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NCT04195750 · OUTCOME

Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by BICR

A Study of Belzutifan (MK-6482) Versus Everolimus in Participants With Advanced Renal Cell Carcinoma (MK-6482-005) · Source last updated 2026-05-14

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
Up to approximately 31 months

What was measured

ORR is defined as the percentage of participants who have a complete response (CR: Disappearance of all target lesions) or a partial response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. The percentage of participants who experience a CR or PR as assessed by blinded independent central review based on RECIST 1.1 is presented here.

Analysis population: Per protocol, the analysis population consisted of all randomized participants based on the treatment group to which they were randomized. Per protocol, participants enrolled in the Safety Run-In were not randomized and not included in the protocol-specified analyses for any of the outcome measures.

Groups in this outcome

Belzutifan

Randomized participants received 120 mg of belzutifan orally once daily (QD), until disease progression or discontinuation.

Everolimus

Randomized participants received 10 mg of Everolimus orally QD, until disease progression or discontinuation.

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

Analysis denominator · Participants

GroupSource count
Belzutifan374
Everolimus372

Reported measurements

Source class 1
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Belzutifan21.9Not reported17.826.5Not reported
Everolimus3.5Not reported1.95.9Not reported

Source statistical analyses

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

  1. ci Lower Limit
    14.0
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    23.2
    estimate Comment
    Belzutifan minus Everolimus
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    P-value, difference in percentage and associated 95% CI were calculated using Miettinen \& Nurminen method stratified by IMDC Risk Category and Number of prior VEGF/VEGF-Receptor Targeted Therapies for RCC.
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.00001
    p Value Comment
    One-sided p-value for testing. H0: difference in % = 0 versus H1: difference in % \> 0.
    param Type
    Difference in Percentage
    param Value
    18.4
    statistical Method
    Miettinen & Nurminen
Complete source fields
analyses
  1. ci Lower Limit
    14.0
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    23.2
    estimate Comment
    Belzutifan minus Everolimus
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    P-value, difference in percentage and associated 95% CI were calculated using Miettinen \& Nurminen method stratified by IMDC Risk Category and Number of prior VEGF/VEGF-Receptor Targeted Therapies for RCC.
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.00001
    p Value Comment
    One-sided p-value for testing. H0: difference in % = 0 versus H1: difference in % \> 0.
    param Type
    Difference in Percentage
    param Value
    18.4
    statistical Method
    Miettinen & Nurminen
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        17.8
        upper Limit
        26.5
        value
        21.9
      2. group Id
        OG001
        lower Limit
        1.9
        upper Limit
        5.9
        value
        3.5
denoms
  1. counts
    1. group Id
      OG000
      value
      374
    2. group Id
      OG001
      value
      372
    units
    Participants
description
ORR is defined as the percentage of participants who have a complete response (CR: Disappearance of all target lesions) or a partial response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. The percentage of participants who experience a CR or PR as assessed by blinded independent central review based on RECIST 1.1 is presented here.
dispersion Type
95% Confidence Interval
groups
  1. description
    Randomized participants received 120 mg of belzutifan orally once daily (QD), until disease progression or discontinuation.
    id
    OG000
    title
    Belzutifan
  2. description
    Randomized participants received 10 mg of Everolimus orally QD, until disease progression or discontinuation.
    id
    OG001
    title
    Everolimus
param Type
NUMBER
population Description
Per protocol, the analysis population consisted of all randomized participants based on the treatment group to which they were randomized. Per protocol, participants enrolled in the Safety Run-In were not randomized and not included in the protocol-specified analyses for any of the outcome measures.
reporting Status
POSTED
time Frame
Up to approximately 31 months
title
Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by BICR
type
SECONDARY
unit Of Measure
Percentage of Participants

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Preserved source evidence · Not medical advice