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NCT02903914 · OUTCOME

Duration of Response (DOR)

Arginase Inhibitor INCB001158 as a Single Agent and in Combination With Immune Checkpoint Therapy in Patients With Advanced/Metastatic Solid Tumors · Source last updated 2025-08-05

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
Until disease progression/study discontinuation (up to approximately 5 years)

What was measured

DOR was defined as the number of months from the date of the first documentation of an objective response (CR or PR per RECIST v1.1) to the date of the first documentation of disease progression or death, whichever occurred first. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. Pleural mesothelioma will be evaluated using modified RECIST criteria. Kaplan-Meier (KM) product-limit estimates with a log-log transformation were used for 95% confidence interval calculation.

Analysis population: REEP. Only participants with CR or PR were analyzed, and only cohorts with ≥5 objective responders were analyzed. Part 1c participants had renal impairment and received INCB001158 50 mg + pembrolizumab (half the RP2D of INCB001158). It was pre-specified to combine Part 1c and Part 3 participants for efficacy analysis based on planned comparable dosing according to renal function. Two participants evaluable for PFS were not evaluable for response.

Groups in this outcome

Part 1A: INCB001158 50 mg

INCB001158 was administered orally at 50 milligrams (mg) twice daily (BID) in participants with advanced/metastatic solid tumors.

Part 1A: INCB001158 75 mg

INCB001158 was administered orally at 75 mg BID in participants with advanced/metastatic solid tumors.

Part 1A: INCB001158 100 mg

INCB001158 was administered orally at 100 mg BID in participants with advanced/metastatic solid tumors.

Part 1A: INCB001158 150 mg

INCB001158 was administered orally at 150 mg BID in participants with advanced/metastatic solid tumors.

Part 1B: INCB001158 50 mg + Pembrolizumab

INCB001158 was administered orally at 50 mg BID in combination with pembrolizumab at 200 mg intravenously (IV) every 3 weeks (Q3W).

Part 1B: INCB001158 75 mg + Pembrolizumab

INCB001158 was administered orally at 75 mg BID in combination with pembrolizumab at 200 mg IV Q3W.

Part 1B: INCB001158 100 mg + Pembrolizumab

INCB001158 was administered orally at 100 mg BID in combination with pembrolizumab at 200 mg IV Q3W.

Part 2: INCB001158 100 mg

INCB001158 was administered orally at 100 mg BID in participants with advanced/metastatic solid tumors.

Part 1c and Part 3, SCCHN: INCB001158 100 mg + Pembrolizumab

INCB001158 was administered orally at 100 mg BID (50 mg BID for Part 1c renally impaired participants) in combination with pembrolizumab at 200 mg IV Q3W to participants with squamous cell carcinoma of the head and neck (SCCHN).

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 1A: INCB001158 50 mg0
Part 1A: INCB001158 75 mg0
Part 1A: INCB001158 100 mg0
Part 1A: INCB001158 150 mg0
Part 1B: INCB001158 50 mg + Pembrolizumab1
Part 1B: INCB001158 75 mg + Pembrolizumab1
Part 1B: INCB001158 100 mg + Pembrolizumab0
Part 2: INCB001158 100 mg1
Part 1c and Part 3, SCCHN: INCB001158 100 mg + Pembrolizumab5

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Part 1B: INCB001158 50 mg + PembrolizumabNANot reportedNANAThe KM estimation method on a sample of \<5 responders is not valid because too few participants were responders.
Part 1B: INCB001158 75 mg + PembrolizumabNANot reportedNANAThe KM estimation method on a sample of \<5 responders is not valid because too few participants were responders.
Part 2: INCB001158 100 mgNANot reportedNANAThe KM estimation method on a sample of \<5 responders is not valid because too few participants were responders.
Part 1c and Part 3, SCCHN: INCB001158 100 mg + Pembrolizumab12.4Not reported4.2NAThe upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        The KM estimation method on a sample of \<5 responders is not valid because too few participants were responders.
        group Id
        OG004
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      2. comment
        The KM estimation method on a sample of \<5 responders is not valid because too few participants were responders.
        group Id
        OG005
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      3. comment
        The KM estimation method on a sample of \<5 responders is not valid because too few participants were responders.
        group Id
        OG007
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      4. comment
        The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
        group Id
        OG008
        lower Limit
        4.2
        upper Limit
        NA
        value
        12.4
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      0
    3. group Id
      OG002
      value
      0
    4. group Id
      OG003
      value
      0
    5. group Id
      OG004
      value
      1
    6. group Id
      OG005
      value
      1
    7. group Id
      OG006
      value
      0
    8. group Id
      OG007
      value
      1
    9. group Id
      OG008
      value
      5
    units
    Participants
description
DOR was defined as the number of months from the date of the first documentation of an objective response (CR or PR per RECIST v1.1) to the date of the first documentation of disease progression or death, whichever occurred first. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. Pleural mesothelioma will be evaluated using modified RECIST criteria. Kaplan-Meier (KM) product-limit estimates with a log-log transformation were used for 95% confidence interval calculation.
dispersion Type
95% Confidence Interval
groups
  1. description
    INCB001158 was administered orally at 50 milligrams (mg) twice daily (BID) in participants with advanced/metastatic solid tumors.
    id
    OG000
    title
    Part 1A: INCB001158 50 mg
  2. description
    INCB001158 was administered orally at 75 mg BID in participants with advanced/metastatic solid tumors.
    id
    OG001
    title
    Part 1A: INCB001158 75 mg
  3. description
    INCB001158 was administered orally at 100 mg BID in participants with advanced/metastatic solid tumors.
    id
    OG002
    title
    Part 1A: INCB001158 100 mg
  4. description
    INCB001158 was administered orally at 150 mg BID in participants with advanced/metastatic solid tumors.
    id
    OG003
    title
    Part 1A: INCB001158 150 mg
  5. description
    INCB001158 was administered orally at 50 mg BID in combination with pembrolizumab at 200 mg intravenously (IV) every 3 weeks (Q3W).
    id
    OG004
    title
    Part 1B: INCB001158 50 mg + Pembrolizumab
  6. description
    INCB001158 was administered orally at 75 mg BID in combination with pembrolizumab at 200 mg IV Q3W.
    id
    OG005
    title
    Part 1B: INCB001158 75 mg + Pembrolizumab
  7. description
    INCB001158 was administered orally at 100 mg BID in combination with pembrolizumab at 200 mg IV Q3W.
    id
    OG006
    title
    Part 1B: INCB001158 100 mg + Pembrolizumab
  8. description
    INCB001158 was administered orally at 100 mg BID in participants with advanced/metastatic solid tumors.
    id
    OG007
    title
    Part 2: INCB001158 100 mg
  9. description
    INCB001158 was administered orally at 100 mg BID (50 mg BID for Part 1c renally impaired participants) in combination with pembrolizumab at 200 mg IV Q3W to participants with squamous cell carcinoma of the head and neck (SCCHN).
    id
    OG008
    title
    Part 1c and Part 3, SCCHN: INCB001158 100 mg + Pembrolizumab
param Type
MEDIAN
population Description
REEP. Only participants with CR or PR were analyzed, and only cohorts with ≥5 objective responders were analyzed. Part 1c participants had renal impairment and received INCB001158 50 mg + pembrolizumab (half the RP2D of INCB001158). It was pre-specified to combine Part 1c and Part 3 participants for efficacy analysis based on planned comparable dosing according to renal function. Two participants evaluable for PFS were not evaluable for response.
reporting Status
POSTED
time Frame
Until disease progression/study discontinuation (up to approximately 5 years)
title
Duration of Response (DOR)
type
SECONDARY
unit Of Measure
months

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Preserved source evidence · Not medical advice