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NCT04985604 · OUTCOME

Duration of Progression Free Survival

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

Progression free survival was defined as the interval from the date of the first dose to the first occurrence of radiographic disease progression based on RECIST 1.1 or RANO criteria or death due to any cause, whichever occurs earlier. Progression free survival was estimated using Kaplan-Meier method.

Analysis population: Efficacy Analysis Set comprises of all participants who received at least one dose of study drug and have measurable disease as determined by the Investigator at baseline.

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 Cohort8
Tissue Agnostic Cohort15

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Melanoma Cohort5.5Not reported1.812.5Not reported
Tissue Agnostic Cohort5.5Not reported1.7NAThe 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. group Id
        OG000
        lower Limit
        1.8
        upper Limit
        12.5
        value
        5.5
      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
        1.7
        upper Limit
        NA
        value
        5.5
denoms
  1. counts
    1. group Id
      OG000
      value
      8
    2. group Id
      OG001
      value
      15
    units
    Participants
description
Progression free survival was defined as the interval from the date of the first dose to the first occurrence of radiographic disease progression based on RECIST 1.1 or RANO criteria or death due to any cause, whichever occurs earlier. Progression free survival 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
Efficacy Analysis Set comprises of all participants who received at least one dose of study drug and have measurable disease as determined by the Investigator at baseline.
reporting Status
POSTED
time Frame
Up to 23 months
title
Duration of Progression Free Survival
type
SECONDARY
unit Of Measure
Months

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Preserved source evidence · Not medical advice