Benzinga -
- Mesoblast Limited (NASDAQ: MESO) announced top-line long-term survival results for remestemcel-L from its Phase 3 trial (GVHD-001) in children with steroid-refractory acute graft-versus-host disease (SR-aGVHD).
- The results showed durable survival through 4 years of follow-up.
- These new long-term survival data are a key component of the company's BLA resubmission to the FDA for remestemcel-L in treating children with SR-aGVHD.
- A four-year observational cohort survival study was performed on 51 evaluable children with SR-aGVHD.
- Overall survival in the remestemcel-L cohort was 63% at one year, 51% at two years, and 49% at four years, with a median survival of 2 to 3 years.
- In recently published studies of children or adults with SR-aGVHD who received the best available therapy (BAT (LON:BATS)) or the only FDA-approved agent for adults, ruxolitinib, one-year survival was 40-49%, and two-year survival was 25%-38%, with median survival between 6.5 months and 11.1 months.
- Mesoblast is working towards a potential U.S. approval for remestemcel-L and its first product launch in H1 CY2023.
- Mesoblast is also developing remestemcel-L for chronic lower back pain due to degenerative disc disease.
- It is working towards FDA clearance by year-end 2022 to commence the second Phase 3 trial.
- Price Action: MESO shares traded 2.15% higher at $3.32 on the last check Wednesday.