TriangleNCT04680052 · OUTCOME
Overall Population: Kaplan-Meier Estimates of DOR (the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by IRC Review
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percent probability
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- up to 2 years
What was measured
PET, CR: (1) score of 1 (no uptake above background), 2 (uptake ≤ mediastinum), or 3 (uptake \> mediastinum but ≤ liver) with/without a residual mass for lymph nodes and extralymphatic sites (LN/ELS); (2) no evidence of FDG-avid disease in bone marrow; (3) no new lesions. PR: (1) score of 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) with reduced uptake compared with Baseline and residual mass(es) of any size for LN/ELS; (2) residual uptake higher than in normal bone marrow but reduced from Baseline; (3) no new lesions. CT, CR: (1) target nodes/nodal masses regressed to ≤1.5 cm in LDi. no extra lymphatic site of disease; (2) absent nontarget lesions; (3) liver/spleen regressed to normal; (4) bone marrow normal by morphology; (5) no new lesions. PR: (1) ≥50% decrease in SPD of up to 6 target measurable nodes and extranodal sites; (2) no increase in target lesions; (3) spleen regressed by \>50% in length beyond normal; (4) no new lesions.
Analysis population: Overall Full Analysis Set. Per the SAP, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population (main analysis population). Participants who achieved CR or PR were analyzed. The number of participants analyzed for the Kaplan-Meier estimate at each time point refers to the total number of participants in the analysis set.
Groups in this outcome
FL and MZL: Tafasitamab + Rituximab + Lenalidomide
Participants with FL and MZL were randomized to receive tafasitamab 12 mg/kg IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
FL and MZL: Placebo + Rituximab + Lenalidomide
Participants with FL and MZL were randomized to receive placebo 0.9% saline solution IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
| Group | Source count |
|---|---|
| FL and MZL: Tafasitamab + Rituximab + Lenalidomide | 273 |
| FL and MZL: Placebo + Rituximab + Lenalidomide | 238 |
Reported measurements
6 months
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| FL and MZL: Tafasitamab + Rituximab + Lenalidomide | 93.1 | Not reported | 88.9 | 95.7 | Not reported |
| FL and MZL: Placebo + Rituximab + Lenalidomide | 81.5 | Not reported | 75.5 | 86.2 | Not reported |
12 months
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| FL and MZL: Tafasitamab + Rituximab + Lenalidomide | 80.0 | Not reported | 73.0 | 85.3 | Not reported |
| FL and MZL: Placebo + Rituximab + Lenalidomide | 65.6 | Not reported | 57.6 | 72.5 | Not reported |
18 months
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| FL and MZL: Tafasitamab + Rituximab + Lenalidomide | 65.7 | Not reported | 55.8 | 73.8 | Not reported |
| FL and MZL: Placebo + Rituximab + Lenalidomide | 56.5 | Not reported | 46.9 | 65.0 | Not reported |
2 years
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| FL and MZL: Tafasitamab + Rituximab + Lenalidomide | 56.0 | Not reported | 41.5 | 68.2 | Not reported |
| FL and MZL: Placebo + Rituximab + Lenalidomide | 40.9 | Not reported | 27.8 | 53.6 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.409
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 3.475
- estimate Comment
- The hazard ratio was estimated using a stratified Cox proportional hazards model.
- group Ids
- OG000
- OG001
- non Inferiority Comment
- Only primary and key secondary endpoints were formally tested; this endpoint was not formally tested.
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.7469
- param Type
- Hazard Ratio (HR)
- param Value
- 1.192
- statistical Method
- stratified Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.409
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 3.475
- estimate Comment
- The hazard ratio was estimated using a stratified Cox proportional hazards model.
- group Ids
- OG000
- OG001
- non Inferiority Comment
- Only primary and key secondary endpoints were formally tested; this endpoint was not formally tested.
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.7469
- param Type
- Hazard Ratio (HR)
- param Value
- 1.192
- statistical Method
- stratified Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 88.9
- upper Limit
- 95.7
- value
- 93.1
- group Id
- OG001
- lower Limit
- 75.5
- upper Limit
- 86.2
- value
- 81.5
- title
- 6 months
- categories
- measurements
- group Id
- OG000
- lower Limit
- 73.0
- upper Limit
- 85.3
- value
- 80.0
- group Id
- OG001
- lower Limit
- 57.6
- upper Limit
- 72.5
- value
- 65.6
- title
- 12 months
- categories
- measurements
- group Id
- OG000
- lower Limit
- 55.8
- upper Limit
- 73.8
- value
- 65.7
- group Id
- OG001
- lower Limit
- 46.9
- upper Limit
- 65.0
- value
- 56.5
- title
- 18 months
- categories
- measurements
- group Id
- OG000
- lower Limit
- 41.5
- upper Limit
- 68.2
- value
- 56.0
- group Id
- OG001
- lower Limit
- 27.8
- upper Limit
- 53.6
- value
- 40.9
- title
- 2 years
- denoms
- counts
- group Id
- OG000
- value
- 273
- group Id
- OG001
- value
- 238
- units
- Participants
- description
- PET, CR: (1) score of 1 (no uptake above background), 2 (uptake ≤ mediastinum), or 3 (uptake \> mediastinum but ≤ liver) with/without a residual mass for lymph nodes and extralymphatic sites (LN/ELS); (2) no evidence of FDG-avid disease in bone marrow; (3) no new lesions. PR: (1) score of 4 (uptake moderately \> liver) or 5 (uptake markedly higher than liver and/or new lesions) with reduced uptake compared with Baseline and residual mass(es) of any size for LN/ELS; (2) residual uptake higher than in normal bone marrow but reduced from Baseline; (3) no new lesions. CT, CR: (1) target nodes/nodal masses regressed to ≤1.5 cm in LDi. no extra lymphatic site of disease; (2) absent nontarget lesions; (3) liver/spleen regressed to normal; (4) bone marrow normal by morphology; (5) no new lesions. PR: (1) ≥50% decrease in SPD of up to 6 target measurable nodes and extranodal sites; (2) no increase in target lesions; (3) spleen regressed by \>50% in length beyond normal; (4) no new lesions.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with FL and MZL were randomized to receive tafasitamab 12 mg/kg IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
- id
- OG000
- title
- FL and MZL: Tafasitamab + Rituximab + Lenalidomide
- description
- Participants with FL and MZL were randomized to receive placebo 0.9% saline solution IV, administered on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 of Cycles 4 to 12. Participants also received oral lenalidomide (including generics) 20 mg QD, administered at approximately the same time every day on Days 1 to 21 of Cycles 1 to 12, and rituximab (including biosimilars) 375 mg/m\^2 IV, administered on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. A treatment cycle was defined as 28 calendar days.
- id
- OG001
- title
- FL and MZL: Placebo + Rituximab + Lenalidomide
- param Type
- NUMBER
- population Description
- Overall Full Analysis Set. Per the SAP, the MZL population was considered as a subpopulation of interest, not a main analysis population. The FL and MZL populations were combined for analysis into the Overall population (main analysis population). Participants who achieved CR or PR were analyzed. The number of participants analyzed for the Kaplan-Meier estimate at each time point refers to the total number of participants in the analysis set.
- reporting Status
- POSTED
- time Frame
- up to 2 years
- title
- Overall Population: Kaplan-Meier Estimates of DOR (the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by IRC Review
- type
- SECONDARY
- unit Of Measure
- percent probability
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Preserved source evidence · Not medical advice