Therapeutic Response

H3-3A p.K28M status confers therapeutic sensitivity to Dordaviprone in patients with Diffuse Midline Glioma.

Statements

Source and description

Modeyso (dordaviprone) [package insert]. FDA. The U.S. Food and Drug Administration (FDA) granted accelerated approval to dordaviprone adult and pediatric patients 1 year of age and older with diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy. This indication is approved under accelerated approval based on response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. The underlying trials, including ONC018 (NCT03134131), assessed H3 K27M status through either IHC or sequencing for patient eligibility. The H3 K27M nomenclature refers to the H3-3A:c.83A>T p.K28M (K27M) variant.