OS Therapies Posts 67% Two-Year Survival in Osteosarcoma Study

OS Therapies said updated interim results from its Phase 2b study of OST-HER2 in fully resected, pulmonary metastatic osteosarcoma showed a 66.6% two-year overall survival rate among 27 treated patients, compared with 40% in a historical control group (p = 0.0046). On the back of the data, the U.S. Food and Drug Administration has assigned the candidate a Biologics Licensing Application number ahead of an end-of-Phase-2 meeting scheduled for 27 August, positioning the company to pursue an accelerated approval filing in 2025. Separately, OS Therapies said it received positive scientific advice from the U.K. Medicines and Healthcare products Regulatory Agency and has applied for the regulator’s Innovative Licensing and Access Pathway, which could shorten review times in Britain. In another oncology update, SELLAS Life Sciences reported that an independent data monitoring committee recommended its Phase 3 REGAL trial of the cancer vaccine galinpepimut-S in acute myeloid leukemia continue without changes after a scheduled review, allowing the study to advance toward its next interim analysis.