Chimerix Announces Updated Phase 2 Response Assessment of Dordaviprone in Recurrent H3 K27M Glioma at the 2024 SNO Meeting
Chimerix (NASDAQ: CMRX) announced updated Phase 2 response assessment results for dordaviprone in treating recurrent H3 K27M-mutant diffuse midline glioma. Using the new RANO 2.0 criteria, the treatment showed a 28.0% overall response rate, with a median time to response of 4.6 months and a median duration of response of 10.4 months. The company plans to include these updated results in their upcoming New Drug Application to Australian regulators. The findings will be presented at the 2024 Society for Neuro-Oncology Annual Meeting in Houston, along with additional pipeline presentations.
Chimerix (NASDAQ: CMRX) ha annunciato risultati aggiornati della valutazione della risposta della fase 2 per dordaviprone nel trattamento del glioma a diffusione mediana ricorrente con mutazione H3 K27M. Utilizzando i nuovi criteri RANO 2.0, il trattamento ha mostrato un tasso di risposta complessivo del 28,0%, con un tempo mediano per la risposta di 4,6 mesi e una durata mediana della risposta di 10,4 mesi. L'azienda prevede di includere questi risultati aggiornati nella sua prossima domanda di registrazione di un nuovo farmaco presso i regolatori australiani. I risultati saranno presentati al Congresso annuale della Society for Neuro-Oncology del 2024 a Houston, insieme ad ulteriori presentazioni sul pipeline.
Chimerix (NASDAQ: CMRX) anunció resultados actualizados de la evaluación de respuesta de la fase 2 para dordaviprone en el tratamiento del glioma difuso de línea media recurrente con mutación H3 K27M. Utilizando los nuevos criterios RANO 2.0, el tratamiento mostró una tasa de respuesta global del 28.0%, con un tiempo medio para la respuesta de 4.6 meses y una duración media de la respuesta de 10.4 meses. La empresa planea incluir estos resultados actualizados en su próxima Solicitud de Nuevo Medicamento ante los reguladores australianos. Los hallazgos serán presentados en la Reunión Anual de la Sociedad de Neuro-Oncología de 2024 en Houston, junto con otras presentaciones del pipeline.
Chimerix (NASDAQ: CMRX)는 dordaviprone의 재발성 H3 K27M 변이 확산 중선 신경 교종 치료를 위한 2상 반응 평가 결과를 업데이트하여 발표했습니다. 새로운 RANO 2.0 기준을 사용하여 치료는 28.0%의 전체 반응률을 보였으며, 반응까지의 중앙 시간은 4.6개월, 반응 지속 기간의 중앙값은 10.4개월로 나타났습니다. 이 회사는 이러한 업데이트된 결과를 곧 호주 규제 당국에 제출할 신규 의약품 신청서에 포함할 계획입니다. 이 결과는 2024년 휴스턴에서 열리는 신경종양학회 연례 회의에서 추가 파이프라인 발표와 함께 발표될 예정입니다.
Chimerix (NASDAQ: CMRX) a annoncé des résultats mis à jour concernant l'évaluation de réponse de la phase 2 pour dordaviprone dans le traitement du gliome diffus de ligne médiane récurrent avec mutation H3 K27M. En utilisant les nouveaux critères RANO 2.0, le traitement a montré un taux de réponse global de 28,0%, avec un temps médian jusqu'à la réponse de 4,6 mois et une durée médiane de réponse de 10,4 mois. L'entreprise prévoit d'inclure ces résultats mis à jour dans sa prochaine demande de nouveau médicament auprès des autorités australiennes. Les résultats seront présentés lors de la réunion annuelle de la Société de Neuro-Oncologie en 2024 à Houston, accompagnés d'autres présentations de pipeline.
Chimerix (NASDAQ: CMRX) hat aktualisierte Ergebnisse der Phase-2-Reaktionsbewertung für dordaviprone bei der Behandlung von rezidivierendem H3 K27M-mutierten diffusen Mittelhirngliomen bekannt gegeben. Mit den neuen RANO 2.0-Kriterien zeigte die Behandlung eine gesamt 28,0%ige Ansprechrate, mit einer medianen Zeit bis zur Antwort von 4,6 Monaten und einer mediani Dauer der Antwort von 10,4 Monaten. Das Unternehmen plant, diese aktualisierten Ergebnisse in seine bevorstehende Zulassung für ein neues Medikament bei den australischen Aufsichtsbehörden aufzunehmen. Die Ergebnisse werden auf dem Jahrestreffen der Society for Neuro-Oncology 2024 in Houston präsentiert, zusammen mit weiteren Pipeline-Präsentationen.
- 28.0% overall response rate in Phase 2 trial
- Median duration of response of 10.4 months
- Advancing towards New Drug Application in Australia
- Relatively long median time to response of 4.6 months
Insights
The updated Phase 2 trial results for dordaviprone (ONC201) show meaningful progress in treating H3 K27M-mutant diffuse midline glioma, a rare and aggressive brain tumor. The 28.0% overall response rate using the new RANO 2.0 criteria is particularly significant for this difficult-to-treat condition. The median duration of response of 10.4 months suggests durable treatment benefits.
The planned submission to Australian regulators marks a important regulatory milestone. The adoption of RANO 2.0 criteria strengthens the clinical validation by incorporating both enhancing and non-enhancing disease assessments, providing a more comprehensive evaluation of treatment efficacy. The multiple presentations at SNO, including safety data from the compassionate use program, demonstrate a robust clinical development program.
DURHAM, N.C., Nov. 11, 2024 (GLOBE NEWSWIRE) -- Chimerix (NASDAQ: CMRX), a biopharmaceutical company whose mission it is to develop medicines that meaningfully improve and extend the lives of patients facing deadly diseases, today announced upcoming presentations at the 2024 Society for Neuro-Oncology (SNO) Annual Meeting, which will be held in Houston, TX from November 21 – 24, 2024.
“We are excited to provide an updated assessment of objective response to dordaviprone previously reported in the blinded independent central review (BICR) cohort1 in recurrent H3 K27M-mutant diffuse midline glioma using Response Assessment in Neuro-Oncology (RANO) 2.02, the most recently established criteria for this disease. This analysis demonstrates an overall response rate of
“RANO 2.0 is a recently established response assessment criteria for gliomas that supersedes prior versions such as RANO-HGG and RANO-LGG. RANO 2.0 incorporates an integrated quantitative assessment of both enhancing and non-enhancing disease that were not adequately assessed by prior criteria. In addition, it includes minor responses, which in certain regions of the brain, such as midline structures, have disproportionate clinical benefit. This benefit often includes meaningful improvement in neurological symptoms and quality of life outcomes,” said Patrick Y. Wen, MD, Director of the Center for Neuro-Oncology at Dana-Farber Cancer Institute.
Details for the RANO 2.0 presentation as well as other pipeline presentations at SNO are as follows:
Title: Response by RANO 2.0 criteria in ONC201 (dordaviprone)-treated patients with recurrent H3 K27M-mutant diffuse midline glioma
Abstract Code: CTNI-54
Session Date and Time: Friday, November 22, 2024, from 7:30-9:30 PM
Location: The George R. Brown Convention Center, Hall B3
Title: 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
Session Date and Time: Friday, November 22, 2024, from 7:30-9:30 PM
Location: The George R. Brown Convention Center, Hall B3
Title: 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
Abstract Session: CNS Rare Tumors
Presentation Date and Time: Saturday, November 23, 2024, from 10:45am-12:15pm
Title: 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
Abstract Session: Pediatrics II
Presentation Date and Time: Saturday, November 23, 2024, from 10:45am-12:15pm
About Chimerix
Chimerix is a biopharmaceutical company with a mission to develop medicines that meaningfully improve and extend the lives of patients facing deadly diseases. The Company’s most advanced clinical-stage development program, ONC201, is in development for H3 K27M-mutant glioma.
Forward-Looking Statements
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, expectations regarding interim OS data from the ACTION study, plans for Provisional Registration and commercialization in Australia, expectations regarding assessment of responses. 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 ability to obtain and maintain accelerated approval, uncertainty on the response of regulators to including RANO 2.0 assessments in an application for marketing authorization; 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; risks related to the clinical development of our clinical candidates; 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.
CONTACT:
Will O’Connor
Stern Investor Relations
212-362-1200
- Arrillaga-Romany, et al, Journal of Clinical Oncology, Feb 2024
- Wen, et al, Journal of Clinical Oncology, Sept 2023
FAQ
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