TriangleNCT02358031 · OUTCOME
Pembro Combo vs Control: OS in Participants With PD-L1 CPS ≥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
- Up to approximately 47 months
What was measured
OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. Per protocol, OS in the pembro combo arm was compared to the control arm as a pre-specified primary analysis of the ITT population. OS is reported here for the first course of treatment, for all participants in the pembro combo arm and control arm with PD-L1 biomarker positive expression defined by IHC as CPS ≥1. Per protocol, OS was compared separately between CPS ≥1 participants of the pembro mono arm and control arm and is presented later in the record.
Analysis population: Participants in the ITT population randomized to either pembro combo arm or control arm during active enrollment with CPS ≥1 were analyzed. 20 participants in control arm enrolled during an enrollment pause of the pembro combo arm were excluded. Per protocol, pembro mono arm was compared to control arm separately and not included in this analysis.
Groups in this outcome
Pembrolizumab Monotherapy (Pembro Mono)
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for up to 35 cycles (up to \~2 years).
Pembrolizumab + Chemotherapy (Pembro Combo)
Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 35 cycles (up to \~2 years); plus cisplatin 100 mg/m\^2 IV or carboplatin at a target area under the curve of 5 (AUC 5) IV, per Investigator's choice, on Day 1 of each 3-week cycle (6 cycle maximum \[up to \~4 months\]); plus 5-Fluorouracil (5-FU) 1000 mg/m\^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum \[up to \~4 months\]).
Cetuximab + Chemotherapy (Control)
Participants received cetuximab on Day 1 at a dose of 400 mg/m\^2 IV, and then 250 mg/m\^2 IV on Day 1 of each subsequent week until disease progression or unacceptable toxicity; plus cisplatin 100 mg/m\^2 IV or carboplatin AUC 5 IV (Investigator's choice) on Day 1 of each 3-week cycle (6 cycle maximum \[up to \~4 months\] for platinum-based therapy); plus 5-FU 1000 mg/m\^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum \[up to \~4 months\]).
| Group | Source count |
|---|---|
| Pembrolizumab Monotherapy (Pembro Mono) | 0 |
| Pembrolizumab + Chemotherapy (Pembro Combo) | 242 |
| Cetuximab + Chemotherapy (Control) | 235 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pembrolizumab + Chemotherapy (Pembro Combo) | 13.6 | Not reported | 10.7 | 15.5 | Not reported |
| Cetuximab + Chemotherapy (Control) | 10.4 | Not reported | 9.1 | 11.7 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.53
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.80
- group Description
- OS in CPS ≥1 participants of the pembro combo arm was compared to OS in CPS ≥1 participants of the control arm to address the twelfth primary hypothesis. The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG, HPV status and PD-L1 status.
- group Ids
- OG001
- OG002
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.00002
- p Value Comment
- One-sided p-value based on log-rank test stratified by ECOG, HPV status and PD-L1 status.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.65
- statistical Method
- Regression, Cox
Complete source fields
- analyses
- ci Lower Limit
- 0.53
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.80
- group Description
- OS in CPS ≥1 participants of the pembro combo arm was compared to OS in CPS ≥1 participants of the control arm to address the twelfth primary hypothesis. The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG, HPV status and PD-L1 status.
- group Ids
- OG001
- OG002
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.00002
- p Value Comment
- One-sided p-value based on log-rank test stratified by ECOG, HPV status and PD-L1 status.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.65
- statistical Method
- Regression, Cox
- classes
- categories
- measurements
- group Id
- OG001
- lower Limit
- 10.7
- upper Limit
- 15.5
- value
- 13.6
- group Id
- OG002
- lower Limit
- 9.1
- upper Limit
- 11.7
- value
- 10.4
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 242
- group Id
- OG002
- value
- 235
- units
- Participants
- description
- OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. Per protocol, OS in the pembro combo arm was compared to the control arm as a pre-specified primary analysis of the ITT population. OS is reported here for the first course of treatment, for all participants in the pembro combo arm and control arm with PD-L1 biomarker positive expression defined by IHC as CPS ≥1. Per protocol, OS was compared separately between CPS ≥1 participants of the pembro mono arm and control arm and is presented later in the record.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for up to 35 cycles (up to \~2 years).
- id
- OG000
- title
- Pembrolizumab Monotherapy (Pembro Mono)
- description
- Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 35 cycles (up to \~2 years); plus cisplatin 100 mg/m\^2 IV or carboplatin at a target area under the curve of 5 (AUC 5) IV, per Investigator's choice, on Day 1 of each 3-week cycle (6 cycle maximum \[up to \~4 months\]); plus 5-Fluorouracil (5-FU) 1000 mg/m\^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum \[up to \~4 months\]).
- id
- OG001
- title
- Pembrolizumab + Chemotherapy (Pembro Combo)
- description
- Participants received cetuximab on Day 1 at a dose of 400 mg/m\^2 IV, and then 250 mg/m\^2 IV on Day 1 of each subsequent week until disease progression or unacceptable toxicity; plus cisplatin 100 mg/m\^2 IV or carboplatin AUC 5 IV (Investigator's choice) on Day 1 of each 3-week cycle (6 cycle maximum \[up to \~4 months\] for platinum-based therapy); plus 5-FU 1000 mg/m\^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum \[up to \~4 months\]).
- id
- OG002
- title
- Cetuximab + Chemotherapy (Control)
- param Type
- MEDIAN
- population Description
- Participants in the ITT population randomized to either pembro combo arm or control arm during active enrollment with CPS ≥1 were analyzed. 20 participants in control arm enrolled during an enrollment pause of the pembro combo arm were excluded. Per protocol, pembro mono arm was compared to control arm separately and not included in this analysis.
- reporting Status
- POSTED
- time Frame
- Up to approximately 47 months
- title
- Pembro Combo vs Control: OS in Participants With PD-L1 CPS ≥1
- type
- PRIMARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice