NCT02460224 · OUTCOME
Phase 2: Overall Response Rate (ORR) Per irRC
Safety and Efficacy of LAG525 Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies. · Source last updated 2022-02-10
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
- From start of treatment until end of treatment, assessed up to 2.6 years
What was measured
Tumor response was based on local investigator assessment and the assessment criteria was immune-related Response Criteria (irRC). ORR per irRC is defined as the percentage of participants with a best overall response of immune related Complete Response (irCR) or immune related Partial Response (irPR).
For irRC, irCR=Disappearance of all non-nodal target lesions and non-target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; irPR= At least a 30% decrease in the sum of diameters of all target lesions including new target lesions, taking as reference the baseline sum of diameters.
ORR is reported by tumor type.
Analysis population: All patients in phase 2 who received at least one full or partial dose of LAG525 or PDR001.
Groups in this outcome
Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients naïve to anti-PD-1/PD-L1
Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W
Combination LAG525 600 mg + PDR001 400 mg (Q4W/Q4W) in patients naïve to anti-PD-1/PD-L1
Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients pre-treated with anti-PD-1/PD-L1
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 121 |
|---|
| Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W | 21 |
|---|
| Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 93 |
|---|
Reported measurements
Non-small cell lung cancer (NSCLC)
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 20 |
|---|
| Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W | 0 |
|---|
| Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 22 |
|---|
Values in percentage of participants · Interval/dispersion: 90% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 15.0 | Not reported | 4.2 | 34.4 | Not reported |
|---|
| Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 0 | Not reported | 0.0 | 12.7 | Not reported |
|---|
Melanoma
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 20 |
|---|
| Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W | 0 |
|---|
| Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 22 |
|---|
Values in percentage of participants · Interval/dispersion: 90% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 15.0 | Not reported | 4.2 | 34.4 | Not reported |
|---|
| Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 9.1 | Not reported | 1.6 | 25.9 | Not reported |
|---|
Renal cell cancer (RCC)
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 19 |
|---|
| Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W | 0 |
|---|
| Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 19 |
|---|
Values in percentage of participants · Interval/dispersion: 90% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 26.3 | Not reported | 11.0 | 47.6 | Not reported |
|---|
| Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 5.3 | Not reported | 0.3 | 22.6 | Not reported |
|---|
Mesothelioma
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 41 |
|---|
| Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W | 0 |
|---|
| Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 16 |
|---|
Values in percentage of participants · Interval/dispersion: 90% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 19.5 | Not reported | 10.1 | 32.5 | Not reported |
|---|
| Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 6.3 | Not reported | 0.3 | 26.4 | Not reported |
|---|
Triple negative breast cancer (TNBC)
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 21 |
|---|
| Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W | 21 |
|---|
| Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 14 |
|---|
Values in percentage of participants · Interval/dispersion: 90% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 14.3 | Not reported | 4.0 | 32.9 | Not reported |
|---|
| Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W | 4.8 | Not reported | 0.2 | 20.7 | Not reported |
|---|
| Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 0 | Not reported | 0.0 | 19.3 | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 4.2
- upper Limit
- 34.4
- value
- 15.0
- group Id
- OG002
- lower Limit
- 0.0
- upper Limit
- 12.7
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 20
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 22
- units
- Participants
- title
- Non-small cell lung cancer (NSCLC)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 4.2
- upper Limit
- 34.4
- value
- 15.0
- group Id
- OG002
- lower Limit
- 1.6
- upper Limit
- 25.9
- value
- 9.1
- denoms
- counts
- group Id
- OG000
- value
- 20
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 22
- units
- Participants
- title
- Melanoma
- categories
- measurements
- group Id
- OG000
- lower Limit
- 11.0
- upper Limit
- 47.6
- value
- 26.3
- group Id
- OG002
- lower Limit
- 0.3
- upper Limit
- 22.6
- value
- 5.3
- denoms
- counts
- group Id
- OG000
- value
- 19
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 19
- units
- Participants
- title
- Renal cell cancer (RCC)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 10.1
- upper Limit
- 32.5
- value
- 19.5
- group Id
- OG002
- lower Limit
- 0.3
- upper Limit
- 26.4
- value
- 6.3
- denoms
- counts
- group Id
- OG000
- value
- 41
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 16
- units
- Participants
- title
- Mesothelioma
- categories
- measurements
- group Id
- OG000
- lower Limit
- 4.0
- upper Limit
- 32.9
- value
- 14.3
- group Id
- OG001
- lower Limit
- 0.2
- upper Limit
- 20.7
- value
- 4.8
- group Id
- OG002
- lower Limit
- 0.0
- upper Limit
- 19.3
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 21
- group Id
- OG001
- value
- 21
- group Id
- OG002
- value
- 14
- units
- Participants
- title
- Triple negative breast cancer (TNBC)
- denoms
- counts
- group Id
- OG000
- value
- 121
- group Id
- OG001
- value
- 21
- group Id
- OG002
- value
- 93
- units
- Participants
- description
- Tumor response was based on local investigator assessment and the assessment criteria was immune-related Response Criteria (irRC). ORR per irRC is defined as the percentage of participants with a best overall response of immune related Complete Response (irCR) or immune related Partial Response (irPR).
For irRC, irCR=Disappearance of all non-nodal target lesions and non-target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; irPR= At least a 30% decrease in the sum of diameters of all target lesions including new target lesions, taking as reference the baseline sum of diameters.
ORR is reported by tumor type.
- dispersion Type
- 90% Confidence Interval
- groups
- description
- Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients naïve to anti-PD-1/PD-L1
- id
- OG000
- title
- Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W
- description
- Combination LAG525 600 mg + PDR001 400 mg (Q4W/Q4W) in patients naïve to anti-PD-1/PD-L1
- id
- OG001
- title
- Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W
- description
- Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients pre-treated with anti-PD-1/PD-L1
- id
- OG002
- title
- Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W
- param Type
- NUMBER
- population Description
- All patients in phase 2 who received at least one full or partial dose of LAG525 or PDR001.
- reporting Status
- POSTED
- time Frame
- From start of treatment until end of treatment, assessed up to 2.6 years
- title
- Phase 2: Overall Response Rate (ORR) Per irRC
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
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