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NCT05023980 · OUTCOME

Arm A Compared to Arm B: Progression-free Survival (PFS), Assessed by Independent Review Committee (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 randomization until documented disease progression or death (up to 40 months)

What was measured

PFS, as assessed by IRC, is defined as the time from randomization until documented disease progression as per iwCLL (International Workshop on Chronic Lymphocytic Leukemia) 2018 criteria, or death from any cause, whichever occurs first.

Analysis population: All randomized participants.

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 - Pirtobrutinib141
Arm B - Bendamustine Plus Rituximab141

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 Rituximab33.54Not reported32.72NAThe 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
    0.107
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.367
    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 p-value was calculated based on a stratified log-rank test.
    param Type
    Hazard Ratio (HR)
    param Value
    0.199
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.107
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.367
    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 p-value was calculated based on a stratified log-rank test.
    param Type
    Hazard Ratio (HR)
    param Value
    0.199
    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
        32.72
        upper Limit
        NA
        value
        33.54
denoms
  1. counts
    1. group Id
      OG000
      value
      141
    2. group Id
      OG001
      value
      141
    units
    Participants
description
PFS, as assessed by IRC, is defined as the time from randomization until documented disease progression as per iwCLL (International Workshop on Chronic Lymphocytic Leukemia) 2018 criteria, or 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.
reporting Status
POSTED
time Frame
From randomization until documented disease progression or death (up to 40 months)
title
Arm A Compared to Arm B: Progression-free Survival (PFS), Assessed by Independent Review Committee (IRC)
type
PRIMARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice