TriangleNCT02494583 · OUTCOME
Pembro Mono vs SOC: PFS Per RECIST 1.1 by BICR in Participants With PD-L1 CPS ≥1 (All Participants)
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 approximately 42 months
What was measured
PFS was defined as the time from randomization to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. Per protocol, PFS in the pembro mono arm was compared to the SOC arm as a pre-specified secondary analysis of the ITT population. PFS is reported here for all participants in the pembro mono arm and SOC arm who were PD-L1 CPS ≥1 (all participants). Per protocol, PFS was compared separately between CPS ≥1 participants of the pembro combo arm and SOC arm and is presented earlier in the record.
Analysis population: All CPS ≥1 participants in the ITT population randomized to the pembro mono arm and SOC arm were analyzed. Per protocol, the pembro combo arm was compared to the SOC arm separately and not included in this analysis.
Groups in this outcome
Pembrolizumab Monotherapy (Pembro Mono)
Participants received pembrolizumab 200 mg IV Q3W.
Pembrolizumab + SOC Chemotherapy (Pembro Combo)
Participants received pembrolizumab 200 mg Q3W plus cisplatin 80 mg/m\^2 Q3W plus 5-FU 800 mg/m\^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m\^2 twice a day (BID) on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.
Placebo + SOC Chemotherapy (SOC)
Participants received placebo IV Q3W plus cisplatin 80 mg/m\^2 Q3W plus 5-FU 800 mg/m\^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m\^2 BID on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.
| Group | Source count |
|---|---|
| Pembrolizumab Monotherapy (Pembro Mono) | 256 |
| Pembrolizumab + SOC Chemotherapy (Pembro Combo) | 0 |
| Placebo + SOC Chemotherapy (SOC) | 250 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pembrolizumab Monotherapy (Pembro Mono) | 2.0 | Not reported | 1.5 | 2.8 | Not reported |
| Placebo + SOC Chemotherapy (SOC) | 6.4 | Not reported | 5.7 | 7.1 | Not reported |
Source statistical analyses
- ci Lower Limit
- 1.36
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.98
- estimate Comment
- Since stratified analyses could be based on collapsing strata with insufficient number of participants or events, strata were pooled in some cases based on clinical judgement and actual counts.
- group Description
- PFS in CPS ≥1 participants of the pembro mono arm was compared to PFS in CPS ≥1 participants of the SOC arm based on a Cox regression model with Efron's method of tie handling with treatment as a covariate with stratification according to geographic region, disease status, and fluoropyrimidine treatment.
- group Ids
- OG000
- OG002
- non Inferiority Type
- OTHER
- p Value
- 1.00000
- p Value Comment
- No formal hypothesis testing performed; nominal p-value provided for treatment comparison.
- param Type
- Hazard Ratio (HR)
- param Value
- 1.64
- statistical Method
- Regression, Cox
Complete source fields
- analyses
- ci Lower Limit
- 1.36
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.98
- estimate Comment
- Since stratified analyses could be based on collapsing strata with insufficient number of participants or events, strata were pooled in some cases based on clinical judgement and actual counts.
- group Description
- PFS in CPS ≥1 participants of the pembro mono arm was compared to PFS in CPS ≥1 participants of the SOC arm based on a Cox regression model with Efron's method of tie handling with treatment as a covariate with stratification according to geographic region, disease status, and fluoropyrimidine treatment.
- group Ids
- OG000
- OG002
- non Inferiority Type
- OTHER
- p Value
- 1.00000
- p Value Comment
- No formal hypothesis testing performed; nominal p-value provided for treatment comparison.
- param Type
- Hazard Ratio (HR)
- param Value
- 1.64
- statistical Method
- Regression, Cox
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.5
- upper Limit
- 2.8
- value
- 2.0
- group Id
- OG002
- lower Limit
- 5.7
- upper Limit
- 7.1
- value
- 6.4
- denoms
- counts
- group Id
- OG000
- value
- 256
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 250
- units
- Participants
- description
- PFS was defined as the time from randomization to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. Per protocol, PFS in the pembro mono arm was compared to the SOC arm as a pre-specified secondary analysis of the ITT population. PFS is reported here for all participants in the pembro mono arm and SOC arm who were PD-L1 CPS ≥1 (all participants). Per protocol, PFS was compared separately between CPS ≥1 participants of the pembro combo arm and SOC arm and is presented earlier in the record.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received pembrolizumab 200 mg IV Q3W.
- id
- OG000
- title
- Pembrolizumab Monotherapy (Pembro Mono)
- description
- Participants received pembrolizumab 200 mg Q3W plus cisplatin 80 mg/m\^2 Q3W plus 5-FU 800 mg/m\^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m\^2 twice a day (BID) on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.
- id
- OG001
- title
- Pembrolizumab + SOC Chemotherapy (Pembro Combo)
- description
- Participants received placebo IV Q3W plus cisplatin 80 mg/m\^2 Q3W plus 5-FU 800 mg/m\^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m\^2 BID on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.
- id
- OG002
- title
- Placebo + SOC Chemotherapy (SOC)
- param Type
- MEDIAN
- population Description
- All CPS ≥1 participants in the ITT population randomized to the pembro mono arm and SOC arm were analyzed. Per protocol, the pembro combo arm was compared to the SOC arm separately and not included in this analysis.
- reporting Status
- POSTED
- time Frame
- Up to approximately 42 months
- title
- Pembro Mono vs SOC: PFS Per RECIST 1.1 by BICR in Participants With PD-L1 CPS ≥1 (All Participants)
- type
- SECONDARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice