NCT02564900 · OUTCOME

Progression-free Survival Following Treatment With DS-8201a in Participants With Advanced Solid Malignant Tumors (Dose Expansion Phases)

Study of DS-8201a in Subjects With Advanced Solid Malignant Tumors · Source last updated 2024-01-22

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: From 6 months postdose of last participant up to 3 years 5 months

What was measured

Progression-free survival (PFS) by independent central review was defined as the time from the date of enrollment to the earlier of the dates of the first objective documentation of disease progression (as per RECIST v1.1) or death due to any cause. Progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions. HER2-positive other solid tumors included participants with salivary/submandibular/parotid gland (8 participants), breast with HER2-mutation (2 participants), endometrial (2 participants), esophageal (2 participants), Paget's disease (2 participants), cholangiocarcinoma (1 participant), extraskeletal myxoide chondrosarcoma (1 participant), gallbladder (1 participant), pancreatic (1 participant), small intestine (1 participant), uterine cervix (1 participant) and HER2-low gastric/GEJ (1 participant who received 5.4 mg/kg) cancer.

Analysis population: PFS was assessed in the Intent-to-Treat Analysis Set.

Groups in this outcome

Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg

Participants with HER2-overexpressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).

Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg

Participants with HER2-overexpressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).

Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg

Participants with HER2-low expressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).

Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg

Participants with HER2-low expressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).

Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg

Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).

Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg

Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).

Dose Expansion: HER2-expressing NSCLC Tumors

Participants with HER2-expressing NSCLC tumors received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).

Dose Expansion: HER2-expressing Colorectal Tumors

Participants with HER2-expressing colorectal tumors received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).

Dose Expansion: HER2-expressing Other Solid Tumors

Participants with any other HER2-expressing solid tumor other than breast or gastric or any tumor with HER2 mutation received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).

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
Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg	51
Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg	67
Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg	21
Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg	33
Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg	19
Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg	25
Dose Expansion: HER2-expressing NSCLC Tumors	18
Dose Expansion: HER2-expressing Colorectal Tumors	20
Dose Expansion: HER2-expressing Other Solid Tumors	23

Reported measurements

Source class 1

Values in months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg	13.7	Not reported	8.5	19.6	Not reported
Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg	14.1	Not reported	8.5	NA	Missing upper bound is related to right-censored data. Last time point censored and estimate is essentially infinity, therefore it is NA.
Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg	NA	Not reported	2.7	NA	Median and 95% confidence interval were not calculable due to insufficient number of participants with events.
Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg	11.1	Not reported	5.0	NA	Missing upper bound is related to right-censored data. Last time point censored and estimate is essentially infinity, therefore it is NA.
Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg	4.3	Not reported	2.6	8.6	Not reported
Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg	8.2	Not reported	4.2	11.0	Not reported
Dose Expansion: HER2-expressing NSCLC Tumors	11.3	Not reported	7.2	14.3	Not reported
Dose Expansion: HER2-expressing Colorectal Tumors	4.0	Not reported	2.7	5.6	Not reported
Dose Expansion: HER2-expressing Other Solid Tumors	11.0	Not reported	2.8	NA	Missing upper bound is related to right-censored data. Last time point censored and estimate is essentially infinity, therefore it is NA.

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
8.5
upper Limit
19.6
value
13.7
comment
Missing upper bound is related to right-censored data. Last time point censored and estimate is essentially infinity, therefore it is NA.
group Id
OG001
lower Limit
8.5
upper Limit
NA
value
14.1
comment
Median and 95% confidence interval were not calculable due to insufficient number of participants with events.
group Id
OG002
lower Limit
2.7
upper Limit
NA
value
NA
comment
Missing upper bound is related to right-censored data. Last time point censored and estimate is essentially infinity, therefore it is NA.
group Id
OG003
lower Limit
5.0
upper Limit
NA
value
11.1
group Id
OG004
lower Limit
2.6
upper Limit
8.6
value
4.3
group Id
OG005
lower Limit
4.2
upper Limit
11.0
value
8.2
group Id
OG006
lower Limit
7.2
upper Limit
14.3
value
11.3
group Id
OG007
lower Limit
2.7
upper Limit
5.6
value
4.0
comment
Missing upper bound is related to right-censored data. Last time point censored and estimate is essentially infinity, therefore it is NA.
group Id
OG008
lower Limit
2.8
upper Limit
NA
value
11.0

denoms

counts
group Id
OG000
value
51
group Id
OG001
value
67
group Id
OG002
value
21
group Id
OG003
value
33
group Id
OG004
value
19
group Id
OG005
value
25
group Id
OG006
value
18
group Id
OG007
value
20
group Id
OG008
value
23
units
Participants

description

dispersion Type

95% Confidence Interval

groups

description
Participants with HER2-overexpressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
id
OG000
title
Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg
description
Participants with HER2-overexpressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
id
OG001
title
Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg
description
Participants with HER2-low expressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).
id
OG002
title
Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg
description
Participants with HER2-low expressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
id
OG003
title
Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg
description
Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
id
OG004
title
Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg
description
Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
id
OG005
title
Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg
description
Participants with HER2-expressing NSCLC tumors received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
id
OG006
title
Dose Expansion: HER2-expressing NSCLC Tumors
description
Participants with HER2-expressing colorectal tumors received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
id
OG007
title
Dose Expansion: HER2-expressing Colorectal Tumors
description
Participants with any other HER2-expressing solid tumor other than breast or gastric or any tumor with HER2 mutation received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).
id
OG008
title
Dose Expansion: HER2-expressing Other Solid Tumors

param Type

MEDIAN

population Description

PFS was assessed in the Intent-to-Treat Analysis Set.

reporting Status

POSTED

time Frame

From 6 months postdose of last participant up to 3 years 5 months

title

Progression-free Survival Following Treatment With DS-8201a in Participants With Advanced Solid Malignant Tumors (Dose Expansion Phases)

type

SECONDARY

unit Of Measure

months

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Preserved source evidence · Not medical advice