NCT03465722 · OUTCOME

Overall Survival (OS) in Patients With Advanced GIST Treated With Avapritinib Compared to Patients Treated With Regorafenib

(VOYAGER) Study of Avapritinib vs Regorafenib in Patients With Locally Advanced Unresectable or Metastatic GIST · Source last updated 2022-10-06

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: 24 Months

What was measured

To evaluate overall survival (OS) in patients with advanced GIST treated with avapritinib compared to patients treated with regorafenib

Groups in this outcome

Avapritinib

300 mg PO QD avapritinib: Avapritinib tablets for oral administration. Avapritinib will be dosed at 300 mg once daily, continuously.

Regorafinib

160 mg PO QD regorafenib: Regorafenib tablets for oral administration. Regorafenib will be dosed at 160 mg once daily for 3 weeks out of every 4 weeks (ie. 3 weeks on/1 week off).

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
Avapritinib	240
Regorafinib	236

Reported measurements

Source class 1

Values in months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Avapritinib	19.2	Not reported	19.2	NA	Since the primary endpoint of statistically significant improvement in PFS was not met patients are not being followed for OS. The upper bound of the confidence interval is not estimable by the Kaplan-Meier analysis due to the short follow-up time.
Regorafinib	17.4	Not reported	15.8	NA	Since the primary endpoint of statistically significant improvement in PFS was not met patients are not being followed for OS. The upper bound of the confidence interval is not estimable by the Kaplan-Meier analysis due to the short follow-up time.

Complete source fields

classes

categories
measurements
comment
Since the primary endpoint of statistically significant improvement in PFS was not met patients are not being followed for OS. The upper bound of the confidence interval is not estimable by the Kaplan-Meier analysis due to the short follow-up time.
group Id
OG000
lower Limit
19.2
upper Limit
NA
value
19.2
comment
Since the primary endpoint of statistically significant improvement in PFS was not met patients are not being followed for OS. The upper bound of the confidence interval is not estimable by the Kaplan-Meier analysis due to the short follow-up time.
group Id
OG001
lower Limit
15.8
upper Limit
NA
value
17.4

denoms

counts
group Id
OG000
value
240
group Id
OG001
value
236
units
Participants

description

To evaluate overall survival (OS) in patients with advanced GIST treated with avapritinib compared to patients treated with regorafenib

dispersion Type

95% Confidence Interval

groups

description
300 mg PO QD avapritinib: Avapritinib tablets for oral administration. Avapritinib will be dosed at 300 mg once daily, continuously.
id
OG000
title
Avapritinib
description
160 mg PO QD regorafenib: Regorafenib tablets for oral administration. Regorafenib will be dosed at 160 mg once daily for 3 weeks out of every 4 weeks (ie. 3 weeks on/1 week off).
id
OG001
title
Regorafinib

param Type

MEDIAN

reporting Status

POSTED

time Frame

24 Months

title

Overall Survival (OS) in Patients With Advanced GIST Treated With Avapritinib Compared to Patients Treated With Regorafenib

type

SECONDARY

unit Of Measure

months

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

Preserved source evidence · Not medical advice