With early data in pediatric brain cancer, Day One preps larger first-line trial

With initial data showing that its lead molecule led to responses in heavily pretreated pediatric glioma patients, Day One is already moving ahead to a larger study of the pan-RAF inhibitor in newly diagnosed patients.

Shares of Day One Biopharmaceuticals Inc. (NASDAQ:DAWN) more than doubled on Monday after the company reported that tovorafenib (DAY101) led to a 64% objective response rate among 22 evaluable patients in the pivotal Phase II FIREFLY-1 trial, including 13 confirmed partial responses and an unconfirmed partial response. The study is evaluating the oral, selective RAF kinase inhibitor in patients with relapsed pediatric low-grade glioma (pLGG)...