NCT03329690 · OUTCOME

Objective Response Rate and Best Overall Response Based on Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable 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 Investigator 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). Unconfirmed ORR and BOR (not confirmed by Investigator) and confirmed ORR and BOR (confirmed by Investigator) are reported.

Analysis population: Objective response rate (ORR) and best overall response (BOR) were assessed in the Response Evaluable Set.

Groups in this outcome

DS-8201a

Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive DS-8201a once every 3 weeks.

Physician's Choice Irinotecan

Physician's Choice Paclitaxel

Physician's Choice Overall

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

Group	Source count
DS-8201a	119
Physician's Choice Irinotecan	51
Physician's Choice Paclitaxel	5
Physician's Choice Overall	56
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a	19
Exploratory: Naïve HER2 IHC 1+, DS-8201a	21

Reported measurements

Unconfirmed Objective response rate (ORR), 25 months (DCO: Nov 8, 2019)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
DS-8201a	60	Not reported	Not reported	Not reported	Not reported
Physician's Choice Irinotecan	7	Not reported	Not reported	Not reported	Not reported
Physician's Choice Paclitaxel	1	Not reported	Not reported	Not reported	Not reported
Physician's Choice Overall	8	Not reported	Not reported	Not reported	Not reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a	10	Not reported	Not reported	Not reported	Not reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a	5	Not reported	Not reported	Not reported	Not reported

Unconfirmed Objective response rate (ORR), 36 months (DCO: Dec 11, 2020)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
DS-8201a	60	Not reported	Not reported	Not reported	Not reported
Physician's Choice Irinotecan	7	Not reported	Not reported	Not reported	Not reported
Physician's Choice Paclitaxel	1	Not reported	Not reported	Not reported	Not reported
Physician's Choice Overall	8	Not reported	Not reported	Not reported	Not reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a	10	Not reported	Not reported	Not reported	Not reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a	5	Not reported	Not reported	Not reported	Not reported

Unconfirmed Complete response (CR), 25 months (DCO: Nov 8, 2019)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
DS-8201a	4	Not reported	Not reported	Not reported	Not reported
Physician's Choice Irinotecan	0	Not reported	Not reported	Not reported	Not reported
Physician's Choice Paclitaxel	0	Not reported	Not reported	Not reported	Not reported
Physician's Choice Overall	0	Not reported	Not reported	Not reported	Not reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a	0	Not reported	Not reported	Not reported	Not reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a	0	Not reported	Not reported	Not reported	Not reported

Unconfirmed Complete response (CR), 36 months (DCO: Dec 11, 2020)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
DS-8201a	4	Not reported	Not reported	Not reported	Not reported
Physician's Choice Irinotecan	0	Not reported	Not reported	Not reported	Not reported
Physician's Choice Paclitaxel	0	Not reported	Not reported	Not reported	Not reported
Physician's Choice Overall	0	Not reported	Not reported	Not reported	Not reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a	0	Not reported	Not reported	Not reported	Not reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a	0	Not reported	Not reported	Not reported	Not reported

Unconfirmed Partial response (PR), 25 months (DCO: Nov 8, 2019)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
DS-8201a	56	Not reported	Not reported	Not reported	Not reported
Physician's Choice Irinotecan	7	Not reported	Not reported	Not reported	Not reported
Physician's Choice Paclitaxel	1	Not reported	Not reported	Not reported	Not reported
Physician's Choice Overall	8	Not reported	Not reported	Not reported	Not reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a	10	Not reported	Not reported	Not reported	Not reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a	5	Not reported	Not reported	Not reported	Not reported

Unconfirmed Partial response (PR), 36 months (DCO: Dec 11, 2020)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
DS-8201a	56	Not reported	Not reported	Not reported	Not reported
Physician's Choice Irinotecan	7	Not reported	Not reported	Not reported	Not reported
Physician's Choice Paclitaxel	1	Not reported	Not reported	Not reported	Not reported
Physician's Choice Overall	8	Not reported	Not reported	Not reported	Not reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a	10	Not reported	Not reported	Not reported	Not reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a	5	Not reported	Not reported	Not reported	Not reported

Unconfirmed Stable disease (SD), 25 months (DCO: Nov 8, 2019)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
DS-8201a	42	Not reported	Not reported	Not reported	Not reported
Physician's Choice Irinotecan	27	Not reported	Not reported	Not reported	Not reported
Physician's Choice Paclitaxel	1	Not reported	Not reported	Not reported	Not reported
Physician's Choice Overall	28	Not reported	Not reported	Not reported	Not reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a	7	Not reported	Not reported	Not reported	Not reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a	8	Not reported	Not reported	Not reported	Not reported

Unconfirmed Stable disease (SD), 36 months (DCO: Dec 11, 2020)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
DS-8201a	42	Not reported	Not reported	Not reported	Not reported
Physician's Choice Irinotecan	27	Not reported	Not reported	Not reported	Not reported
Physician's Choice Paclitaxel	1	Not reported	Not reported	Not reported	Not reported
Physician's Choice Overall	28	Not reported	Not reported	Not reported	Not reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a	7	Not reported	Not reported	Not reported	Not reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a	8	Not reported	Not reported	Not reported	Not reported

Unconfirmed Progressive disease (PD), 25 months (DCO: Nov 8, 2019)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
DS-8201a	15	Not reported	Not reported	Not reported	Not reported
Physician's Choice Irinotecan	15	Not reported	Not reported	Not reported	Not reported
Physician's Choice Paclitaxel	2	Not reported	Not reported	Not reported	Not reported
Physician's Choice Overall	17	Not reported	Not reported	Not reported	Not reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a	2	Not reported	Not reported	Not reported	Not reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a	8	Not reported	Not reported	Not reported	Not reported

Unconfirmed Progressive disease (PD), 36 months (DCO: Dec 11, 2020)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
DS-8201a	15	Not reported	Not reported	Not reported	Not reported
Physician's Choice Irinotecan	15	Not reported	Not reported	Not reported	Not reported
Physician's Choice Paclitaxel	2	Not reported	Not reported	Not reported	Not reported
Physician's Choice Overall	17	Not reported	Not reported	Not reported	Not reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a	2	Not reported	Not reported	Not reported	Not reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a	8	Not reported	Not reported	Not reported	Not reported

Unconfirmed Not evaluable (NE), 25 months (DCO: Nov 8, 2019)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
DS-8201a	2	Not reported	Not reported	Not reported	Not reported
Physician's Choice Irinotecan	2	Not reported	Not reported	Not reported	Not reported
Physician's Choice Paclitaxel	1	Not reported	Not reported	Not reported	Not reported
Physician's Choice Overall	3	Not reported	Not reported	Not reported	Not reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a	0	Not reported	Not reported	Not reported	Not reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a	0	Not reported	Not reported	Not reported	Not reported

Unconfirmed Not evaluable (NE), 36 months (DCO: Dec 11, 2020)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
DS-8201a	2	Not reported	Not reported	Not reported	Not reported
Physician's Choice Irinotecan	2	Not reported	Not reported	Not reported	Not reported
Physician's Choice Paclitaxel	1	Not reported	Not reported	Not reported	Not reported
Physician's Choice Overall	3	Not reported	Not reported	Not reported	Not reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a	0	Not reported	Not reported	Not reported	Not reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a	0	Not reported	Not reported	Not reported	Not reported

Confirmed Objective response rate (ORR), 25 months (DCO: Nov 8, 2019)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
DS-8201a	49	Not reported	Not reported	Not reported	Not reported
Physician's Choice Irinotecan	5	Not reported	Not reported	Not reported	Not reported
Physician's Choice Paclitaxel	1	Not reported	Not reported	Not reported	Not reported
Physician's Choice Overall	6	Not reported	Not reported	Not reported	Not reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a	8	Not reported	Not reported	Not reported	Not reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a	3	Not reported	Not reported	Not reported	Not reported

Confirmed Objective response rate (ORR), 36 months (DCO: Dec 11, 2020)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
DS-8201a	51	Not reported	Not reported	Not reported	Not reported
Physician's Choice Irinotecan	5	Not reported	Not reported	Not reported	Not reported
Physician's Choice Paclitaxel	1	Not reported	Not reported	Not reported	Not reported
Physician's Choice Overall	6	Not reported	Not reported	Not reported	Not reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a	8	Not reported	Not reported	Not reported	Not reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a	3	Not reported	Not reported	Not reported	Not reported

Confirmed Complete response (CR), 25 months (DCO: Nov 8, 2019)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
DS-8201a	3	Not reported	Not reported	Not reported	Not reported
Physician's Choice Irinotecan	0	Not reported	Not reported	Not reported	Not reported
Physician's Choice Paclitaxel	0	Not reported	Not reported	Not reported	Not reported
Physician's Choice Overall	0	Not reported	Not reported	Not reported	Not reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a	0	Not reported	Not reported	Not reported	Not reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a	0	Not reported	Not reported	Not reported	Not reported

Confirmed Complete response (CR), 36 months (DCO: Dec 11, 2020)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
DS-8201a	4	Not reported	Not reported	Not reported	Not reported
Physician's Choice Irinotecan	0	Not reported	Not reported	Not reported	Not reported
Physician's Choice Paclitaxel	0	Not reported	Not reported	Not reported	Not reported
Physician's Choice Overall	0	Not reported	Not reported	Not reported	Not reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a	0	Not reported	Not reported	Not reported	Not reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a	0	Not reported	Not reported	Not reported	Not reported

Confirmed Partial response (PR), 25 months (DCO: Nov 8, 2019)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
DS-8201a	46	Not reported	Not reported	Not reported	Not reported
Physician's Choice Irinotecan	5	Not reported	Not reported	Not reported	Not reported
Physician's Choice Paclitaxel	1	Not reported	Not reported	Not reported	Not reported
Physician's Choice Overall	6	Not reported	Not reported	Not reported	Not reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a	8	Not reported	Not reported	Not reported	Not reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a	3	Not reported	Not reported	Not reported	Not reported

Confirmed Partial response (PR), 36 months (DCO: Dec 11, 2020)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
DS-8201a	47	Not reported	Not reported	Not reported	Not reported
Physician's Choice Irinotecan	5	Not reported	Not reported	Not reported	Not reported
Physician's Choice Paclitaxel	1	Not reported	Not reported	Not reported	Not reported
Physician's Choice Overall	6	Not reported	Not reported	Not reported	Not reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a	8	Not reported	Not reported	Not reported	Not reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a	3	Not reported	Not reported	Not reported	Not reported

Confirmed Stable disease (SD), 25 months (DCO: Nov 8, 2019)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
DS-8201a	53	Not reported	Not reported	Not reported	Not reported
Physician's Choice Irinotecan	28	Not reported	Not reported	Not reported	Not reported
Physician's Choice Paclitaxel	1	Not reported	Not reported	Not reported	Not reported
Physician's Choice Overall	29	Not reported	Not reported	Not reported	Not reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a	9	Not reported	Not reported	Not reported	Not reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a	10	Not reported	Not reported	Not reported	Not reported

Confirmed Stable disease (SD), 36 months (DCO: Dec 11, 2020)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
DS-8201a	51	Not reported	Not reported	Not reported	Not reported
Physician's Choice Irinotecan	28	Not reported	Not reported	Not reported	Not reported
Physician's Choice Paclitaxel	1	Not reported	Not reported	Not reported	Not reported
Physician's Choice Overall	29	Not reported	Not reported	Not reported	Not reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a	9	Not reported	Not reported	Not reported	Not reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a	10	Not reported	Not reported	Not reported	Not reported

Confirmed Progressive disease (PD), 25 months (DCO: Nov 8, 2019)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
DS-8201a	15	Not reported	Not reported	Not reported	Not reported
Physician's Choice Irinotecan	16	Not reported	Not reported	Not reported	Not reported
Physician's Choice Paclitaxel	2	Not reported	Not reported	Not reported	Not reported
Physician's Choice Overall	18	Not reported	Not reported	Not reported	Not reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a	2	Not reported	Not reported	Not reported	Not reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a	8	Not reported	Not reported	Not reported	Not reported

Confirmed Progressive disease (PD), 36 months (DCO: Dec 11, 2020)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
DS-8201a	15	Not reported	Not reported	Not reported	Not reported
Physician's Choice Irinotecan	16	Not reported	Not reported	Not reported	Not reported
Physician's Choice Paclitaxel	2	Not reported	Not reported	Not reported	Not reported
Physician's Choice Overall	18	Not reported	Not reported	Not reported	Not reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a	2	Not reported	Not reported	Not reported	Not reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a	8	Not reported	Not reported	Not reported	Not reported

Confirmed Not evaluable (NE), 25 months (DCO: Nov 8, 2019)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
DS-8201a	2	Not reported	Not reported	Not reported	Not reported
Physician's Choice Irinotecan	2	Not reported	Not reported	Not reported	Not reported
Physician's Choice Paclitaxel	1	Not reported	Not reported	Not reported	Not reported
Physician's Choice Overall	3	Not reported	Not reported	Not reported	Not reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a	0	Not reported	Not reported	Not reported	Not reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a	0	Not reported	Not reported	Not reported	Not reported

Confirmed Not evaluable (NE), 36 months (DCO: Dec 11, 2020)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
DS-8201a	2	Not reported	Not reported	Not reported	Not reported
Physician's Choice Irinotecan	2	Not reported	Not reported	Not reported	Not reported
Physician's Choice Paclitaxel	1	Not reported	Not reported	Not reported	Not reported
Physician's Choice Overall	3	Not reported	Not reported	Not reported	Not reported
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a	0	Not reported	Not reported	Not reported	Not reported
Exploratory: Naïve HER2 IHC 1+, DS-8201a	0	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
60
group Id
OG001
value
7
group Id
OG002
value
1
group Id
OG003
value
8
group Id
OG004
value
10
group Id
OG005
value
5
title
Unconfirmed Objective response rate (ORR), 25 months (DCO: Nov 8, 2019)
categories
measurements
group Id
OG000
value
60
group Id
OG001
value
7
group Id
OG002
value
1
group Id
OG003
value
8
group Id
OG004
value
10
group Id
OG005
value
5
title
Unconfirmed Objective response rate (ORR), 36 months (DCO: Dec 11, 2020)
categories
measurements
group Id
OG000
value
4
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
0
title
Unconfirmed Complete response (CR), 25 months (DCO: Nov 8, 2019)
categories
measurements
group Id
OG000
value
4
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
0
title
Unconfirmed Complete response (CR), 36 months (DCO: Dec 11, 2020)
categories
measurements
group Id
OG000
value
56
group Id
OG001
value
7
group Id
OG002
value
1
group Id
OG003
value
8
group Id
OG004
value
10
group Id
OG005
value
5
title
Unconfirmed Partial response (PR), 25 months (DCO: Nov 8, 2019)
categories
measurements
group Id
OG000
value
56
group Id
OG001
value
7
group Id
OG002
value
1
group Id
OG003
value
8
group Id
OG004
value
10
group Id
OG005
value
5
title
Unconfirmed Partial response (PR), 36 months (DCO: Dec 11, 2020)
categories
measurements
group Id
OG000
value
42
group Id
OG001
value
27
group Id
OG002
value
1
group Id
OG003
value
28
group Id
OG004
value
7
group Id
OG005
value
8
title
Unconfirmed Stable disease (SD), 25 months (DCO: Nov 8, 2019)
categories
measurements
group Id
OG000
value
42
group Id
OG001
value
27
group Id
OG002
value
1
group Id
OG003
value
28
group Id
OG004
value
7
group Id
OG005
value
8
title
Unconfirmed Stable disease (SD), 36 months (DCO: Dec 11, 2020)
categories
measurements
group Id
OG000
value
15
group Id
OG001
value
15
group Id
OG002
value
2
group Id
OG003
value
17
group Id
OG004
value
2
group Id
OG005
value
8
title
Unconfirmed Progressive disease (PD), 25 months (DCO: Nov 8, 2019)
categories
measurements
group Id
OG000
value
15
group Id
OG001
value
15
group Id
OG002
value
2
group Id
OG003
value
17
group Id
OG004
value
2
group Id
OG005
value
8
title
Unconfirmed Progressive disease (PD), 36 months (DCO: Dec 11, 2020)
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
2
group Id
OG002
value
1
group Id
OG003
value
3
group Id
OG004
value
0
group Id
OG005
value
0
title
Unconfirmed Not evaluable (NE), 25 months (DCO: Nov 8, 2019)
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
2
group Id
OG002
value
1
group Id
OG003
value
3
group Id
OG004
value
0
group Id
OG005
value
0
title
Unconfirmed Not evaluable (NE), 36 months (DCO: Dec 11, 2020)

denoms

counts
group Id
OG000
value
119
group Id
OG001
value
51
group Id
OG002
value
5
group Id
OG003
value
56
group Id
OG004
value
19
group Id
OG005
value
21
units
Participants

description

groups

description
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive DS-8201a once every 3 weeks.
id
OG000
title
DS-8201a
description
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive irinotecan monotherapy as prescribed by the physician before enrollment.
id
OG001
title
Physician's Choice Irinotecan
description
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive paclitaxel monotherapy as prescribed by the physician before enrollment.
id
OG002
title
Physician's Choice Paclitaxel
description
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive either irinotecan or paclitaxel monotherapy as prescribed by the physician before enrollment.
id
OG003
title
Physician's Choice Overall
description
Non-randomized participants with HER2 IHC 2+/ISH- advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every three weeks.
id
OG004
title
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a
description
Non-randomized participants with HER2 IHC 1+ advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every 3 weeks.
id
OG005
title
Exploratory: Naïve HER2 IHC 1+, DS-8201a

param Type

COUNT_OF_PARTICIPANTS

population Description

Objective response rate (ORR) and best overall response (BOR) were assessed in the Response Evaluable 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 Investigator Assessment Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Response Evaluable Set)

type

SECONDARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice