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NCT02903914 · OUTCOME

Objective Response Rate (ORR)

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
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
Until disease progression/study discontinuation (up to approximately 5 years)

What was measured

ORR was defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1) as the percentage of participants with a confirmed best overall response of complete response (CR) or partial response (PR) at any post-Baseline visits prior to first disease progression and alternative cancer therapy use. 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 was evaluated using modified RECIST criteria. Confidence intervals were calculated based on the exact method for binomial distributions (Clopper Pearson). Two participants evaluable for PFS were not evaluable for response.

Analysis population: Response Efficacy Evaluable Population (REEP): received ≥1 dose of INCB001158 or pembrolizumab, completed a Baseline scan, and met ≥1 protocol-defined criteria. Part 1c participants had renal impairment and received INCB001158 50 mg + pembrolizumab, which was half the recommended Phase 2 dose 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.

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: 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.

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 mg6
Part 1A: INCB001158 75 mg7
Part 1A: INCB001158 100 mg6
Part 1A: INCB001158 150 mg6
Part 1B: INCB001158 50 mg + Pembrolizumab10
Part 1B: INCB001158 75 mg + Pembrolizumab13
Part 1B: INCB001158 100 mg + Pembrolizumab10
Part 2: INCB001158 100 mg73
Part 1c and Part 3: INCB001158 100 mg + Pembrolizumab118

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Part 1A: INCB001158 50 mg0.0Not reported0.045.9Not reported
Part 1A: INCB001158 75 mg0.0Not reported0.041.0Not reported
Part 1A: INCB001158 100 mg0.0Not reported0.045.9Not reported
Part 1A: INCB001158 150 mg0.0Not reported0.045.9Not reported
Part 1B: INCB001158 50 mg + Pembrolizumab10.0Not reported0.344.5Not reported
Part 1B: INCB001158 75 mg + Pembrolizumab7.7Not reported0.236.0Not reported
Part 1B: INCB001158 100 mg + Pembrolizumab0.0Not reported0.030.8Not reported
Part 2: INCB001158 100 mg1.4Not reported0.07.4Not reported
Part 1c and Part 3: INCB001158 100 mg + Pembrolizumab11.0Not reported6.018.1Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.0
        upper Limit
        45.9
        value
        0.0
      2. group Id
        OG001
        lower Limit
        0.0
        upper Limit
        41.0
        value
        0.0
      3. group Id
        OG002
        lower Limit
        0.0
        upper Limit
        45.9
        value
        0.0
      4. group Id
        OG003
        lower Limit
        0.0
        upper Limit
        45.9
        value
        0.0
      5. group Id
        OG004
        lower Limit
        0.3
        upper Limit
        44.5
        value
        10.0
      6. group Id
        OG005
        lower Limit
        0.2
        upper Limit
        36.0
        value
        7.7
      7. group Id
        OG006
        lower Limit
        0.0
        upper Limit
        30.8
        value
        0.0
      8. group Id
        OG007
        lower Limit
        0.0
        upper Limit
        7.4
        value
        1.4
      9. group Id
        OG008
        lower Limit
        6.0
        upper Limit
        18.1
        value
        11.0
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    2. group Id
      OG001
      value
      7
    3. group Id
      OG002
      value
      6
    4. group Id
      OG003
      value
      6
    5. group Id
      OG004
      value
      10
    6. group Id
      OG005
      value
      13
    7. group Id
      OG006
      value
      10
    8. group Id
      OG007
      value
      73
    9. group Id
      OG008
      value
      118
    units
    Participants
description
ORR was defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1) as the percentage of participants with a confirmed best overall response of complete response (CR) or partial response (PR) at any post-Baseline visits prior to first disease progression and alternative cancer therapy use. 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 was evaluated using modified RECIST criteria. Confidence intervals were calculated based on the exact method for binomial distributions (Clopper Pearson). Two participants evaluable for PFS were not evaluable for response.
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.
    id
    OG008
    title
    Part 1c and Part 3: INCB001158 100 mg + Pembrolizumab
param Type
NUMBER
population Description
Response Efficacy Evaluable Population (REEP): received ≥1 dose of INCB001158 or pembrolizumab, completed a Baseline scan, and met ≥1 protocol-defined criteria. Part 1c participants had renal impairment and received INCB001158 50 mg + pembrolizumab, which was half the recommended Phase 2 dose 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.
reporting Status
POSTED
time Frame
Until disease progression/study discontinuation (up to approximately 5 years)
title
Objective Response Rate (ORR)
type
SECONDARY
unit Of Measure
percentage of participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice