Phase III Endpoint Setback For Takeda's Maribavir in 1L HSCT Setting
But Safety, Durable Response Benefits Seen
Executive Summary
Oral CMV drug did not meet primary non-inferiority endpoint in a comparative Phase III trial as a first-line therapy in stem cell transplant recipients, but demonstrated clinically meaningful and durable viremia clearance. Japanese firm discussing potential ways forward with regulators and impact on planned submission timelines currently unclear.