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August 20, 2012
The American Journal of Transplantation published a phase III study of RAD001 (everolimus) with reduced tacrolimus for the treatment of liver transplant. This randomized, open-label, multi-center study enrolled 719 de novo liver transplant patients. Following liver transplantation and a 30-day run-in period with tacrolimus and corticosteroids (with or without mycophenolate mofetil), subjects were randomized into one of three groups: RAD001 (C0 3-8ng/mL) plus reduced-exposure tacrolimus (C0 3-5ng/mL); RAD001 (C0 6-10ng/mL)with tacrolimus withdrawal at four months; or standard-exposure tacrolimus (C0 6-10ng/mL) only. All arms included corticosteroids for at least six months post-transplant. The study met the amended primary endpoint: the composite efficacy failure rate of tBPAR, graft loss or death. The composite efficacy failure rate in the RAD001 plus reduced-exposure tacrolimus group was lower compared to the control group at month 12 (6.7% versus 9.7%, respectively). Data showed non-inferiority (against the non-inferiority margin of 12%) with -3.0% [97.5 CI (-8.7%, 2.6%)] in favor of the RAD001 plus reduced-exposure tacrolimus group (p<0.001 for non-inferiority). RAD001 plus reduced-exposure tacrolimus also demonstrated fewer episodes of tBPAR between day 30 and month 12. The FDA has accepted the filing for RAD001 for the prevention of organ rejection in adult liver transplant patients, and a decision is expected by Q4 2012.