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NCT02713529 · OUTCOME

Kaplan-Meier Estimates for Progression-Free Survival (PFS) as Per irRECIST at Month 6 and Month 12

Safety and Efficacy Study of AMG 820 and Pembrolizumab Combination in Select Advanced Solid Tumor Cancer · Source last updated 2023-01-20

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 identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Part 1: AMG 820 + Pem 200 mg15
Part 2, Group 1: CRC MMR-proficient41
Part 2, Group 2: Pancreatic Cancer31
Part 2, Group 3: NSCLC PD-L1 Low, Naïve4
Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low19
Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High6

Reported measurements

Month 6
Values in percentage of participants · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Part 1: AMG 820 + Pem 200 mg10.476Not reported1.2331.40Not reported
Part 2, Group 1: CRC MMR-proficient13.490Not reported5.9924.04Not reported
Part 2, Group 2: Pancreatic Cancer0.000Not reported0.000.00Not reported
Part 2, Group 3: NSCLC PD-L1 Low, Naïve25.000Not reported2.0860.89Not reported
Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low26.471Not reported10.6745.41Not reported
Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High33.333Not reported7.3762.95Not reported
Month 12
Values in percentage of participants · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Part 1: AMG 820 + Pem 200 mg0.000Not reported0.000.00Not reported
Part 2, Group 1: CRC MMR-proficient5.396Not reported1.3613.77Not reported
Part 2, Group 2: Pancreatic Cancer0.000Not reported0.000.00Not reported
Part 2, Group 3: NSCLC PD-L1 Low, Naïve0.000Not reported0.000.00Not reported
Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low6.618Not reported0.7721.97Not reported
Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High33.333Not reported7.3762.95Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.23
        upper Limit
        31.40
        value
        10.476
      2. group Id
        OG001
        lower Limit
        5.99
        upper Limit
        24.04
        value
        13.490
      3. group Id
        OG002
        lower Limit
        0.00
        upper Limit
        0.00
        value
        0.000
      4. group Id
        OG003
        lower Limit
        2.08
        upper Limit
        60.89
        value
        25.000
      5. group Id
        OG004
        lower Limit
        10.67
        upper Limit
        45.41
        value
        26.471
      6. group Id
        OG005
        lower Limit
        7.37
        upper Limit
        62.95
        value
        33.333
    title
    Month 6
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.00
        upper Limit
        0.00
        value
        0.000
      2. group Id
        OG001
        lower Limit
        1.36
        upper Limit
        13.77
        value
        5.396
      3. group Id
        OG002
        lower Limit
        0.00
        upper Limit
        0.00
        value
        0.000
      4. group Id
        OG003
        lower Limit
        0.00
        upper Limit
        0.00
        value
        0.000
      5. group Id
        OG004
        lower Limit
        0.77
        upper Limit
        21.97
        value
        6.618
      6. group Id
        OG005
        lower Limit
        7.37
        upper Limit
        62.95
        value
        33.333
    title
    Month 12
denoms
  1. counts
    1. group Id
      OG000
      value
      15
    2. group Id
      OG001
      value
      41
    3. group Id
      OG002
      value
      31
    4. group Id
      OG003
      value
      4
    5. group Id
      OG004
      value
      19
    6. 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
  1. 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
  2. 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
  3. 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
  4. 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
  5. 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
  6. 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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Preserved source evidence · Not medical advice