NCT02684058 · OUTCOME

LGG Cohort: Kaplan-Meier Progression-Free Survival (PFS) as Per Central Independent Assessment Using RANO Criteria

Study of Efficacy and Safety of Dabrafenib in Combination With Trametinib in Pediatric Patients With BRAF V600 Mutation Positive LGG or Relapsed or Refractory HGG Tumors · Source last updated 2023-12-13

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: Up to approx. 3 years and up to approx 4.2 years

What was measured

Time from the date of randomization to the date of first documented disease progression as per central independent review assessment using RANO criteria or death due to any cause. Confidence Intervals were estimated using the Brookmeyer Crowley method. Patients who had not progressed or died or had received further anticancer therapy were censored at the date of the last adequate tumor evaluation.

Analysis population: Participants on the LGG cohort to whom study treatment had been assigned by randomization regardless of whether or not treatment was administered. According to the intent to treat principle, patients were analyzed according to the treatment they had been assigned to during the randomization procedure.

Groups in this outcome

LGG Cohort: Dabrafenib and Trametinib

Participants in the LGG cohort randomized to receive dabrafenib (orally, twice daily and dosed based on weight and age) in combination with trametinib (orally, once daily in combination with the first daily dose of dabrafenib and was dosed based on weight)

LGG Cohort: Carboplatin and Vincristine

Participants in the LGG cohort randomized to receive active comparator chemotherapy (carboplatin and vincristine). Participants received one course of induction (10 weeks of chemotherapy with 2 weeks of rest), followed by 8 cycles of maintenance chemotherapy. Participants were allowed to crossover to dabrafenib and trametinib after centrally confirmed and RANO-defined disease progression.

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
LGG Cohort: Dabrafenib and Trametinib	73
LGG Cohort: Carboplatin and Vincristine	37

Reported measurements

Up to approx. 3 years

Values in Months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
LGG Cohort: Dabrafenib and Trametinib	20.1	Not reported	12.8	NA	Not estimable (NA) due to the insufficient number of participants with events
LGG Cohort: Carboplatin and Vincristine	7.4	Not reported	3.6	11.8	Not reported

Up to approx 4.2 years

Values in Months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
LGG Cohort: Dabrafenib and Trametinib	24.9	Not reported	12.9	31.6	Not reported
LGG Cohort: Carboplatin and Vincristine	7.2	Not reported	2.8	11.2	Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

ci Lower Limit
0.17
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.55
group Description
Up to approx. 3 years
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
<0.001
p Value Comment
Log-rank test at an overall one-sided 2.5% level of significance
param Type
Hazard Ratio (HR)
param Value
0.31
statistical Method
Log Rank

Complete source fields

analyses

ci Lower Limit
0.17
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.55
group Description
Up to approx. 3 years
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
<0.001
p Value Comment
Log-rank test at an overall one-sided 2.5% level of significance
param Type
Hazard Ratio (HR)
param Value
0.31
statistical Method
Log Rank

classes

categories
measurements
comment
Not estimable (NA) due to the insufficient number of participants with events
group Id
OG000
lower Limit
12.8
upper Limit
NA
value
20.1
group Id
OG001
lower Limit
3.6
upper Limit
11.8
value
7.4
title
Up to approx. 3 years
categories
measurements
group Id
OG000
lower Limit
12.9
upper Limit
31.6
value
24.9
group Id
OG001
lower Limit
2.8
upper Limit
11.2
value
7.2
title
Up to approx 4.2 years

denoms

counts
group Id
OG000
value
73
group Id
OG001
value
37
units
Participants

description

dispersion Type

95% Confidence Interval

groups

description
Participants in the LGG cohort randomized to receive dabrafenib (orally, twice daily and dosed based on weight and age) in combination with trametinib (orally, once daily in combination with the first daily dose of dabrafenib and was dosed based on weight)
id
OG000
title
LGG Cohort: Dabrafenib and Trametinib
description
Participants in the LGG cohort randomized to receive active comparator chemotherapy (carboplatin and vincristine). Participants received one course of induction (10 weeks of chemotherapy with 2 weeks of rest), followed by 8 cycles of maintenance chemotherapy. Participants were allowed to crossover to dabrafenib and trametinib after centrally confirmed and RANO-defined disease progression.
id
OG001
title
LGG Cohort: Carboplatin and Vincristine

param Type

MEDIAN

population Description

Participants on the LGG cohort to whom study treatment had been assigned by randomization regardless of whether or not treatment was administered. According to the intent to treat principle, patients were analyzed according to the treatment they had been assigned to during the randomization procedure.

reporting Status

POSTED

time Frame

Up to approx. 3 years and up to approx 4.2 years

title

LGG Cohort: Kaplan-Meier Progression-Free Survival (PFS) as Per Central Independent Assessment Using RANO Criteria

type

SECONDARY

unit Of Measure

Months

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Preserved source evidence · Not medical advice