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NCT03395197 · OUTCOME

BICR Assessed rPFS Per RECIST 1.1 in Patients With DDR Deficiencies - Part 2

Talazoparib + Enzalutamide vs. Enzalutamide Monotherapy in mCRPC · Source last updated 2026-09-08

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
From the start of treatment to the time of first documented progression, or death (maximum up to 38 months)

What was measured

rPFS is defined as the time from the date of randomization to first objective evidence of radiographic progression as assessed in soft tissue per RECIST 1.1, or death, whichever occurs first. Soft tissue disease status was assessed at regular intervals during the course of the study by CT of chest and CT or MRI of abdomen and pelvis. Results as of 03 Oct 2022 are reported for this outcome measure.

Analysis population: Included DDR-deficient participants randomized to double-blind study treatment in Part 2 regardless of whether or not treatment was administered.

Groups in this outcome

Part 2 Participants With DDR Deficiencies: Talazoparib+Enzalutamide

Participants with DDR deficiencies were randomized to receive talazoparib 0.5 mg QD in combination with enzalutamide 160 mg QD (up to a maximum of 169.86 weeks for both talazoparib and enzalutamide as of 03 Oct 2022).

Part 2 Participants With DDR Deficiencies: Placebo+Enzalutamide

Participants with DDR deficiencies were randomized to receive placebo QD in combination with enzalutamide 160 mg QD (up to a maximum of 157 weeks for both placebo and enzalutamide as of 03 Oct 2022).

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 2 Participants With DDR Deficiencies: Talazoparib+Enzalutamide200
Part 2 Participants With DDR Deficiencies: Placebo+Enzalutamide199

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Part 2 Participants With DDR Deficiencies: Talazoparib+EnzalutamideNANot reported21.9NANA indicates not estimated due to less than half of participants meeting the criterion as of data cutoff date (03 Oct 2022).
Part 2 Participants With DDR Deficiencies: Placebo+Enzalutamide13.8Not reported11.016.7Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    0.328
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.610
    estimate Comment
    Hazard ratio was based on Cox proportional hazards model; under proportional hazards, hazard ratio \< 1 indicates reduction in hazard rate in favor of Talazoparib+Enzalutamide compared to Placebo+Enzalutamide.
    group Description
    The following statistical hypotheses was tested to address the primary objectives: H02: HRrPFS+ ≥1 vs H12: HRrPFS+ \<1, where HRrPFS and HRrPFS+ are the hazard ratios (talazoparib in combination with enzalutamide vs. placebo in combination with enzalutamide) of rPFS based on BICR assessment in the DDR deficient population for Part 2 Cohort 2.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    p Value Comment
    1-sided
    param Type
    Hazard Ratio (HR)
    param Value
    0.447
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.328
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.610
    estimate Comment
    Hazard ratio was based on Cox proportional hazards model; under proportional hazards, hazard ratio \< 1 indicates reduction in hazard rate in favor of Talazoparib+Enzalutamide compared to Placebo+Enzalutamide.
    group Description
    The following statistical hypotheses was tested to address the primary objectives: H02: HRrPFS+ ≥1 vs H12: HRrPFS+ \<1, where HRrPFS and HRrPFS+ are the hazard ratios (talazoparib in combination with enzalutamide vs. placebo in combination with enzalutamide) of rPFS based on BICR assessment in the DDR deficient population for Part 2 Cohort 2.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    p Value Comment
    1-sided
    param Type
    Hazard Ratio (HR)
    param Value
    0.447
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. comment
        NA indicates not estimated due to less than half of participants meeting the criterion as of data cutoff date (03 Oct 2022).
        group Id
        OG000
        lower Limit
        21.9
        upper Limit
        NA
        value
        NA
      2. group Id
        OG001
        lower Limit
        11.0
        upper Limit
        16.7
        value
        13.8
denoms
  1. counts
    1. group Id
      OG000
      value
      200
    2. group Id
      OG001
      value
      199
    units
    Participants
description
rPFS is defined as the time from the date of randomization to first objective evidence of radiographic progression as assessed in soft tissue per RECIST 1.1, or death, whichever occurs first. Soft tissue disease status was assessed at regular intervals during the course of the study by CT of chest and CT or MRI of abdomen and pelvis. Results as of 03 Oct 2022 are reported for this outcome measure.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants with DDR deficiencies were randomized to receive talazoparib 0.5 mg QD in combination with enzalutamide 160 mg QD (up to a maximum of 169.86 weeks for both talazoparib and enzalutamide as of 03 Oct 2022).
    id
    OG000
    title
    Part 2 Participants With DDR Deficiencies: Talazoparib+Enzalutamide
  2. description
    Participants with DDR deficiencies were randomized to receive placebo QD in combination with enzalutamide 160 mg QD (up to a maximum of 157 weeks for both placebo and enzalutamide as of 03 Oct 2022).
    id
    OG001
    title
    Part 2 Participants With DDR Deficiencies: Placebo+Enzalutamide
param Type
MEDIAN
population Description
Included DDR-deficient participants randomized to double-blind study treatment in Part 2 regardless of whether or not treatment was administered.
reporting Status
POSTED
time Frame
From the start of treatment to the time of first documented progression, or death (maximum up to 38 months)
title
BICR Assessed rPFS Per RECIST 1.1 in Patients With DDR Deficiencies - Part 2
type
PRIMARY
unit Of Measure
Months

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Preserved source evidence · Not medical advice