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ONC201 (Dordaviprone) in Recurrent H3 K27M-Mutant Diffuse Midline Glioma

Arrillaga-Romany, Isabel ; Gardner, Sharon L ; Odia, Yazmin ; Aguilera, Dolly ; Allen, Joshua E ; Batchelor, Tracy ; Butowski, Nicholas ; Chen, Clark ; Cloughesy, Timothy ; Cluster, Andrew ; de Groot, John ; Dixit, Karan S ; Graber, Jerome J ; Haggiagi, Aya M ; Harrison, Rebecca A ; Kheradpour, Albert ; Kilburn, Lindsay B ; Kurz, Sylvia C ; Lu, Guangrong ; MacDonald, Tobey J ; Mehta, Minesh ; Melemed, Allen S ; Nghiemphu, Phioanh Leia ; Ramage, Samuel C ; Shonka, Nicole ; Sumrall, Ashley ; Tarapore, Rohinton S ; Taylor, Lynne ; Umemura, Yoshie ; Wen, Patrick Y

Journal of clinical oncology, 2024-05, Vol.42 (13), p.1542-1552 [Periódico revisado por pares]

United States: Wolters Kluwer Health

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Título:
ONC201 (Dordaviprone) in Recurrent H3 K27M-Mutant Diffuse Midline Glioma
Autor: Arrillaga-Romany, Isabel ; Gardner, Sharon L ; Odia, Yazmin ; Aguilera, Dolly ; Allen, Joshua E ; Batchelor, Tracy ; Butowski, Nicholas ; Chen, Clark ; Cloughesy, Timothy ; Cluster, Andrew ; de Groot, John ; Dixit, Karan S ; Graber, Jerome J ; Haggiagi, Aya M ; Harrison, Rebecca A ; Kheradpour, Albert ; Kilburn, Lindsay B ; Kurz, Sylvia C ; Lu, Guangrong ; MacDonald, Tobey J ; Mehta, Minesh ; Melemed, Allen S ; Nghiemphu, Phioanh Leia ; Ramage, Samuel C ; Shonka, Nicole ; Sumrall, Ashley ; Tarapore, Rohinton S ; Taylor, Lynne ; Umemura, Yoshie ; Wen, Patrick Y
Assuntos: Adolescent ; Adult ; Aged ; Brain Neoplasms - drug therapy ; Brain Neoplasms - genetics ; Brain Neoplasms - pathology ; Child ; Child, Preschool ; Female ; Glioma - drug therapy ; Glioma - genetics ; Glioma - pathology ; Histones - genetics ; Humans ; Male ; Middle Aged ; Mutation ; Neoplasm Recurrence, Local - drug therapy ; Neoplasm Recurrence, Local - genetics ; Original Reports ; Pyridones - therapeutic use ; Pyrimidines - adverse effects ; Pyrimidines - therapeutic use ; Young Adult
É parte de: Journal of clinical oncology, 2024-05, Vol.42 (13), p.1542-1552
Notas: ObjectType-Article-1
SourceType-Scholarly Journals-1
ObjectType-Feature-2
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Descrição: Histone 3 (H3) K27M-mutant diffuse midline glioma (DMG) has a dismal prognosis with no established effective therapy beyond radiation. This integrated analysis evaluated single-agent ONC201 (dordaviprone), a first-in-class imipridone, in recurrent H3 K27M-mutant DMG. Fifty patients (pediatric, n = 4; adult, n = 46) with recurrent H3 K27M-mutant DMG who received oral ONC201 monotherapy in four clinical trials or one expanded access protocol were included. Eligible patients had measurable disease by Response Assessment in Neuro-Oncology (RANO) high-grade glioma (HGG) criteria and performance score (PS) ≥60 and were ≥90 days from radiation; pontine and spinal tumors were ineligible. The primary end point was overall response rate (ORR) by RANO-HGG criteria. Secondary end points included duration of response (DOR), time to response (TTR), corticosteroid response, PS response, and ORR by RANO low-grade glioma (LGG) criteria. Radiographic end points were assessed by dual-reader, blinded independent central review. The ORR (RANO-HGG) was 20.0% (95% CI, 10.0 to 33.7). The median TTR was 8.3 months (range, 1.9-15.9); the median DOR was 11.2 months (95% CI, 3.8 to not reached). The ORR by combined RANO-HGG/LGG criteria was 30.0% (95% CI, 17.9 to 44.6). A ≥50% corticosteroid dose reduction occurred in 7 of 15 evaluable patients (46.7% [95% CI, 21.3 to 73.4]); PS improvement occurred in 6 of 34 evaluable patients (20.6% [95% CI, 8.7 to 37.9]). Grade 3 treatment-related treatment-emergent adverse events (TR-TEAEs) occurred in 20.0% of patients; the most common was fatigue (n = 5; 10%); no grade 4 TR-TEAEs, deaths, or discontinuations occurred. ONC201 monotherapy was well tolerated and exhibited durable and clinically meaningful efficacy in recurrent H3 K27M-mutant DMG.
Editor: United States: Wolters Kluwer Health
Idioma: Inglês

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ONC201 (Dordaviprone) in Recurrent H3 K27M-Mutant Diffuse Midline Glioma

United States: Wolters Kluwer Health

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