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NCT03168438 · OUTCOME

Duration of Response

Letetresgene Autoleucel Engineered T Cells Alone and in Combination With Pembrolizumab in NY-ESO-1 Positive Multiple Myeloma · Source last updated 2022-01-11

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEDIAN
Unit
Months
Interval / dispersion
Full Range
Time frame
Up to 108 weeks

What was measured

Duration of response is defined as the interval between the initial date of the confirmed response (sCR, CR, VGPR, or PR) and the initial assesment date of confirmed progressive disease or death among participants with a confirmed response per IMWG (2016).

Analysis population: Modified ITT Population. Only those participants with a confirmed response per IMWG 2016 were analyzed.

Groups in this outcome

GSK3377794

Eligible participants underwent leukapheresis to manufacture engineered T-cells. Participants then underwent lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed by a single intravenous (IV) infusion of GSK3377794.

GSK3377794+Pembrolizumab

Eligible participants underwent leukapheresis to manufacture engineered T-cells. Participants then underwent lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed by a single IV infusion of GSK3377794 in combination with pembrolizumab 200 milligrams (mg) administered as an IV infusion every 3 weeks up to Week 108.

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

Analysis denominator · Participants

GroupSource count
GSK33777941
GSK3377794+Pembrolizumab2

Reported measurements

Source class 1
Values in Months · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
GSK33777942.1Not reportedNANAFull range is not applicable as only a single participant was analyzed. Median value presented here is the actual duration of response for this single participant.
GSK3377794+Pembrolizumab2.1Not reported2.12.1Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Full range is not applicable as only a single participant was analyzed. Median value presented here is the actual duration of response for this single participant.
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        2.1
      2. group Id
        OG001
        lower Limit
        2.1
        upper Limit
        2.1
        value
        2.1
denoms
  1. counts
    1. group Id
      OG000
      value
      1
    2. group Id
      OG001
      value
      2
    units
    Participants
description
Duration of response is defined as the interval between the initial date of the confirmed response (sCR, CR, VGPR, or PR) and the initial assesment date of confirmed progressive disease or death among participants with a confirmed response per IMWG (2016).
dispersion Type
Full Range
groups
  1. description
    Eligible participants underwent leukapheresis to manufacture engineered T-cells. Participants then underwent lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed by a single intravenous (IV) infusion of GSK3377794.
    id
    OG000
    title
    GSK3377794
  2. description
    Eligible participants underwent leukapheresis to manufacture engineered T-cells. Participants then underwent lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed by a single IV infusion of GSK3377794 in combination with pembrolizumab 200 milligrams (mg) administered as an IV infusion every 3 weeks up to Week 108.
    id
    OG001
    title
    GSK3377794+Pembrolizumab
param Type
MEDIAN
population Description
Modified ITT Population. Only those participants with a confirmed response per IMWG 2016 were analyzed.
reporting Status
POSTED
time Frame
Up to 108 weeks
title
Duration of Response
type
SECONDARY
unit Of Measure
Months

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice