- Day One Biopharmaceuticals DAWN shares are surging on initial data from the first 22 evaluable patients in the Phase 2 FIREFLY-1 trial for tovorafenib (DAY101) in relapsed or progressive pediatric low-grade glioma (pLGG), the most common brain tumor diagnosed in children.
- Initial data demonstrated an overall response rate (ORR) of 64% and a clinical benefit rate (CBR) of 91%.
- The data included 14 partial responses and six patients with stable disease.
- All patients with stable disease (n=6) were noted to have tumor shrinkage, ranging between 19% and 43%
- The median-time-to-response was 2.8 months. All patients who responded remain on therapy (n=14), and no patients have discontinued treatment due to adverse events.
- Initial safety data, based on the first 25 patients, indicated monotherapy tovorafenib to be generally well-tolerated.
- Day One will release topline results for the entire FIREFLY-1 pivotal study population in Q1 of 2023. If the data are supportive, the company expects to submit an FDA marketing application in 1H 2023.
- Based on these initial FIREFLY-1 data, Day One plans to expand the development of tovorafenib as front-line therapy for patients newly diagnosed with pLGG.
- The Phase 3 trial will enroll approximately 400 patients.
- Price Action: DAWN shares are up 85.65% at $12.29 during the premarket session on the last check Monday.
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