On May 29, 2018 Oncoceutics, Inc. reported that two abstracts will be presented at the 2018 Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) that will highlight clinical success of the company’s lead compound in treating high-grade gliomas (HGG), including those that harbor the H3 K27M mutation (Press release, Oncoceutics, MAY 29, 2018, View Source [SID1234558368]).
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The first abstract, entitled "Integrated clinical experience with ONC201 in H3 K27M glioma," describes preliminary clinical data indicating ONC201 induces durable radiographic regressions and clinical benefit in patients with HGG that harbor the H3 K27M mutation. This mutation is prevalent among certain types of brain tumors that develop in children and young adults and is known to confer one of the most dismal and uniformly lethal prognoses amongst HGG. There is no proven medical therapy for these patients. The integrated cohort of H3 K27M-mutant glioma patients who have received ONC201 that will be reported at the meeting include children and adults with different tumor locations. The durability of regressions and clinical benefit will be reported, which is an important measure of efficacy in this disease that is consistent with the immunostimulatory activity of ONC201 that was recently reported in the Journal of Clinical Investigation. ONC201 is currently being evaluated in pediatric and adult H3 K27M-mutant gliomas in three ongoing clinical trials at several institutions around the United States: NCT03416530, NCT03295396, NCT02525692.
The second abstract, entitled "Intratumoral activity of ONC201 in adult recurrent glioblastoma patients" describes the concentrations, targeted signaling pathways, and apoptosis associated with ONC201 directly within tumors that have been surgically removed from adult recurrent glioblastoma patients who have received two doses ONC201. These results serve as an important complement to macroscopic clinical imaging by enabling microscopic studies that demonstrate the drug is inducing the intended therapeutic impact that causes tumor cells to undergo cell death.
In addition to the two abstracts focused on HGG, there is another abstract that reports the safety and pharmacodynamics of ONC201 in advanced solid tumor patients. Additional results support the conclusion that weekly, oral ONC201 is well-tolerated and results in prolonged stable disease, intratumoral apoptotic signaling and immunomodulatory activity.
The abstracts are listed below.
2059. Integrated clinical experience with ONC201 in H3 K27M glioma. Presented Saturday, June 2, 2018.
E14034. Intratumoral activity of ONC201 in adult recurrent glioblastoma patients.
2595. Safety and pharmacodynamics of the DRD2 antagonist ONC201 in advanced solid tumor patients with weekly oral administration. Presented Monday, June 4, 2018,