Shots:
- SynOx has reported the global P-III (TANGENT) trial data assessing emactuzumab (1000 mg Q2W × 5 doses over 8wks.) vs PBO in TGCT for 6mos., followed by 18mos. follow-up with option for open-label emactuzumab upon disease progression
- Trial met 1 & 2EPs with high significance, improving ORR (RECIST v1.1) & Tumor Volume Score, along with meaningful gains in PROMIS-PF, physical function, pain, range of motion, & stiffness; the short-course regimen showed sustained, durable clinical benefits
- TANGENT data to be presented at a medical meeting & simultaneously published in a journal, while SynOx plans to submit a BLA to the US FDA in H2’26, followed by an EU MAA for emactuzumab in TGCT
Ref: Globenewswire | Image: SynOx | Press Release
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