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ROAR

Dabrafenib plus trametinib in patients with BRAF V600E-mutant low-grade and high-grade glioma (ROAR): a multicentre, open-label, single-arm, phase 2, basket trial

Phase 2N = 58NCT02034110

Population
Adults aged 18 years or older with BRAF V600E-mutant recurrent or progressive high-grade glioma (45 patients, 31 with glioblastoma) or low-grade glioma (13 patients); ECOG performance status 0 to 2
Design
Open-label, single-arm phase 2 basket trial (glioma cohorts reported): dabrafenib 150 mg twice daily plus trametinib 2 mg once daily until unacceptable toxicity, disease progression or death; primary endpoint investigator-assessed objective response rate in the evaluable intention-to-treat population; interim analysis 16 (data cutoff 14 September 2020)
Primary endpoint
ORR
Arms
  • Dabrafenib plus trametinib, high-grade glioma cohort (experimental, n = 45): Dabrafenib 150 mg twice daily plus trametinib 2 mg once daily
  • Dabrafenib plus trametinib, low-grade glioma cohort (experimental, n = 13): Dabrafenib 150 mg twice daily plus trametinib 2 mg once daily
People
Wen PY
Show the numbers
Results reported for ROAR
EndpointAnalysisDabrafenib plus trametinib, high-grade glioma cohort / Dabrafenib plus trametinib, low-grade glioma cohortControlEffect
ORRHigh-grade glioma cohort (n=45)Investigator-assessed objective response (complete plus partial response, RANO high-grade glioma criteria)primarymedian follow-up 12.7 monthsWen 202233% (20–49%)—15 of 45 patients: 3 complete responses and 12 partial responses. The cohort included 31 patients with glioblastoma; response in the glioblastoma subset is not given in the abstract. Interim analysis 16, data cutoff 14 September 2020.
ORRLow-grade glioma cohort (n=13)Investigator-assessed objective response (complete plus partial plus minor response, RANO low-grade glioma criteria)primarymedian follow-up 32.2 monthsWen 202269% (39–91%)—9 of 13 patients: 1 complete response, 6 partial responses and 2 minor responses. Interim analysis 16, data cutoff 14 September 2020.
Results reported for ROAR
EndpointAnalysisDabrafenib plus trametinib, high-grade glioma cohort / Dabrafenib plus trametinib, low-grade glioma cohortControlEffect
ORRHigh-grade glioma cohort (n=45)Investigator-assessed objective response (complete plus partial response, RANO high-grade glioma criteria)primarymedian follow-up 12.7 monthsWen 202233% (20–49%)—15 of 45 patients: 3 complete responses and 12 partial responses. The cohort included 31 patients with glioblastoma; response in the glioblastoma subset is not given in the abstract. Interim analysis 16, data cutoff 14 September 2020.
ORRLow-grade glioma cohort (n=13)Investigator-assessed objective response (complete plus partial plus minor response, RANO low-grade glioma criteria)primarymedian follow-up 32.2 monthsWen 202269% (39–91%)—9 of 13 patients: 1 complete response, 6 partial responses and 2 minor responses. Interim analysis 16, data cutoff 14 September 2020.
Primary publication: Wen PY, Stein A, van den Bent M, De Greve J, Wick A, de Vos FYFL, et al. Dabrafenib plus trametinib in patients with BRAF(V600E)-mutant low-grade and high-grade glioma (ROAR): a multicentre, open-label, single-arm, phase 2, basket trial. Lancet Oncol. 2022;23(1):53-64. PubMedDOI

Appears in

Sources

  1. Wen PY, Stein A, van den Bent M, De Greve J, Wick A, de Vos FYFL, et al. Dabrafenib plus trametinib in patients with BRAF(V600E)-mutant low-grade and high-grade glioma (ROAR): a multicentre, open-label, single-arm, phase 2, basket trial. Lancet Oncol. 2022;23(1):53-64.

    PubMedDOI