TriangleNCT03615326 · OUTCOME
Progression Free Survival (PFS) Per RECIST 1.1 Assessed by 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
- Up to 46 months
What was measured
PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 as assessed by BICR or death due to any cause, whichever occurs first. Per RECIST 1.1, progressive disease (PD) is defined as at least a 20% 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 mm. The appearance of one or more new lesions is also considered progression. PFS was determined for first course pembrolizumab in the Global Cohort. Per statistical analysis plan, participants in the Japan-specific SOX Cohort were not included in the efficacy analysis.
Analysis population: All randomized Global Cohort participants in the Pembrolizumab First Course arm and SOC arm were included in this analysis. Per statistical analysis plan, participants in the Japan-specific SOX Cohort were not included in the efficacy analysis.
Groups in this outcome
Global Pembrolizumab + Standard of Care First Course
Participants received 200 mg pembrolizumab IV every 3 weeks (Q3W) plus trastuzumab (8 mg/kg loading dose, 6 mg/kg maintenance thereafter) IV Q3W in combination with FP or CAPOX chemotherapy.
Global Standard of Care
Participants received matched placebo to pembrolizumab IV Q3W plus trastuzumab (8mg/kg loading dose, 6mg/kg maintenance thereafter) IV Q3W in combination with FP or CAPOX chemotherapy.
| Group | Source count |
|---|---|
| Global Pembrolizumab + Standard of Care First Course | 350 |
| Global Standard of Care | 348 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Global Pembrolizumab + Standard of Care First Course | 10.0 | Not reported | 8.6 | 12.2 | Not reported |
| Global Standard of Care | 8.1 | Not reported | 7.0 | 8.5 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.61
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.87
- estimate Comment
- Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region, PD-L1 status, and chemotherapy regimen with small strata collapsed.
- group Description
- PFS in all participants of the Global Pembrolizumab + SOC First Course was compared to PFS in all participants of the Global Standard of Care to address the hypothesis (pembrolizumab in combination with trastuzumab plus chemotherapy is superior to trastuzumab plus chemotherapy alone).
- group Ids
- OG000
- OG001
- non Inferiority Comment
- The hazard ratio (HR) and its 95% confidence interval (CI) were estimated using a stratified Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region, PD-L1 status (positive vs. negative) at baseline, and chemotherapy regimen (FP or CAPOX).
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0002
- param Type
- Hazard Ratio (HR)
- param Value
- 0.73
- statistical Comment
- One-sided p-value based on log-rank test stratified by geographic region, PD-L1 status, and chemotherapy regimen with small strata collapsed.
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.61
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.87
- estimate Comment
- Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region, PD-L1 status, and chemotherapy regimen with small strata collapsed.
- group Description
- PFS in all participants of the Global Pembrolizumab + SOC First Course was compared to PFS in all participants of the Global Standard of Care to address the hypothesis (pembrolizumab in combination with trastuzumab plus chemotherapy is superior to trastuzumab plus chemotherapy alone).
- group Ids
- OG000
- OG001
- non Inferiority Comment
- The hazard ratio (HR) and its 95% confidence interval (CI) were estimated using a stratified Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region, PD-L1 status (positive vs. negative) at baseline, and chemotherapy regimen (FP or CAPOX).
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0002
- param Type
- Hazard Ratio (HR)
- param Value
- 0.73
- statistical Comment
- One-sided p-value based on log-rank test stratified by geographic region, PD-L1 status, and chemotherapy regimen with small strata collapsed.
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 8.6
- upper Limit
- 12.2
- value
- 10.0
- group Id
- OG001
- lower Limit
- 7.0
- upper Limit
- 8.5
- value
- 8.1
- denoms
- counts
- group Id
- OG000
- value
- 350
- group Id
- OG001
- value
- 348
- units
- Participants
- description
- PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 as assessed by BICR or death due to any cause, whichever occurs first. Per RECIST 1.1, progressive disease (PD) is defined as at least a 20% 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 mm. The appearance of one or more new lesions is also considered progression. PFS was determined for first course pembrolizumab in the Global Cohort. Per statistical analysis plan, participants in the Japan-specific SOX Cohort were not included in the efficacy analysis.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received 200 mg pembrolizumab IV every 3 weeks (Q3W) plus trastuzumab (8 mg/kg loading dose, 6 mg/kg maintenance thereafter) IV Q3W in combination with FP or CAPOX chemotherapy.
- id
- OG000
- title
- Global Pembrolizumab + Standard of Care First Course
- description
- Participants received matched placebo to pembrolizumab IV Q3W plus trastuzumab (8mg/kg loading dose, 6mg/kg maintenance thereafter) IV Q3W in combination with FP or CAPOX chemotherapy.
- id
- OG001
- title
- Global Standard of Care
- param Type
- MEDIAN
- population Description
- All randomized Global Cohort participants in the Pembrolizumab First Course arm and SOC arm were included in this analysis. Per statistical analysis plan, participants in the Japan-specific SOX Cohort were not included in the efficacy analysis.
- reporting Status
- POSTED
- time Frame
- Up to 46 months
- title
- Progression Free Survival (PFS) Per RECIST 1.1 Assessed by BICR
- type
- PRIMARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice