusion. 1 cycle = 3 weeks.
Standard of Care
Participants received gemcitabine at 1000 mg/m\^2 as an IV infusion on Days 1 and 8 of each cycle, and either cisplatin (70 mg/m\^2) or carboplatin (AUC 4.5, or AUC 5 according to local guidelines) on Day 1 of each cycle, with adequate pre- and post-hydration, by IV infusion per institutional standards. 1 cycle = 3 weeks.
| Group | Source count |
|---|---|
| Enfortumab Vedotin + Pembrolizumab | 442 |
| Standard of Care | 444 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Enfortumab Vedotin + Pembrolizumab | 12.5 | Not reported | 10.4 | 16.6 | Not reported |
| Standard of Care | 6.3 | Not reported | 6.2 | 6.5 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.377
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.538
- estimate Comment
- HR was calculated using stratified Cox proportional hazards model.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.00001
- p Value Comment
- P value was calculated using stratified log-rank test. The p-value threshold for statistical significance is 0.005.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.450
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.377
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.538
- estimate Comment
- HR was calculated using stratified Cox proportional hazards model.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.00001
- p Value Comment
- P value was calculated using stratified log-rank test. The p-value threshold for statistical significance is 0.005.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.450
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 10.4
- upper Limit
- 16.6
- value
- 12.5
- group Id
- OG001
- lower Limit
- 6.2
- upper Limit
- 6.5
- value
- 6.3
- denoms
- counts
- group Id
- OG000
- value
- 442
- group Id
- OG001
- value
- 444
- units
- Participants
- description
- PFS was defined as the time from date of randomization to first documentation of disease progression (PD), or to death due to any cause, whichever occurred first. PD: at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). PD could also be unequivocal progression of non-target lesions or the presence of unequivocal new lesions. Kaplan-Meier method was used for analysis.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received enfortumab vedotin at 1.25 mg/kg as an IV infusion over approximately 30 minutes on Days 1 and 8 of each cycle, and pembrolizumab 200 mg as an IV infusion over approximately 30 minutes on Day 1 of each cycle, after completion of the enfortumab vedotin infusion. 1 cycle = 3 weeks.
- id
- OG000
- title
- Enfortumab Vedotin + Pembrolizumab
- description
- Participants received gemcitabine at 1000 mg/m\^2 as an IV infusion on Days 1 and 8 of each cycle, and either cisplatin (70 mg/m\^2) or carboplatin (AUC 4.5, or AUC 5 according to local guidelines) on Day 1 of each cycle, with adequate pre- and post-hydration, by IV infusion per institutional standards. 1 cycle = 3 weeks.
- id
- OG001
- title
- Standard of Care
- param Type
- MEDIAN
- population Description
- ITT analysis set included all randomized participants. Participants were analyzed according to the treatment arm assigned at randomization regardless of the actual treatment received.
- reporting Status
- POSTED
- time Frame
- From the date of randomization to first documentation of PD or death due to any cause, whichever occurred first (maximum exposure to treatment was up to 39.2 months)
- title
- Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 by Blinded Independent Central Review (BICR)
- type
- PRIMARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice