OS Therapies says Phase 2b Herlystic trial posts 72.7% three-year survival vs. 45.8% historical control
OSTX•OS Therapies reported three-year overall survival of 72.7% in its Phase 2b Herlystic trial, compared with 45.8% for historical controls. The company is working on regulatory submissions and a confirmatory Phase 3 study.
1. Trial survival results
OS Therapies released final three-year survival results from its Phase 2b trial of Herlystic in resected pulmonary metastatic osteosarcoma. Three-year overall survival was 72.7%, compared with 45.8% among historical controls. The company said regulatory submissions are underway in the U.S., U.K., Europe and Australia, tied to starting a confirmatory Phase 3 study; the program could qualify it for a U.S. Priority Review Voucher, with the most recent sale cited at $220 million.
