NCT02460224 · OUTCOME
Phase 2: Duration of Response (DOR) 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
- MEDIAN
- Unit
- months
- Interval / dispersion
- 90% Confidence Interval
- Time frame
- From first documented response (irCR or irPR) to first documented progression or death due to study indication, assessed up to 2.6 years
What was measured
DOR only applies to subjects for whom best overall response is immune related complete response (irCR) or immune related partial response (irPR). DOR is defined as the time from the date of first documented response (irCR or irPR) to the date of first documented progression or death due to study indication. If a patient not had an event, duration was censored at the date of last adequate tumor assessment.
Tumor response was based on local investigator assessment and the assessment criteria was irRC.
DOR 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 and had a documented response (irCR or irPR).
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 | 22 |
|---|
| Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W | 1 |
|---|
| Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 4 |
|---|
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 | 3 |
|---|
| Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W | 0 |
|---|
| Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 0 |
|---|
Values in months · Interval/dispersion: 90% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W | NA | Not reported | NA | NA | Not estimable due to insufficient number of participants with events. |
|---|
Melanoma
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 3 |
|---|
| Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W | 0 |
|---|
| Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 2 |
|---|
Values in months · Interval/dispersion: 90% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 17.5 | Not reported | 11.0 | NA | Not estimable due to insufficient number of participants with events. |
|---|
| Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W | NA | Not reported | 18.2 | NA | Not estimable due to insufficient number of participants with events. |
|---|
Renal cell cancer (RCC)
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 5 |
|---|
| Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W | 0 |
|---|
| Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 1 |
|---|
Values in months · Interval/dispersion: 90% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W | NA | Not reported | 7.6 | NA | Not estimable due to insufficient number of participants with events. |
|---|
| Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W | NA | Not reported | NA | NA | Not estimable due to insufficient number of participants with events. |
|---|
Mesothelioma
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 8 |
|---|
| Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W | 0 |
|---|
| Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 1 |
|---|
Values in months · Interval/dispersion: 90% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W | NA | Not reported | 5.8 | NA | Not estimable due to insufficient number of participants with events. |
|---|
| Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W | NA | Not reported | NA | NA | Not estimable due to insufficient number of participants with events. |
|---|
Triple negative breast cancer (TNBC)
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 3 |
|---|
| Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W | 1 |
|---|
| Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W | 0 |
|---|
Values in months · Interval/dispersion: 90% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W | NA | Not reported | 7.6 | NA | Not estimable due to insufficient number of participants with events. |
|---|
| Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W | NA | Not reported | NA | NA | Not estimable due to insufficient number of participants with events. |
|---|
Complete source fields
- classes
- categories
- measurements
- comment
- Not estimable due to insufficient number of participants with events.
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- units
- Participants
- title
- Non-small cell lung cancer (NSCLC)
- categories
- measurements
- comment
- Not estimable due to insufficient number of participants with events.
- group Id
- OG000
- lower Limit
- 11.0
- upper Limit
- NA
- value
- 17.5
- comment
- Not estimable due to insufficient number of participants with events.
- group Id
- OG002
- lower Limit
- 18.2
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 2
- units
- Participants
- title
- Melanoma
- categories
- measurements
- comment
- Not estimable due to insufficient number of participants with events.
- group Id
- OG000
- lower Limit
- 7.6
- upper Limit
- NA
- value
- NA
- comment
- Not estimable due to insufficient number of participants with events.
- group Id
- OG002
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- units
- Participants
- title
- Renal cell cancer (RCC)
- categories
- measurements
- comment
- Not estimable due to insufficient number of participants with events.
- group Id
- OG000
- lower Limit
- 5.8
- upper Limit
- NA
- value
- NA
- comment
- Not estimable due to insufficient number of participants with events.
- group Id
- OG002
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- units
- Participants
- title
- Mesothelioma
- categories
- measurements
- comment
- Not estimable due to insufficient number of participants with events.
- group Id
- OG000
- lower Limit
- 7.6
- upper Limit
- NA
- value
- NA
- comment
- Not estimable due to insufficient number of participants with events.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- units
- Participants
- title
- Triple negative breast cancer (TNBC)
- denoms
- counts
- group Id
- OG000
- value
- 22
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 4
- units
- Participants
- description
- DOR only applies to subjects for whom best overall response is immune related complete response (irCR) or immune related partial response (irPR). DOR is defined as the time from the date of first documented response (irCR or irPR) to the date of first documented progression or death due to study indication. If a patient not had an event, duration was censored at the date of last adequate tumor assessment.
Tumor response was based on local investigator assessment and the assessment criteria was irRC.
DOR 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
- MEDIAN
- population Description
- All patients in phase 2 who received at least one full or partial dose of LAG525 or PDR001 and had a documented response (irCR or irPR).
- reporting Status
- POSTED
- time Frame
- From first documented response (irCR or irPR) to first documented progression or death due to study indication, assessed up to 2.6 years
- title
- Phase 2: Duration of Response (DOR) Per irRC
- type
- SECONDARY
- unit Of Measure
- months
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