Takeda Reports P-III Trial (AURORA) Results of Maribavir for Cytomegalovirus Infection in Hematopoietic Stem Cell Transplant Patients
Shots:
- The P-III trial (AURORA) evaluating maribavir vs valganciclovir in 553 HSCT recipients with CMV inf.
- The results showed that patients achieved CMV clearance (69.6% vs 77.4%) @8wk. but failed to meet its 1EPs of non-inferiority based on the prespecified margin of 7%, At 16wk., 52.7% vs 48.5% achieved maintenance effect of viremia clearance & symptom control from 8wk. The sustained maintenance effect was reported during post-treatment evaluations @12wk. (59.3% vs 57.3%) & at 20wk. (43.2% vs. 42.3%), respectively
- The therapy showed a favorable safety profile, treatment-emergent neutropenia (63.5% vs 21.2%), and a high rate of premature treatment discontinuation (17.5% vs 4%). The results will be submitted for publication in a peer-reviewed journal
Ref: Businesswire | Image: Takeda
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