TriangleNCT02516241 · OUTCOME
PFS2, PD-L1-Low/Negative Analysis Set -Durvalumab + Tremelimumab Combination Therapy Versus SoC and Durvalumab + Tremelimumab Combination Therapy Versus Durvalumab Monotherapy
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
- Tumour scans performed at baseline then every 8 weeks since randomization until first confirmed disease progression, disease then assessed per local practice until 2nd progression. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).
What was measured
Time from randomization to second progression or death (PFS2) was defined as the time from the date of randomization to the earliest of the progression event subsequent to first subsequent therapy or death (ie, date of PFS2 event or censoring - date of randomization +1). Median PFS2 was calculated using the Kaplan-Meier technique.
Analysis population: The PD-L1-Low/Negative analysis set will include the subset of patients in the FAS whose PD-L1 status is PD-L1-Low/negative as defined by an Immunohistochemistry (IHC) assay developed by Ventana as: \<25% tumor cell membrane positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control AND \<25% tumor associated immune cell positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control.
Groups in this outcome
Combination Therapy
MEDI4736 (Durvalumab) + Tremelimumab
Monotherapy
MEDI4736 (Durvalumab)
Standard of Care
Standard of Care Chemotherapy Treatment
| Group | Source count |
|---|---|
| Combination Therapy | 137 |
| Monotherapy | 137 |
| Standard of Care | 137 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Combination Therapy | 10.7 | Not reported | 7.5 | 16.6 | Not reported |
| Monotherapy | 9.4 | Not reported | 7.0 | 13.7 | Not reported |
| Standard of Care | 11.6 | Not reported | 10.3 | 13.4 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.772
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.391
- estimate Comment
- The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.
- group Ids
- OG000
- OG002
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.8148
- p Value Comment
- The 2-sided p-value was calculated using a stratified log-rank test adjusting for visceral metastases and cisplatin eligibility status.
- param Type
- Hazard Ratio (HR)
- param Value
- 1.04
- statistical Method
- Log Rank
- ci Lower Limit
- 0.636
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.134
- estimate Comment
- The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.
- group Description
- monotherapy as reference.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.2684
- p Value Comment
- The 2-sided p-value was calculated using a stratified log-rank test adjusting for visceral metastases and cisplatin eligibility status.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.85
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.772
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.391
- estimate Comment
- The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.
- group Ids
- OG000
- OG002
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.8148
- p Value Comment
- The 2-sided p-value was calculated using a stratified log-rank test adjusting for visceral metastases and cisplatin eligibility status.
- param Type
- Hazard Ratio (HR)
- param Value
- 1.04
- statistical Method
- Log Rank
- ci Lower Limit
- 0.636
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.134
- estimate Comment
- The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.
- group Description
- monotherapy as reference.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.2684
- p Value Comment
- The 2-sided p-value was calculated using a stratified log-rank test adjusting for visceral metastases and cisplatin eligibility status.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.85
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 7.5
- upper Limit
- 16.6
- value
- 10.7
- group Id
- OG001
- lower Limit
- 7.0
- upper Limit
- 13.7
- value
- 9.4
- group Id
- OG002
- lower Limit
- 10.3
- upper Limit
- 13.4
- value
- 11.6
- denoms
- counts
- group Id
- OG000
- value
- 137
- group Id
- OG001
- value
- 137
- group Id
- OG002
- value
- 137
- units
- Participants
- description
- Time from randomization to second progression or death (PFS2) was defined as the time from the date of randomization to the earliest of the progression event subsequent to first subsequent therapy or death (ie, date of PFS2 event or censoring - date of randomization +1). Median PFS2 was calculated using the Kaplan-Meier technique.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- MEDI4736 (Durvalumab) + Tremelimumab
- id
- OG000
- title
- Combination Therapy
- description
- MEDI4736 (Durvalumab)
- id
- OG001
- title
- Monotherapy
- description
- Standard of Care Chemotherapy Treatment
- id
- OG002
- title
- Standard of Care
- param Type
- MEDIAN
- population Description
- The PD-L1-Low/Negative analysis set will include the subset of patients in the FAS whose PD-L1 status is PD-L1-Low/negative as defined by an Immunohistochemistry (IHC) assay developed by Ventana as: \<25% tumor cell membrane positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control AND \<25% tumor associated immune cell positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control.
- reporting Status
- POSTED
- time Frame
- Tumour scans performed at baseline then every 8 weeks since randomization until first confirmed disease progression, disease then assessed per local practice until 2nd progression. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).
- title
- PFS2, PD-L1-Low/Negative Analysis Set -Durvalumab + Tremelimumab Combination Therapy Versus SoC and Durvalumab + Tremelimumab Combination Therapy Versus Durvalumab Monotherapy
- type
- SECONDARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice