- Day One Biopharmaceuticals DAWN announced new data from the Phase 2 FIREFLY-1 trial of tovorafenib (DAY101).
- These data were shared at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting.
- The overall response rate (ORR) of 67% and clinical benefit rate (CBR) of 93% were observed in 69 heavily pretreated RANO-HGG evaluable patients.
- Related: Day One Biopharmaceuticals Shares Jump As Pediatric Brain Cancer Candidate Shows Encouraging Responses.
- Among 77 treated patients, the median duration of tovorafenib treatment was 10.8 months, with 74% (n=57) of patients on treatment at the time of data cutoff.
- Based on the 136 patients treated in Arm 1 and Arm 2 of FIREFLY-1, safety data indicated monotherapy tovorafenib to be generally well-tolerated.
- The vast majority of adverse events were Grade 1 or Grade 2, with the most common side effects being change in hair color (71%), fatigue (50%), vomiting (43%), maculopapular rash (41%), and headache (39%).
- In addition, the company said it initiated a rolling New Drug Application (NDA) to the FDA for tovorafenib as a monotherapy in relapsed or progressive pediatric low-grade glioma (pLGG).
- The company anticipates that the rolling NDA submission of tovorafenib will be complete in October 2023 following the submission of an amended clinical study report (CSR) that will include safety and efficacy data from a planned June 2023 data cutoff.
- Price Action: DAWN shares are up 23.20% at $16.75 during the premarket session on the last check Monday.
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Comments
Loading...
Benzinga simplifies the market for smarter investing
Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.
Join Now: Free!
Already a member?Sign in
