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NCT02713529 · OUTCOME

Time to Progression (TTP) for Participants Who Had Progressive Disease

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
MEAN
Unit
month
Interval / dispersion
Full Range
Time frame
Day 1 up to 14.4 months (max time to censoring)

What was measured

Time to progression was defined as the time from first dose of AMG 820 until first documented progressive disease per irRECIST divided by 365.25 days/12.

Analysis population: Safety Analysis Set

Groups in this outcome

Part 1: AMG 820 + Pem

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 + Pem10
Part 2, Group 1: CRC MMR-proficient29
Part 2, Group 2: Pancreatic Cancer13
Part 2, Group 3: NSCLC PD-L1 Low, Naïve3
Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low8
Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High4

Reported measurements

Source class 1
Values in month · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part 1: AMG 820 + Pem2.1865Not reported0.4605.552Not reported
Part 2, Group 1: CRC MMR-proficient3.0691Not reported0.5598.411Not reported
Part 2, Group 2: Pancreatic Cancer2.3878Not reported0.2964.698Not reported
Part 2, Group 3: NSCLC PD-L1 Low, Naïve4.6762Not reported2.0706.604Not reported
Part 2, Group 4a: Refractory / Relapsing NSCLC PD-L1 Low6.0863Not reported1.15011.992Not reported
Part 2, Group 4b: Refractory/Relapsing NSCLC PD-L1 High7.7864Not reported1.93813.667Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.460
        upper Limit
        5.552
        value
        2.1865
      2. group Id
        OG001
        lower Limit
        0.559
        upper Limit
        8.411
        value
        3.0691
      3. group Id
        OG002
        lower Limit
        0.296
        upper Limit
        4.698
        value
        2.3878
      4. group Id
        OG003
        lower Limit
        2.070
        upper Limit
        6.604
        value
        4.6762
      5. group Id
        OG004
        lower Limit
        1.150
        upper Limit
        11.992
        value
        6.0863
      6. group Id
        OG005
        lower Limit
        1.938
        upper Limit
        13.667
        value
        7.7864
denoms
  1. counts
    1. group Id
      OG000
      value
      10
    2. group Id
      OG001
      value
      29
    3. group Id
      OG002
      value
      13
    4. group Id
      OG003
      value
      3
    5. group Id
      OG004
      value
      8
    6. group Id
      OG005
      value
      4
    units
    Participants
description
Time to progression was defined as the time from first dose of AMG 820 until first documented progressive disease per irRECIST divided by 365.25 days/12.
dispersion Type
Full Range
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
  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
MEAN
population Description
Safety Analysis Set
reporting Status
POSTED
time Frame
Day 1 up to 14.4 months (max time to censoring)
title
Time to Progression (TTP) for Participants Who Had Progressive Disease
type
SECONDARY
unit Of Measure
month

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Preserved source evidence · Not medical advice