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NCT05023980 · OUTCOME

Arm A Compared to Arm B: Duration of Response (DOR), Assessed by IRC

A Study of Pirtobrutinib (LOXO-305) Versus Bendamustine Plus Rituximab (BR) in Untreated Patients With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) · Source last updated 2026-09-25

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 first documented response until the first documented disease progression or death (up to 35 months)

What was measured

DoR, as assessed by IRC, is defined as the time from the date of the first documented response (CR, CRi, nPR, or PR) until the first date of the documentation of disease progression as per iwCLL 2018 criteria, or the date of death from any cause, whichever occurs first.

Analysis population: All randomized participants who achieved ORR.

Groups in this outcome

Arm A - Pirtobrutinib

Participants received pirtobrutinib 200 milligrams (mg) orally once daily in continuous 28-day cycles until disease progression or unacceptable toxicity.

Arm B - Bendamustine Plus Rituximab

Participants received bendamustine 90 milligrams per square meter (mg/m²) intravenously on Days 1 and 2 of each 28-day cycle (Cycles 1-6) plus rituximab 375 mg/m² intravenously on Cycle 1 Day 1, then 500 mg/m² on Day 1 of Cycles 2-6. Eligible participants in Arm B crossed over to receive pirtobrutinib following independent review committee (IRC)-confirmed progressive disease (PD).

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

Analysis denominator · Participants

GroupSource count
Arm A - Pirtobrutinib133
Arm B - Bendamustine Plus Rituximab114

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm A - PirtobrutinibNANot reportedNANAThe median and 95% confidence interval were not reached due to insufficient number of events at the time of data cutoff.
Arm B - Bendamustine Plus Rituximab29.86Not reported28.32NAThe upper limit of the 95% confidence interval could not be estimated due to insufficient number of events beyond the median at time of data cutoff.

Source statistical analyses

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

  1. ci Lower Limit
    0.089
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.356
    estimate Comment
    The HR and 95% CI were estimated from a stratified Cox proportional hazards model.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <.0001
    p Value Comment
    The 2-sided nominal p-value was calculated based on a stratified log-rank test.
    param Type
    Hazard Ratio (HR)
    param Value
    0.178
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.089
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.356
    estimate Comment
    The HR and 95% CI were estimated from a stratified Cox proportional hazards model.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <.0001
    p Value Comment
    The 2-sided nominal p-value was calculated based on a stratified log-rank test.
    param Type
    Hazard Ratio (HR)
    param Value
    0.178
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. comment
        The median and 95% confidence interval were not reached due to insufficient number of events at the time of data cutoff.
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      2. comment
        The upper limit of the 95% confidence interval could not be estimated due to insufficient number of events beyond the median at time of data cutoff.
        group Id
        OG001
        lower Limit
        28.32
        upper Limit
        NA
        value
        29.86
denoms
  1. counts
    1. group Id
      OG000
      value
      133
    2. group Id
      OG001
      value
      114
    units
    Participants
description
DoR, as assessed by IRC, is defined as the time from the date of the first documented response (CR, CRi, nPR, or PR) until the first date of the documentation of disease progression as per iwCLL 2018 criteria, or the date of death from any cause, whichever occurs first.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received pirtobrutinib 200 milligrams (mg) orally once daily in continuous 28-day cycles until disease progression or unacceptable toxicity.
    id
    OG000
    title
    Arm A - Pirtobrutinib
  2. description
    Participants received bendamustine 90 milligrams per square meter (mg/m²) intravenously on Days 1 and 2 of each 28-day cycle (Cycles 1-6) plus rituximab 375 mg/m² intravenously on Cycle 1 Day 1, then 500 mg/m² on Day 1 of Cycles 2-6. Eligible participants in Arm B crossed over to receive pirtobrutinib following independent review committee (IRC)-confirmed progressive disease (PD).
    id
    OG001
    title
    Arm B - Bendamustine Plus Rituximab
param Type
MEDIAN
population Description
All randomized participants who achieved ORR.
reporting Status
POSTED
time Frame
From first documented response until the first documented disease progression or death (up to 35 months)
title
Arm A Compared to Arm B: Duration of Response (DOR), Assessed by IRC
type
SECONDARY
unit Of Measure
Months

Download exact source JSON → · Snapshot ctgov-results-aad7e863b8b06225cd4e94e7

Preserved source evidence · Not medical advice