NCT02713529 · OUTCOME
Kaplan-Meier Estimates for Progression-Free Survival (PFS) as Per irRECIST at Month 6 and Month 12
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
- Day 1 up to Month 6 or Month 12
What was measured
Progression-free survival time was calculated as the number of days from the first administration of AMG 820 to date of progressive disease or death or censoring divided by (365.25/12). Data are reported as the percentage of participants who were alive and progression-free at Month 6 and Month 12.
Analysis population: Safety Analysis Set
Groups in this outcome
Part 1: AMG 820 + Pem 200 mg
Part 1 Cohorts 1 + 2 combined. Participants with advanced solid tumors were treated with 1400 mg or 1100 mg AMG 820 plus 200 mg pembrolizumab (Pem) every three weeks (Q3W) to determine safety. Participants could be treated up to 24 months if treatment was tolerable and clinical benefit was observed.
Part 2, Group 1: CRC MMR-proficient
Group 1 is comprised of participants with colorectal cancer (CRC) who are proficient in mismatch repair genes (MMR). AMG 820 was administered at the recommended dose of 1100 mg intravenously in combination with pembrolizumab 200 mg every 3 weeks (± 3 days). Each group in Part 2 was evaluated separately using a Simon 2-stage design. Treatment continued until confirmed disease progression per modified irRECIST, or intolerance of study treatment, or clinically significant deterioration of health status requiring discontinuation, whichever occurred first, or the subject withdrew consent.
Part 2, Group 2: Pancreatic Cancer
Group 2 is comprised of participants with advanced pancreatic cancer who are naïve to anti programmed-death 1 (PD-1), anti PD-ligand 1 (PD-L1), colony stimulating factor 1 (CSF-1) and colony stimulating factor 1 receptor (CSF-1R) therapies. AMG 820 was administered at the recommended dose of 1100 mg intravenously in combination with pembrolizumab 200 mg every 3 weeks (± 3 days). Each group in Part 2 was evaluated separately using a Simon 2-stage design. Treatment continued until confirmed disease progression per modified irRECIST, or intolerance of study treatment, or clinically significant deterioration of health status requiring discontinuation, whichever occurred first, or the subject withdrew consent.
Part 2, Group 3: NSCLC PD-L1 Low, Naïve
Group 3 is comprised of participants with non-small cell lung cancer (NSCLC) who have low (\< 50%) tumor PD-L1- expression and are naïve to anti-PD-1/PD-L1/CSF-1/CSF-1R agents. AMG 820 was administered at the recommended dose of 1100 mg intravenously in combination with pembrolizumab 200 mg every 3 weeks (± 3 days). Each group in Part 2 was evaluated separately using a Simon 2-stage design. Treatment continued until confirmed disease progression per modified irRECIST, or intolerance of study treatment, or clinically significant deterioration of health status requiring discontinuation, whichever occurred first, or the subject withdrew consent.
Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low
Group 4a is comprised of participants who did not respond to or who relapsed during monotherapy with anti-PD-1/PD-L1 agents and are anti-CSF-1/CSF-1R naïve. These participants have low PD-L1 tumor expression (\<50%). AMG 820 was administered at the recommended dose of 1100 mg intravenously in combination with pembrolizumab 200 mg every 3 weeks (± 3 days). Each group in Part 2 was evaluated separately using a Simon 2-stage design. Treatment continued until confirmed disease progression per modified irRECIST, or intolerance of study treatment, or clinically significant deterioration of health status requiring discontinuation, whichever occurred first, or the subject withdrew consent.
Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High
Group 4b is comprised of participants who did not respond to or who relapsed during monotherapy with anti-PD-1/PD-L1 agents and are anti-CSF-1/CSF-1R naïve. These participants have high PD-L1 tumor expression (\>=50%). AMG 820 was administered at the recommended dose of 1100 mg intravenously in combination with pembrolizumab 200 mg every 3 weeks (± 3 days). Each group in Part 2 was evaluated separately using a Simon 2-stage design. Treatment continued until confirmed disease progression per modified irRECIST, or intolerance of study treatment, or clinically significant deterioration of health status requiring discontinuation, whichever occurred first, or the subject withdrew consent.
| Group | Source count |
|---|---|
| Part 1: AMG 820 + Pem 200 mg | 15 |
| Part 2, Group 1: CRC MMR-proficient | 41 |
| Part 2, Group 2: Pancreatic Cancer | 31 |
| Part 2, Group 3: NSCLC PD-L1 Low, Naïve | 4 |
| Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low | 19 |
| Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High | 6 |
Reported measurements
Month 6
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: AMG 820 + Pem 200 mg | 10.476 | Not reported | 1.23 | 31.40 | Not reported |
| Part 2, Group 1: CRC MMR-proficient | 13.490 | Not reported | 5.99 | 24.04 | Not reported |
| Part 2, Group 2: Pancreatic Cancer | 0.000 | Not reported | 0.00 | 0.00 | Not reported |
| Part 2, Group 3: NSCLC PD-L1 Low, Naïve | 25.000 | Not reported | 2.08 | 60.89 | Not reported |
| Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low | 26.471 | Not reported | 10.67 | 45.41 | Not reported |
| Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High | 33.333 | Not reported | 7.37 | 62.95 | Not reported |
Month 12
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: AMG 820 + Pem 200 mg | 0.000 | Not reported | 0.00 | 0.00 | Not reported |
| Part 2, Group 1: CRC MMR-proficient | 5.396 | Not reported | 1.36 | 13.77 | Not reported |
| Part 2, Group 2: Pancreatic Cancer | 0.000 | Not reported | 0.00 | 0.00 | Not reported |
| Part 2, Group 3: NSCLC PD-L1 Low, Naïve | 0.000 | Not reported | 0.00 | 0.00 | Not reported |
| Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low | 6.618 | Not reported | 0.77 | 21.97 | Not reported |
| Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High | 33.333 | Not reported | 7.37 | 62.95 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.23
- upper Limit
- 31.40
- value
- 10.476
- group Id
- OG001
- lower Limit
- 5.99
- upper Limit
- 24.04
- value
- 13.490
- group Id
- OG002
- lower Limit
- 0.00
- upper Limit
- 0.00
- value
- 0.000
- group Id
- OG003
- lower Limit
- 2.08
- upper Limit
- 60.89
- value
- 25.000
- group Id
- OG004
- lower Limit
- 10.67
- upper Limit
- 45.41
- value
- 26.471
- group Id
- OG005
- lower Limit
- 7.37
- upper Limit
- 62.95
- value
- 33.333
- title
- Month 6
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.00
- upper Limit
- 0.00
- value
- 0.000
- group Id
- OG001
- lower Limit
- 1.36
- upper Limit
- 13.77
- value
- 5.396
- group Id
- OG002
- lower Limit
- 0.00
- upper Limit
- 0.00
- value
- 0.000
- group Id
- OG003
- lower Limit
- 0.00
- upper Limit
- 0.00
- value
- 0.000
- group Id
- OG004
- lower Limit
- 0.77
- upper Limit
- 21.97
- value
- 6.618
- group Id
- OG005
- lower Limit
- 7.37
- upper Limit
- 62.95
- value
- 33.333
- title
- Month 12
- denoms
- counts
- group Id
- OG000
- value
- 15
- group Id
- OG001
- value
- 41
- group Id
- OG002
- value
- 31
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 19
- group Id
- OG005
- value
- 6
- units
- Participants
- description
- Progression-free survival time was calculated as the number of days from the first administration of AMG 820 to date of progressive disease or death or censoring divided by (365.25/12). Data are reported as the percentage of participants who were alive and progression-free at Month 6 and Month 12.
- dispersion Type
- 90% Confidence Interval
- groups
- description
- Part 1 Cohorts 1 + 2 combined. Participants with advanced solid tumors were treated with 1400 mg or 1100 mg AMG 820 plus 200 mg pembrolizumab (Pem) every three weeks (Q3W) to determine safety. Participants could be treated up to 24 months if treatment was tolerable and clinical benefit was observed.
- id
- OG000
- title
- Part 1: AMG 820 + Pem 200 mg
- description
- Group 1 is comprised of participants with colorectal cancer (CRC) who are proficient in mismatch repair genes (MMR). AMG 820 was administered at the recommended dose of 1100 mg intravenously in combination with pembrolizumab 200 mg every 3 weeks (± 3 days). Each group in Part 2 was evaluated separately using a Simon 2-stage design. Treatment continued until confirmed disease progression per modified irRECIST, or intolerance of study treatment, or clinically significant deterioration of health status requiring discontinuation, whichever occurred first, or the subject withdrew consent.
- id
- OG001
- title
- Part 2, Group 1: CRC MMR-proficient
- description
- Group 2 is comprised of participants with advanced pancreatic cancer who are naïve to anti programmed-death 1 (PD-1), anti PD-ligand 1 (PD-L1), colony stimulating factor 1 (CSF-1) and colony stimulating factor 1 receptor (CSF-1R) therapies. AMG 820 was administered at the recommended dose of 1100 mg intravenously in combination with pembrolizumab 200 mg every 3 weeks (± 3 days). Each group in Part 2 was evaluated separately using a Simon 2-stage design. Treatment continued until confirmed disease progression per modified irRECIST, or intolerance of study treatment, or clinically significant deterioration of health status requiring discontinuation, whichever occurred first, or the subject withdrew consent.
- id
- OG002
- title
- Part 2, Group 2: Pancreatic Cancer
- description
- Group 3 is comprised of participants with non-small cell lung cancer (NSCLC) who have low (\< 50%) tumor PD-L1- expression and are naïve to anti-PD-1/PD-L1/CSF-1/CSF-1R agents. AMG 820 was administered at the recommended dose of 1100 mg intravenously in combination with pembrolizumab 200 mg every 3 weeks (± 3 days). Each group in Part 2 was evaluated separately using a Simon 2-stage design. Treatment continued until confirmed disease progression per modified irRECIST, or intolerance of study treatment, or clinically significant deterioration of health status requiring discontinuation, whichever occurred first, or the subject withdrew consent.
- id
- OG003
- title
- Part 2, Group 3: NSCLC PD-L1 Low, Naïve
- description
- Group 4a is comprised of participants who did not respond to or who relapsed during monotherapy with anti-PD-1/PD-L1 agents and are anti-CSF-1/CSF-1R naïve. These participants have low PD-L1 tumor expression (\<50%). AMG 820 was administered at the recommended dose of 1100 mg intravenously in combination with pembrolizumab 200 mg every 3 weeks (± 3 days). Each group in Part 2 was evaluated separately using a Simon 2-stage design. Treatment continued until confirmed disease progression per modified irRECIST, or intolerance of study treatment, or clinically significant deterioration of health status requiring discontinuation, whichever occurred first, or the subject withdrew consent.
- id
- OG004
- title
- Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low
- description
- Group 4b is comprised of participants who did not respond to or who relapsed during monotherapy with anti-PD-1/PD-L1 agents and are anti-CSF-1/CSF-1R naïve. These participants have high PD-L1 tumor expression (\>=50%). AMG 820 was administered at the recommended dose of 1100 mg intravenously in combination with pembrolizumab 200 mg every 3 weeks (± 3 days). Each group in Part 2 was evaluated separately using a Simon 2-stage design. Treatment continued until confirmed disease progression per modified irRECIST, or intolerance of study treatment, or clinically significant deterioration of health status requiring discontinuation, whichever occurred first, or the subject withdrew consent.
- id
- OG005
- title
- Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High
- param Type
- NUMBER
- population Description
- Safety Analysis Set
- reporting Status
- POSTED
- time Frame
- Day 1 up to Month 6 or Month 12
- title
- Kaplan-Meier Estimates for Progression-Free Survival (PFS) as Per irRECIST at Month 6 and Month 12
- type
- SECONDARY
- unit Of Measure
- percentage of participants
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