CTNI-54. RESPONSE BY RANO2.0 CRITERIA IN ONC201 (DORDAVIPRONE)-TREATED PATIENTS WITH RECURRENT H3 K27M-MUTANT DIFFUSE MIDLINE GLIOMA
Cloughesy T, Allen J, Arrillaga-Romany I, Barbaro M, Batchelor T, Butowski N, Cluster A, de Groot J, Graber J, Haggiagi A, Kilburn L, Kurz S, Melemed A, Ramage S, Salacz M, Shonka N, Sumrall A, Tarapore R, Taylor L, Wen P. CTNI-54. RESPONSE BY RANO2.0 CRITERIA IN ONC201 (DORDAVIPRONE)-TREATED PATIENTS WITH RECURRENT H3 K27M-MUTANT DIFFUSE MIDLINE GLIOMA. Neuro-Oncology 2024, 26: viii109-viii109. PMCID: PMC11552873, DOI: 10.1093/neuonc/noae165.0421.Peer-Reviewed Original ResearchDiffuse midline gliomaH3 K27M-mutant diffuse midline gliomaH3K27M-mutant diffuse midline gliomaMidline gliomaResponse assessmentTarget lesionsMedian duration of responseMedian time to responseProgression free survival rateDiffuse intrinsic pontine gliomaBlinded independent central reviewAssociated with overall survivalNon-enhancing diseaseDisease control ratePrimary spinal tumorsDuration of responseFree survival rateIntrinsic pontine gliomaImproved performance statusIndependent central reviewClinically meaningful efficacyTime to responseOverall response rateAnti-cancer therapyComplete responseONC201 (Dordaviprone) in Recurrent H3 K27M–Mutant Diffuse Midline Glioma
Arrillaga-Romany I, Gardner S, Odia Y, Aguilera D, Allen J, Batchelor T, Butowski N, Chen C, Cloughesy T, Cluster A, de Groot J, Dixit K, Graber J, Haggiagi A, Harrison R, Kheradpour A, Kilburn L, Kurz S, Lu G, MacDonald T, Mehta M, Melemed A, Nghiemphu P, Ramage S, Shonka N, Sumrall A, Tarapore R, Taylor L, Umemura Y, Wen P. ONC201 (Dordaviprone) in Recurrent H3 K27M–Mutant Diffuse Midline Glioma. Journal Of Clinical Oncology 2024, 42: 1542-1552. PMID: 38335473, PMCID: PMC11095894, DOI: 10.1200/jco.23.01134.Peer-Reviewed Original ResearchConceptsH3 K27M-mutant diffuse midline gliomaDiffuse midline gliomaDuration of responseTime to responseHigh-grade gliomasLow-grade gliomasMidline gliomaMedian duration of responseMedian time to responseTreatment-emergent adverse eventsEnd pointsBlinded independent central reviewCorticosteroid dose reductionIndependent central reviewSecondary end pointsClinically meaningful efficacyRadiographic end pointsSpinal tumorsDose reductionDismal prognosisCentral reviewPerformance scoresCorticosteroid responseResponse assessmentAdverse events