Chimerix Announces Data Highlighting Clinical Efficacy and Molecular Mechanisms of Response to ONC201 Treatment of H3 K27M-Mutant Diffuse Midline Gliomas Published in "Cancer Discovery"
Patients Treated with ONC201 Demonstrated Median Overall Survival (mOS) of 21.7 Months in the Front-
ONC201 Treatment Disrupts Key Metabolic and Epigenetic Pathways
The manuscript titled, “Clinical efficacy of ONC201 in H3K27M-mutant diffuse midline gliomas is driven by disruption of integrated metabolic and epigenetic pathways,” reports survival analyses of 71 patients with H3 K27M-DMG treated with ONC201 which demonstrated promising results in a patient population with a poor prognosis and few treatment options. In addition to assessing clinical outcomes, the study corroborated mechanistic findings from laboratory models in samples from treated patients that demonstrated the ability of ONC201 to disrupt metabolic pathways and reverse the epigenetic consequence (H3K27me3-loss) of the H3 K27M mutation.
“The survival analyses published today in Cancer Discovery reported that ONC201 frontline treatment, administered post radiation therapy, demonstrated a statistically significant increase in mOS from diagnosis versus historical controls (21.7 months mOS vs. 12 months mOS, p<0.0001). These data are particularly relevant given that enrollment in the ongoing ACTION study occurs in a similar population. Additionally, these data further elucidate the underlying novel mechanism of action for ONC201 in a patient population which has very limited treatment options,” said
“H3K27M-DMG represents one of the most difficult tumors to treat,” said
The complete publication can be accessed here.
About the Phase 3 ACTION Study
The Phase 3 ACTION trial is actively recruiting patients in 11 countries across
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include those relating to, among other things, the relevance of the published survival analyses to the Phase 3 ACTION study, and the confidence and rationale in ONC201’s treatment effect. Among the factors and risks that could cause actual results to differ materially from those indicated in the forward-looking statements are risks related to the timing, completion and outcome of the Phase 3 ACTION study of ONC201; risks associated with repeating positive results obtained in prior preclinical or clinical studies in future studies; and additional risks set forth in the Company's filings with the Securities and Exchange Commission. These forward-looking statements represent the Company's judgment as of the date of this release. The Company disclaims, however, any intent or obligation to update these forward-looking statements.
Source: Chimerix, Inc.