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NCT05023980 · OUTCOME

Arm A Compared to Arm B: Percentage of Participants With Overall Response (ORR), 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
NUMBER
Unit
Percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
From randomization until subsequent anticancer therapy, disease progression or death (up to 40 months)

What was measured

ORR, as assessed by IRC, is defined as number of participants who achieved a best overall response of complete remission (CR), complete remission with an incomplete marrow recovery (CRi), nodular partial remission (nPR) or partial remission (PR) at or before the initiation of subsequent anticancer therapy, disease progression or death, divided by the total number of participants randomized to each treatment arm.

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 Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm A - Pirtobrutinib94.3Not reported89.1397.52Not reported
Arm B - Bendamustine Plus Rituximab80.9Not reported73.3886.99Not reported

Source statistical analyses

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

  1. ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    p Value
    0.0006
    statistical Method
    Cochran-Mantel-Haenszel
Complete source fields
analyses
  1. ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    p Value
    0.0006
    statistical Method
    Cochran-Mantel-Haenszel
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        89.13
        upper Limit
        97.52
        value
        94.3
      2. group Id
        OG001
        lower Limit
        73.38
        upper Limit
        86.99
        value
        80.9
denoms
  1. counts
    1. group Id
      OG000
      value
      141
    2. group Id
      OG001
      value
      141
    units
    Participants
description
ORR, as assessed by IRC, is defined as number of participants who achieved a best overall response of complete remission (CR), complete remission with an incomplete marrow recovery (CRi), nodular partial remission (nPR) or partial remission (PR) at or before the initiation of subsequent anticancer therapy, disease progression or death, divided by the total number of participants randomized to each treatment arm.
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
NUMBER
population Description
All randomized participants.
reporting Status
POSTED
time Frame
From randomization until subsequent anticancer therapy, disease progression or death (up to 40 months)
title
Arm A Compared to Arm B: Percentage of Participants With Overall Response (ORR), Assessed by IRC
type
SECONDARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice