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NCT03329690 · OUTCOME

Objective Response Rate and Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set)

DS-8201a in Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing Gastric Cancer [DESTINY-Gastric01] · Source last updated 2022-03-18

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
From randomization to first documented objective response, up to 36 months postdose

What was measured

The Objective Response Rate (ORR) is the percentage of participants who achieved a best overall response of Complete Response (CR) or Partial Response (PR), assessed by Independent Central Review (ICR) based on RECIST version 1.1. The best overall response is the best overall response (BOR) recorded from the start of the study treatment until the end of treatment and includes CR, PR, stable disease (SD), progressive disease (PD) and not evaluable (NE) as assessed by Investigator based on RECIST version 1.1. CR was defined as a disappearance of all target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, and SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD (at least a 20% increase in the sum of diameters of target lesions). Confirmed ORR and BOR (confirmed by ICR) are reported.

Analysis population: Best overall response was assessed in the Exploratory Cohorts in the Intent-to-Treat Analysis Set.

Groups in this outcome

Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a

Non-randomized participants with HER2 IHC 2+/ISH- advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every three weeks.

Exploratory: Naïve HER2 IHC 1+, DS-8201a

Non-randomized participants with HER2 IHC 1+ advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every 3 weeks.

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

Analysis denominator · Participants

GroupSource count
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a21
Exploratory: Naïve HER2 IHC 1+, DS-8201a22

Reported measurements

Confirmed Objective response rate (ORR), 25 months (DCO: Nov 8, 2019)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a5Not reportedNot reportedNot reportedNot reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a2Not reportedNot reportedNot reportedNot reported
Confirmed Objective response rate (ORR), 36 months (DCO: Dec 11, 2020)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a5Not reportedNot reportedNot reportedNot reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a2Not reportedNot reportedNot reportedNot reported
Confirmed Complete response (CR), 25 months (DCO: Nov 8, 2019)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a0Not reportedNot reportedNot reportedNot reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a0Not reportedNot reportedNot reportedNot reported
Confirmed Complete response (CR), 36 months (DCO: Dec 11, 2020)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a0Not reportedNot reportedNot reportedNot reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a0Not reportedNot reportedNot reportedNot reported
Confirmed Partial response (PR), 25 months (DCO: Nov 8, 2019)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a5Not reportedNot reportedNot reportedNot reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a2Not reportedNot reportedNot reportedNot reported
Confirmed Partial response (PR), 36 months (DCO: Dec 11, 2020)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a5Not reportedNot reportedNot reportedNot reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a2Not reportedNot reportedNot reportedNot reported
Confirmed Stable disease (SD), 25 months (DCO: Nov 8, 2019)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a12Not reportedNot reportedNot reportedNot reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a13Not reportedNot reportedNot reportedNot reported
Confirmed Stable disease (SD), 36 months (DCO: Dec 11, 2020)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a12Not reportedNot reportedNot reportedNot reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a13Not reportedNot reportedNot reportedNot reported
Confirmed Progressive disease (PD), 25 months (DCO: Nov 8, 2019)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a3Not reportedNot reportedNot reportedNot reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a6Not reportedNot reportedNot reportedNot reported
Confirmed Progressive disease (PD), 36 months (DCO: Dec 11, 2020)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a3Not reportedNot reportedNot reportedNot reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a6Not reportedNot reportedNot reportedNot reported
Inevaluable, 25 months (DCO: Nov 8, 2019)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a1Not reportedNot reportedNot reportedNot reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a1Not reportedNot reportedNot reportedNot reported
Inevaluable, 36 months (DCO: Dec 11, 2020)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a1Not reportedNot reportedNot reportedNot reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        2
    title
    Confirmed Objective response rate (ORR), 25 months (DCO: Nov 8, 2019)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        2
    title
    Confirmed Objective response rate (ORR), 36 months (DCO: Dec 11, 2020)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    Confirmed Complete response (CR), 25 months (DCO: Nov 8, 2019)
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    Confirmed Complete response (CR), 36 months (DCO: Dec 11, 2020)
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        2
    title
    Confirmed Partial response (PR), 25 months (DCO: Nov 8, 2019)
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        2
    title
    Confirmed Partial response (PR), 36 months (DCO: Dec 11, 2020)
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        12
      2. group Id
        OG001
        value
        13
    title
    Confirmed Stable disease (SD), 25 months (DCO: Nov 8, 2019)
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        12
      2. group Id
        OG001
        value
        13
    title
    Confirmed Stable disease (SD), 36 months (DCO: Dec 11, 2020)
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        6
    title
    Confirmed Progressive disease (PD), 25 months (DCO: Nov 8, 2019)
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        6
    title
    Confirmed Progressive disease (PD), 36 months (DCO: Dec 11, 2020)
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
    title
    Inevaluable, 25 months (DCO: Nov 8, 2019)
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
    title
    Inevaluable, 36 months (DCO: Dec 11, 2020)
denoms
  1. counts
    1. group Id
      OG000
      value
      21
    2. group Id
      OG001
      value
      22
    units
    Participants
description
The Objective Response Rate (ORR) is the percentage of participants who achieved a best overall response of Complete Response (CR) or Partial Response (PR), assessed by Independent Central Review (ICR) based on RECIST version 1.1. The best overall response is the best overall response (BOR) recorded from the start of the study treatment until the end of treatment and includes CR, PR, stable disease (SD), progressive disease (PD) and not evaluable (NE) as assessed by Investigator based on RECIST version 1.1. CR was defined as a disappearance of all target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, and SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD (at least a 20% increase in the sum of diameters of target lesions). Confirmed ORR and BOR (confirmed by ICR) are reported.
groups
  1. description
    Non-randomized participants with HER2 IHC 2+/ISH- advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every three weeks.
    id
    OG000
    title
    Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a
  2. description
    Non-randomized participants with HER2 IHC 1+ advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every 3 weeks.
    id
    OG001
    title
    Exploratory: Naïve HER2 IHC 1+, DS-8201a
param Type
COUNT_OF_PARTICIPANTS
population Description
Best overall response was assessed in the Exploratory Cohorts in the Intent-to-Treat Analysis Set.
reporting Status
POSTED
time Frame
From randomization to first documented objective response, up to 36 months postdose
title
Objective Response Rate and Best Overall Response Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set)
type
SECONDARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice