TriangleNCT02414139 · OUTCOME
Overall Response Rate (ORR) by Blinded Independent Review Committee (BIRC) Assessment
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
- 95% Confidence Interval
- Time frame
- Up to approximately 5 years
What was measured
Percentage of participants with a best overall response defined as confirmed complete response (CR) or partial response (PR) by BIRC assessment per RECIST 1.1. CR: Disappearance of all non-nodal target and non-target lesions. In addition, any pathological lymph nodes assigned as target and non-target lesions must have a reduction in short axis to \< 10 mm PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
Analysis population: Full Analysis Set (FAS)-including all subjects who received at least one dose of capmatinib
Groups in this outcome
Cohort 1a: Pre-treated Patients With MET GCN ≥ 10 (2/3L)
Pre-treated patients with MET GCN ≥ 10 treated with INC280 at 400mg BID as second or third line (2/3L)
Cohort 1b: Pre-treated Patients With MET GCN ≥ 6 and < 10 (2/3L)
Pre-treated patients with MET GCN ≥ 6 and \< 10 treated with INC280 at 400 mg BID as second or third line (2/3L)
Cohort 2: Pre-treated Patients With MET GCN ≥ 4 and < 6 (2/3L)
Pre-treated patients with MET GCN ≥ 4 and \< 6 treated with INC280 at 400mg BID as second or third line (2/3L)
Cohort 3: Pre-treated Patients With MET GCN < 4 (2/3L)
Pre-treated patients with MET GCN \< 4 treated with INC280 at 400mg BID as second or third line (2/3L)
Cohort 4: Pre-treated Patients With MET Mutation Regardless of MET GCN (2/3L)
Pre-treated patients with MET mutation regardless of MET GCN treated with INC280 at 400mg BID as second or third line (2/3L)
Cohort 5a: Treatment-naïve Patients With MET GCN ≥10 (1L)
Treatment-naïve patients with MET GCN ≥10 treated with INC280 at 400mg BID as first-line (1L)
Cohort 5b: Treatment-naïve Patients With MET Mutation Regardless of MET GCN (1L)
Treatment-naïve patients with MET mutation regardless of MET GCN treated with INC280 at 400mg BID as first line (1L)
Cohort 6.1 (Expansion of Cohort 1a): Pre-treated Patients MET GCN ≥ 10 Without MET Mutation (2L)
Pre-treated patients with MET GCN ≥ 10 without MET mutation treated with INC280 at 400 mg BID as second line (2L) (expansion cohort of Cohort 1a)
Cohort 6.2 (Expansion of Cohort 4): Pre-treated Patients With MET Mutation (2L)
Pre-treated patients with MET mutation regardless of MET GCN treated with INC280 at 400 mg BID as second line (2L)(expansion of Cohort 4)
Cohort 7 (Expansion of Cohort 5b): Treatment-naïve With MET Mutation Regardless of MET GCN (1L)
Treatment-naïve patients with MET mutation regardless of MET GCN treated with INC280 at 400mg BID as first line (1L) (expansion cohort of Cohort 5b)
Cohort 4 + Cohort 6.2: All Pre-treated Patients With MET Mutation Regardless of MET GCN (2/3L)
All pre-treated patients with MET mutation regardless of MET GCN treated with INC280 at 400mg BID as second or third line (2/3L). (Participants from Cohort 4 and Cohort 6.2)
Cohort 5b + Cohort 7: All Treatment-naive With MET Mutation Regardless of MET GCN (1L)
All treatment naive patients with MET mutation regardless of MET GCN treated with INC280 at 400 mg BID as first line (1L) (Participants from Cohort 5b and Cohort 7)
| Group | Source count |
|---|---|
| Cohort 1a: Pre-treated Patients With MET GCN ≥ 10 (2/3L) | 69 |
| Cohort 1b: Pre-treated Patients With MET GCN ≥ 6 and < 10 (2/3L) | 42 |
| Cohort 2: Pre-treated Patients With MET GCN ≥ 4 and < 6 (2/3L) | 54 |
| Cohort 3: Pre-treated Patients With MET GCN < 4 (2/3L) | 30 |
| Cohort 4: Pre-treated Patients With MET Mutation Regardless of MET GCN (2/3L) | 69 |
| Cohort 5a: Treatment-naïve Patients With MET GCN ≥10 (1L) | 15 |
| Cohort 5b: Treatment-naïve Patients With MET Mutation Regardless of MET GCN (1L) | 28 |
| Cohort 6.1 (Expansion of Cohort 1a): Pre-treated Patients MET GCN ≥ 10 Without MET Mutation (2L) | 3 |
| Cohort 6.2 (Expansion of Cohort 4): Pre-treated Patients With MET Mutation (2L) | 31 |
| Cohort 7 (Expansion of Cohort 5b): Treatment-naïve With MET Mutation Regardless of MET GCN (1L) | 32 |
| Cohort 4 + Cohort 6.2: All Pre-treated Patients With MET Mutation Regardless of MET GCN (2/3L) | 100 |
| Cohort 5b + Cohort 7: All Treatment-naive With MET Mutation Regardless of MET GCN (1L) | 60 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1a: Pre-treated Patients With MET GCN ≥ 10 (2/3L) | 29.0 | Not reported | 18.7 | 41.2 | Not reported |
| Cohort 1b: Pre-treated Patients With MET GCN ≥ 6 and < 10 (2/3L) | 11.9 | Not reported | 4.0 | 25.6 | Not reported |
| Cohort 2: Pre-treated Patients With MET GCN ≥ 4 and < 6 (2/3L) | 9.3 | Not reported | 3.1 | 20.3 | Not reported |
| Cohort 3: Pre-treated Patients With MET GCN < 4 (2/3L) | 6.7 | Not reported | 0.8 | 22.1 | Not reported |
| Cohort 4: Pre-treated Patients With MET Mutation Regardless of MET GCN (2/3L) | 40.6 | Not reported | 28.9 | 53.1 | Not reported |
| Cohort 5a: Treatment-naïve Patients With MET GCN ≥10 (1L) | 40.0 | Not reported | 16.3 | 67.7 | Not reported |
| Cohort 5b: Treatment-naïve Patients With MET Mutation Regardless of MET GCN (1L) | 67.9 | Not reported | 47.6 | 84.1 | Not reported |
| Cohort 6.1 (Expansion of Cohort 1a): Pre-treated Patients MET GCN ≥ 10 Without MET Mutation (2L) | 0.0 | Not reported | 0.0 | 70.8 | Not reported |
| Cohort 6.2 (Expansion of Cohort 4): Pre-treated Patients With MET Mutation (2L) | 51.6 | Not reported | 33.1 | 69.8 | Not reported |
| Cohort 7 (Expansion of Cohort 5b): Treatment-naïve With MET Mutation Regardless of MET GCN (1L) | 68.8 | Not reported | 50.0 | 83.9 | Not reported |
| Cohort 4 + Cohort 6.2: All Pre-treated Patients With MET Mutation Regardless of MET GCN (2/3L) | 44.0 | Not reported | 34.1 | 54.3 | Not reported |
| Cohort 5b + Cohort 7: All Treatment-naive With MET Mutation Regardless of MET GCN (1L) | 68.3 | Not reported | 55.0 | 79.7 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 18.7
- upper Limit
- 41.2
- value
- 29.0
- group Id
- OG001
- lower Limit
- 4.0
- upper Limit
- 25.6
- value
- 11.9
- group Id
- OG002
- lower Limit
- 3.1
- upper Limit
- 20.3
- value
- 9.3
- group Id
- OG003
- lower Limit
- 0.8
- upper Limit
- 22.1
- value
- 6.7
- group Id
- OG004
- lower Limit
- 28.9
- upper Limit
- 53.1
- value
- 40.6
- group Id
- OG005
- lower Limit
- 16.3
- upper Limit
- 67.7
- value
- 40.0
- group Id
- OG006
- lower Limit
- 47.6
- upper Limit
- 84.1
- value
- 67.9
- group Id
- OG007
- lower Limit
- 0.0
- upper Limit
- 70.8
- value
- 0.0
- group Id
- OG008
- lower Limit
- 33.1
- upper Limit
- 69.8
- value
- 51.6
- group Id
- OG009
- lower Limit
- 50.0
- upper Limit
- 83.9
- value
- 68.8
- group Id
- OG010
- lower Limit
- 34.1
- upper Limit
- 54.3
- value
- 44.0
- group Id
- OG011
- lower Limit
- 55.0
- upper Limit
- 79.7
- value
- 68.3
- denoms
- counts
- group Id
- OG000
- value
- 69
- group Id
- OG001
- value
- 42
- group Id
- OG002
- value
- 54
- group Id
- OG003
- value
- 30
- group Id
- OG004
- value
- 69
- group Id
- OG005
- value
- 15
- group Id
- OG006
- value
- 28
- group Id
- OG007
- value
- 3
- group Id
- OG008
- value
- 31
- group Id
- OG009
- value
- 32
- group Id
- OG010
- value
- 100
- group Id
- OG011
- value
- 60
- units
- Participants
- description
- Percentage of participants with a best overall response defined as confirmed complete response (CR) or partial response (PR) by BIRC assessment per RECIST 1.1. CR: Disappearance of all non-nodal target and non-target lesions. In addition, any pathological lymph nodes assigned as target and non-target lesions must have a reduction in short axis to \< 10 mm PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Pre-treated patients with MET GCN ≥ 10 treated with INC280 at 400mg BID as second or third line (2/3L)
- id
- OG000
- title
- Cohort 1a: Pre-treated Patients With MET GCN ≥ 10 (2/3L)
- description
- Pre-treated patients with MET GCN ≥ 6 and \< 10 treated with INC280 at 400 mg BID as second or third line (2/3L)
- id
- OG001
- title
- Cohort 1b: Pre-treated Patients With MET GCN ≥ 6 and < 10 (2/3L)
- description
- Pre-treated patients with MET GCN ≥ 4 and \< 6 treated with INC280 at 400mg BID as second or third line (2/3L)
- id
- OG002
- title
- Cohort 2: Pre-treated Patients With MET GCN ≥ 4 and < 6 (2/3L)
- description
- Pre-treated patients with MET GCN \< 4 treated with INC280 at 400mg BID as second or third line (2/3L)
- id
- OG003
- title
- Cohort 3: Pre-treated Patients With MET GCN < 4 (2/3L)
- description
- Pre-treated patients with MET mutation regardless of MET GCN treated with INC280 at 400mg BID as second or third line (2/3L)
- id
- OG004
- title
- Cohort 4: Pre-treated Patients With MET Mutation Regardless of MET GCN (2/3L)
- description
- Treatment-naïve patients with MET GCN ≥10 treated with INC280 at 400mg BID as first-line (1L)
- id
- OG005
- title
- Cohort 5a: Treatment-naïve Patients With MET GCN ≥10 (1L)
- description
- Treatment-naïve patients with MET mutation regardless of MET GCN treated with INC280 at 400mg BID as first line (1L)
- id
- OG006
- title
- Cohort 5b: Treatment-naïve Patients With MET Mutation Regardless of MET GCN (1L)
- description
- Pre-treated patients with MET GCN ≥ 10 without MET mutation treated with INC280 at 400 mg BID as second line (2L) (expansion cohort of Cohort 1a)
- id
- OG007
- title
- Cohort 6.1 (Expansion of Cohort 1a): Pre-treated Patients MET GCN ≥ 10 Without MET Mutation (2L)
- description
- Pre-treated patients with MET mutation regardless of MET GCN treated with INC280 at 400 mg BID as second line (2L)(expansion of Cohort 4)
- id
- OG008
- title
- Cohort 6.2 (Expansion of Cohort 4): Pre-treated Patients With MET Mutation (2L)
- description
- Treatment-naïve patients with MET mutation regardless of MET GCN treated with INC280 at 400mg BID as first line (1L) (expansion cohort of Cohort 5b)
- id
- OG009
- title
- Cohort 7 (Expansion of Cohort 5b): Treatment-naïve With MET Mutation Regardless of MET GCN (1L)
- description
- All pre-treated patients with MET mutation regardless of MET GCN treated with INC280 at 400mg BID as second or third line (2/3L). (Participants from Cohort 4 and Cohort 6.2)
- id
- OG010
- title
- Cohort 4 + Cohort 6.2: All Pre-treated Patients With MET Mutation Regardless of MET GCN (2/3L)
- description
- All treatment naive patients with MET mutation regardless of MET GCN treated with INC280 at 400 mg BID as first line (1L) (Participants from Cohort 5b and Cohort 7)
- id
- OG011
- title
- Cohort 5b + Cohort 7: All Treatment-naive With MET Mutation Regardless of MET GCN (1L)
- param Type
- NUMBER
- population Description
- Full Analysis Set (FAS)-including all subjects who received at least one dose of capmatinib
- reporting Status
- POSTED
- time Frame
- Up to approximately 5 years
- title
- Overall Response Rate (ORR) by Blinded Independent Review Committee (BIRC) Assessment
- type
- PRIMARY
- unit Of Measure
- Percentage of Participants
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Preserved source evidence · Not medical advice