TriangleNCT01953692 · OUTCOME
Objective Response Rate (ORR) in the Cohort 4 Non-Hodgkin Lymphoma (NHL) Individual Sub-Cohorts (Cohorts 4A, 4B, 4C, and 4D)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of participants
- Interval / dispersion
- 90% Confidence Interval
- Time frame
- Up to approximately 78.5 months
What was measured
ORR was evaluated for each of the Cohort 4 sub-cohorts: 4A (primary mediastinal B-cell lymphoma), 4B (grey zone, splenic marginal zone, and mantle cell lymphomas), 4C (follicular lymphoma), and 4D (diffuse large B-Cell lymphoma). ORR was defined as the percentage of participants with response (complete response \[CR\] or partial response \[PR\]) according to the revised response criteria for malignant lymphoma per Cheson et al. 2007. CR was demonstrated by disappearance of all evidence of disease in the bone marrow, spleen, liver, and lymph nodes. PR was \>50% decrease in the sum of product diameters (SPD) for ≤6 target masses for lymph nodes and \>50% decrease in SPD for a single nodule in greatest transverse diameter for spleen and liver, and no size increase in the lymph nodes, spleen, or liver. Per protocol, Cohorts 4A, 4B, 4C, and 4D were not planned to be compared to an efficacy target. The percentage of participants with CR and PR as assessed by the investigator is presented.
Analysis population: All participants in Cohorts 4A, 4B, 4C, and 4D with a baseline efficacy evaluation and at least 1 post-baseline efficacy evaluation. The analysis was pre-specified to be a pooled analysis of participants grouped by disease cohort (NHL).
Groups in this outcome
Cohort 4A: R/R Primary Mediastinal B-cell Lymphoma (PMBCL)
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle OR 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.
Cohort 4B: Other Non-Hodgkin Lymphoma: Grey Zone, Splenic Marginal Zone, and Mantle Cell Lymphomas
Participants received pembrolizumab 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.
Cohort 4C: R/R Follicular Lymphoma (FL)
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle.
Cohort 4D: R/R Diffuse Large B-Cell Lymphoma (DLBCL)
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle.
| Group | Source count |
|---|---|
| Cohort 4A: R/R Primary Mediastinal B-cell Lymphoma (PMBCL) | 21 |
| Cohort 4B: Other Non-Hodgkin Lymphoma: Grey Zone, Splenic Marginal Zone, and Mantle Cell Lymphomas | 4 |
| Cohort 4C: R/R Follicular Lymphoma (FL) | 20 |
| Cohort 4D: R/R Diffuse Large B-Cell Lymphoma (DLBCL) | 41 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 4A: R/R Primary Mediastinal B-cell Lymphoma (PMBCL) | 47.6 | Not reported | 28.6 | 67.2 | Not reported |
| Cohort 4B: Other Non-Hodgkin Lymphoma: Grey Zone, Splenic Marginal Zone, and Mantle Cell Lymphomas | 50.0 | Not reported | 9.8 | 90.2 | Not reported |
| Cohort 4C: R/R Follicular Lymphoma (FL) | 10.0 | Not reported | 1.8 | 28.3 | Not reported |
| Cohort 4D: R/R Diffuse Large B-Cell Lymphoma (DLBCL) | 12.2 | Not reported | 4.9 | 23.9 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 28.6
- upper Limit
- 67.2
- value
- 47.6
- group Id
- OG001
- lower Limit
- 9.8
- upper Limit
- 90.2
- value
- 50.0
- group Id
- OG002
- lower Limit
- 1.8
- upper Limit
- 28.3
- value
- 10.0
- group Id
- OG003
- lower Limit
- 4.9
- upper Limit
- 23.9
- value
- 12.2
- denoms
- counts
- group Id
- OG000
- value
- 21
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 20
- group Id
- OG003
- value
- 41
- units
- Participants
- description
- ORR was evaluated for each of the Cohort 4 sub-cohorts: 4A (primary mediastinal B-cell lymphoma), 4B (grey zone, splenic marginal zone, and mantle cell lymphomas), 4C (follicular lymphoma), and 4D (diffuse large B-Cell lymphoma). ORR was defined as the percentage of participants with response (complete response \[CR\] or partial response \[PR\]) according to the revised response criteria for malignant lymphoma per Cheson et al. 2007. CR was demonstrated by disappearance of all evidence of disease in the bone marrow, spleen, liver, and lymph nodes. PR was \>50% decrease in the sum of product diameters (SPD) for ≤6 target masses for lymph nodes and \>50% decrease in SPD for a single nodule in greatest transverse diameter for spleen and liver, and no size increase in the lymph nodes, spleen, or liver. Per protocol, Cohorts 4A, 4B, 4C, and 4D were not planned to be compared to an efficacy target. The percentage of participants with CR and PR as assessed by the investigator is presented.
- dispersion Type
- 90% Confidence Interval
- groups
- description
- Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle OR 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.
- id
- OG000
- title
- Cohort 4A: R/R Primary Mediastinal B-cell Lymphoma (PMBCL)
- description
- Participants received pembrolizumab 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.
- id
- OG001
- title
- Cohort 4B: Other Non-Hodgkin Lymphoma: Grey Zone, Splenic Marginal Zone, and Mantle Cell Lymphomas
- description
- Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle.
- id
- OG002
- title
- Cohort 4C: R/R Follicular Lymphoma (FL)
- description
- Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle.
- id
- OG003
- title
- Cohort 4D: R/R Diffuse Large B-Cell Lymphoma (DLBCL)
- param Type
- NUMBER
- population Description
- All participants in Cohorts 4A, 4B, 4C, and 4D with a baseline efficacy evaluation and at least 1 post-baseline efficacy evaluation. The analysis was pre-specified to be a pooled analysis of participants grouped by disease cohort (NHL).
- reporting Status
- POSTED
- time Frame
- Up to approximately 78.5 months
- title
- Objective Response Rate (ORR) in the Cohort 4 Non-Hodgkin Lymphoma (NHL) Individual Sub-Cohorts (Cohorts 4A, 4B, 4C, and 4D)
- type
- PRIMARY
- unit Of Measure
- Percentage of participants
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Preserved source evidence · Not medical advice