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NCT04985604 · OUTCOME

Duration of Response (DOR) in Participants With Best Overall Response

Tovorafenib (DAY101) Monotherapy for Patients With Melanoma and Other Solid Tumors · Source last updated 2025-10-02

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
Up to 23 months

What was measured

Duration of response was defined as the interval from the date of the first documentation of tumor response (CR or PR) that was subsequently confirmed by investigator assessment to the date of first occurrence of radiographic disease progression based on RECIST 1.1 or RANO criteria or death due to any cause, whichever occurs earlier. DOR was estimated using Kaplan-Meier method.

Analysis population: Participants in the Efficacy Analysis Set who have a confirmed response of CR or PR.

Groups in this outcome

Melanoma Cohort

Adult participants (≥ 18 years) were administered Tovorafenib 600 mg orally (PO) once weekly (QW).

Tissue Agnostic Cohort

Adult participants (≥ 18 years) were administered Tovorafenib 600 mg PO QW.

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

Analysis denominator · Participants

GroupSource count
Melanoma Cohort4
Tissue Agnostic Cohort6

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Melanoma Cohort5.6Not reported3.0NAThe upper bound of the 95% confidence interval was not estimable due to insufficient number of participants with events at the tail of the Kaplan-Meier curve.
Tissue Agnostic Cohort9.2Not reported3.5NAThe upper bound of the 95% confidence interval was not estimable due to insufficient number of participants with events at the tail of the Kaplan-Meier curve.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        The upper bound of the 95% confidence interval was not estimable due to insufficient number of participants with events at the tail of the Kaplan-Meier curve.
        group Id
        OG000
        lower Limit
        3.0
        upper Limit
        NA
        value
        5.6
      2. comment
        The upper bound of the 95% confidence interval was not estimable due to insufficient number of participants with events at the tail of the Kaplan-Meier curve.
        group Id
        OG001
        lower Limit
        3.5
        upper Limit
        NA
        value
        9.2
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    2. group Id
      OG001
      value
      6
    units
    Participants
description
Duration of response was defined as the interval from the date of the first documentation of tumor response (CR or PR) that was subsequently confirmed by investigator assessment to the date of first occurrence of radiographic disease progression based on RECIST 1.1 or RANO criteria or death due to any cause, whichever occurs earlier. DOR was estimated using Kaplan-Meier method.
dispersion Type
95% Confidence Interval
groups
  1. description
    Adult participants (≥ 18 years) were administered Tovorafenib 600 mg orally (PO) once weekly (QW).
    id
    OG000
    title
    Melanoma Cohort
  2. description
    Adult participants (≥ 18 years) were administered Tovorafenib 600 mg PO QW.
    id
    OG001
    title
    Tissue Agnostic Cohort
param Type
MEDIAN
population Description
Participants in the Efficacy Analysis Set who have a confirmed response of CR or PR.
reporting Status
POSTED
time Frame
Up to 23 months
title
Duration of Response (DOR) in Participants With Best Overall Response
type
SECONDARY
unit Of Measure
Months

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Preserved source evidence · Not medical advice