Chimerix Announces Positive ONC201 Data in Recurrent H3 K27M-mutant Diffuse Midline Glioma to Be Presented at the Society for Neuro-Oncology Annual Meeting
– Plenary Session Presentation on
– Company to Host Conference Call at 8:30 a.m. ET on
These data will be presented by Isabel Arrillaga-Romany, MD, PhD, Director of Neuro-Oncology Clinical Trials,
Key Data Highlights
ONC201 monotherapy exhibited durable and clinically meaningful efficacy in recurrent H3 K27M-mutant diffuse midline glioma (DMG) patients:
- Response Assessment in Neuro-Oncology Criteria for High Grade Gliomas (RANO-HGG) criteria assessed by dual reader blinded independent central review (BICR)
- Overall response rate (ORR): 20% (95% CI: 10 – 34%); including one complete response
- Median duration of response (DOR): 11.2 months (95% CI: 3.8 – not reached)
- Median time to response: 8.3 months (range: 1.9 – 15.9)
- Disease control rate (DCR): 40% (95% CI: 26 – 55%)
- Progression-free survival (PFS): 35% (95% CI: 21 – 49%) at 6 months; 30% (95% CI: 17 – 44%) at 12 months
- Response Assessment in Neuro-Oncology Criteria for Low Grade Gliomas (RANO-LGG) criteria assessed by dual reader BICR
- ORR 26% (95% CI: 15 – 40%)
- Among evaluable patients (those receiving at least 4mg of dexamethasone daily at baseline), 46.7% achieved at least a 50% confirmed reduction in corticosteroid dose
- Among evaluable patients (those with a baseline performance status (KPS/LPS) score of 80 or lower), 20.6% achieved a confirmed improvement, indicative of improved quality of life.
- Overall survival
- 12 months: 57% (95% CI: 41 – 70%)
- 24 months: 35% (95% CI: 21 – 49%)
"The ONC201 data to be presented at SNO show impressive and consistent results in a disease where life expectancy is exceedingly limited. There currently are no effective therapeutic options for patients with recurrent disease after radiation other than palliation. ONC201 results are particularly notable in light of extended wash-out periods required to ensure isolation of ONC201 single agent effect. It sets the stage for future study of ONC201 earlier in treatment," said
"Given the very limited treatment options for patients with recurrent H3 K27M-mutant glioma, we are encouraged by the durable tumor regressions seen in some patients treated with ONC201," said Dr. Arrillaga-Romany.
This cohort was comprised of the first 50 patients enrolled across five ONC201 clinical studies
One serious adverse event was attributed by an investigator as possibly related to ONC201. Full safety data collection and analysis for this cohort is ongoing. Prior safety review of ONC201 identified the most commonly reported adverse events as nausea/vomiting, fatigue and decreased lymphocyte counts.
About Recurrent H3 K27M-mutant Glioma
Recurrent H3 K27M-mutant glioma is a brain cancer with a particularly poor prognosis. Pediatric patients with recurrent glioma that carries the H3 K27M mutation have an even worse prognosis. Diffuse midline gliomas with this mutation are classified as Grade IV by the
Conference Call and Webcast
A live audio webcast of the call will also be available on the Investors section of Chimerix’s website, www.chimerix.com. An archived webcast will be available on the
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 status of Chimerix’s oncology programs, and the results of the 50-patient efficacy analysis of ONC201. Among the factors and risks that could cause actual results to differ materially from those indicated in the forward-looking statements are risks that the current clinical study data for ONC201 will not support accelerated, or any, regulatory approval; the anticipated benefits of the acquisition of
Source: Chimerix, Inc.