Clinical Trial Success75% of OST-HER2 treated patients achieved 2-year overall survival compared to 40% for historical control.
Market OpportunityThe efficacy data was viewed as encouraging, with a significant statistical difference in overall survival compared to historical controls.
Regulatory SupportOST-HER2 holds FDA Orphan, Fast Track, and Rare Pediatric Disease designations, making it eligible for a priority review voucher if approved.