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CDRB436G2201 (high-grade glioma cohort)

Phase 2 trial of dabrafenib plus trametinib in relapsed or refractory BRAF V600-mutant paediatric high-grade glioma

Phase 2N = 41NCT02684058

Population
Paediatric patients with previously treated BRAF V600-mutant high-grade glioma; 41 enrolled
Design
Phase 2 single-arm study of dabrafenib plus trametinib; primary objective overall response rate by independent review using Response Assessment in Neuro-Oncology criteria; secondary objectives included investigator-determined response rate, duration of response, progression-free survival, overall survival and safety
Primary endpoint
ORR
Arms
  • Dabrafenib plus trametinib (experimental, n = 41): Dabrafenib plus trametinib; doses not given in the abstract
People
Hargrave DR
Show the numbers
Results reported for CDRB436G2201 (high-grade glioma cohort)
EndpointAnalysisDabrafenib plus trametinibControlEffect
ORREnrolled patients (n=41); analysis population not stated in the abstractIndependently assessed overall response rate by RANO criteriaprimarymedian follow-up 25.1 monthsHargrave 202356% (40–72%)——
DOREnrolled patients (n=41); analysis population not stated in the abstractDuration of response (secondary objective)primaryHargrave 2023median 22.2 months—95% CI 7.6 months to not reached; the upper limit cannot be recorded as a number.
OSEnrolled patients (n=41); analysis population not stated in the abstractOverall survival (secondary objective)primaryHargrave 2023median 32.8 months—95% CI 19.2 months to not reached; the upper limit cannot be recorded as a number.
Results reported for CDRB436G2201 (high-grade glioma cohort)
EndpointAnalysisDabrafenib plus trametinibControlEffect
ORREnrolled patients (n=41); analysis population not stated in the abstractIndependently assessed overall response rate by RANO criteriaprimarymedian follow-up 25.1 monthsHargrave 202356% (40–72%)——
DOREnrolled patients (n=41); analysis population not stated in the abstractDuration of response (secondary objective)primaryHargrave 2023median 22.2 months—95% CI 7.6 months to not reached; the upper limit cannot be recorded as a number.
OSEnrolled patients (n=41); analysis population not stated in the abstractOverall survival (secondary objective)primaryHargrave 2023median 32.8 months—95% CI 19.2 months to not reached; the upper limit cannot be recorded as a number.
Illustrative — modelled from reported values, not trial data. DOR, primary.
0%25%50%75%100%01020304050Months (modelled)
  • Dabrafenib plus trametinib (experimental)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsDabrafenib plus trametinib
0100.0%
1464.6%
2841.7%
4226.9%
5617.4%
Illustrative — modelled from reported values, not trial data. OS, primary.
0%25%50%75%100%020406080Months (modelled)
  • Dabrafenib plus trametinib (experimental)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsDabrafenib plus trametinib
0100.0%
2164.2%
4142.0%
6227.0%
8217.7%
Primary publication: Hargrave DR, Terashima K, Hara J, Kordes UR, Upadhyaya SA, Sahm F, et al. Phase II Trial of Dabrafenib Plus Trametinib in Relapsed/Refractory BRAF V600-Mutant Pediatric High-Grade Glioma. J Clin Oncol. 2023;41(33):5174-5183. PubMedDOI

Appears in

Sources

  1. Hargrave DR, Terashima K, Hara J, Kordes UR, Upadhyaya SA, Sahm F, et al. Phase II Trial of Dabrafenib Plus Trametinib in Relapsed/Refractory BRAF V600-Mutant Pediatric High-Grade Glioma. J Clin Oncol. 2023;41(33):5174-5183.

    PubMedDOI