Mesoblast Data Shows 15% Mortality vs 2% in Second-Line Ryoncil Use and Adult Trial Launch
Mesoblast reported 15% mortality before treatment completion in 53 steroid-refractory acute GVHD patients receiving Ryoncil as third-line under the Emergency IND program, compared with only 2% mortality in Phase 3 second-line use. The company plans to begin enrollment this quarter for a pivotal second-line adult trial to support FDA label extension.
1. High Survival Outcomes in SR-aGvHD Patients
Mesoblast reported that 15% of 53 steroid-refractory acute GVHD patients treated with Ryoncil as third-line therapy under the Emergency IND program died before completing treatment, compared with 2% mortality in Phase 3 second-line use, highlighting superior survival with earlier intervention.
2. Comparable Adult and Pediatric Efficacy
Adult patients in the Emergency IND program demonstrated day-100 survival rates at least on par with pediatric patients, indicating Ryoncil’s consistent efficacy across age groups and in both ruxolitinib-naive and resistant cases.
3. Planned Pivotal Second-Line Adult Trial
Enrollment is set to begin this quarter for a pivotal trial assessing early second-line use of Ryoncil in adults with severe steroid-refractory acute GVHD, aiming to expand FDA approval to the larger adult patient population.