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NCT02760498 · OUTCOME

PFS by Independent Central Review for Participants With Evaluable PD-L1 Assays

Study of REGN2810 in Patients With Advanced Cutaneous Squamous Cell Carcinoma · Source last updated 2025-05-28

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 approximately 65 months (treatment period + follow-up including survival follow-up)

What was measured

PFS was measured from time of enrollment until the first date of recurrent or progressive disease, or death due to any cause. Expression level of PD-L1 was assessed in tumor biopsy samples. -PD: increase of ≥ 25% (WHO criteria) in the sum of the products of perpendicular longest dimensions of target lesion(s) and/or the appearance of new lesions.

Analysis population: The biomarker analysis set (BAS) included all participants in the FAS who had samples evaluable for PD-L1 assay. Here, 'Overall number of participants analyzed' signifies participants who are evaluable for this outcome measure and "Number analyzed" is the number of participants in each row category. Only Group 6 was planned for this outcome measure.

Groups in this outcome

Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W

Participants received cemiplimab 350 mg IV Q3W during each 9-week treatment cycle, for up to 108 weeks (12 cycles).

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

Analysis denominator · Participants

GroupSource count
Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W96

Reported measurements

PD-L1 < 1%

Analysis denominator · Participants

GroupSource count
Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W37
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W10.7Not reported3.015.3Not reported
PD-L1 >= 1%

Analysis denominator · Participants

GroupSource count
Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W59
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W16.6Not reported4.0NANot reached due to insufficient number of events
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3.0
        upper Limit
        15.3
        value
        10.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        37
      units
      Participants
    title
    PD-L1 < 1%
  2. categories
    1. measurements
      1. comment
        Not reached due to insufficient number of events
        group Id
        OG000
        lower Limit
        4.0
        upper Limit
        NA
        value
        16.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        59
      units
      Participants
    title
    PD-L1 >= 1%
denoms
  1. counts
    1. group Id
      OG000
      value
      96
    units
    Participants
description
PFS was measured from time of enrollment until the first date of recurrent or progressive disease, or death due to any cause. Expression level of PD-L1 was assessed in tumor biopsy samples. -PD: increase of ≥ 25% (WHO criteria) in the sum of the products of perpendicular longest dimensions of target lesion(s) and/or the appearance of new lesions.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received cemiplimab 350 mg IV Q3W during each 9-week treatment cycle, for up to 108 weeks (12 cycles).
    id
    OG000
    title
    Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W
param Type
MEDIAN
population Description
The biomarker analysis set (BAS) included all participants in the FAS who had samples evaluable for PD-L1 assay. Here, 'Overall number of participants analyzed' signifies participants who are evaluable for this outcome measure and "Number analyzed" is the number of participants in each row category. Only Group 6 was planned for this outcome measure.
reporting Status
POSTED
time Frame
Up to approximately 65 months (treatment period + follow-up including survival follow-up)
title
PFS by Independent Central Review for Participants With Evaluable PD-L1 Assays
type
SECONDARY
unit Of Measure
months

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice