Dordaviprone Shows Promise in Recurrent H3 K27M-Mutant Glioma: Updated Phase 2 Data
Key Insights
Dordaviprone demonstrates a 28% overall response rate in recurrent H3 K27M-mutant diffuse midline glioma (search) using RANO 2.0 criteria.
The median time to response with dordaviprone was 4.6 months, with a median duration of response of 10.4 months.
Chimerix plans to include these updated RANO 2.0 results in a New Drug Application to Australian regulators.
Chimerix has announced updated Phase 2 data for dordaviprone (ONC201) in patients with recurrent H3 K27M-mutant diffuse midline glioma (search) (DMG). The data, assessed using the Response Assessment in Neuro-Oncology (RANO) 2.0 criteria, showed an overall response rate of 28%. These findings will be presented at the 2024 Society for Neuro-Oncology (SNO) Annual Meeting in Houston, TX.
The updated analysis demonstrates a median time to response of 4.6 months and a median duration of response of 10.4 months. Allen Melemed, MD, Chief Medical Officer at Chimerix, stated that the company plans to include these RANO 2.0 results in their upcoming New Drug Application to Australian regulators.
RANO 2.0, a recently established response assessment criteria for gliomas, incorporates an integrated quantitative assessment of both enhancing and non-enhancing disease, as well as minor responses. Patrick Y. Wen, MD, Director of the Center for Neuro-Oncology at Dana-Farber Cancer Institute, noted that minor responses in midline structures can have disproportionate clinical benefit, including meaningful improvement in neurological symptoms and quality of life.
Additional Presentations at SNO
Chimerix will also present additional research at the SNO meeting:
- Response by RANO 2.0 criteria in ONC201 (dordaviprone)-treated patients with recurrent H3 K27M-mutant diffuse midline glioma (Abstract Code: CTNI-54, November 22, 2024)
- Allosteric mitochondrial ClpP agonist ONC206 alters stress response, metabolic and epigenetic profiles to elicit anti-cancer efficacy in high-grade gliomas (Abstract Code: EXTH-37, November 22, 2024)
- Safety of ONC201 treatment in patients with previously treated H3 K27M-mutant glioma: results from ONC028, an ongoing compassionate use program (Abstract Code: NCOG-07, November 23, 2024)
- Early reduction in MRI diffusion apparent diffusion coefficient (ADC) strongly predicts long term response to ONC201 therapy in patient with H3K27M-DMG (Abstract Code: NIMG-29, November 23, 2024)
About Dordaviprone
Dordaviprone (ONC201) is Chimerix's most advanced clinical-stage development program, targeting H3 K27M (search)-mutant glioma (search). Chimerix is focused on developing medicines to improve and extend the lives of patients facing deadly diseases.