LCP-Tacro tacrolimus: Phase III data

The open-label, international Phase III Study 3001 trial in 326 stable kidney transplant patients showed that once-daily LCP-Tacro met the primary endpoint of non-inferiority to twice-daily Prograf tacrolimus on a composite of death, graft failure, biopsy-proven acute rejection or loss to follow-up at 12 months as measured by local biopsy reading (2.5% for both, 95% CI for the difference: -4.2%, 4.2%). LifeCycle said the pre-specified criterion for non-inferiority was an upper bound of the 95% CI of 9%. Specifically, there were 2 cases of biopsy-proven acute rejection and 2 deaths in patients receiving LCP-Tacro compared to 2 cases of biopsy-proven acute rejection, 1 death and 1 patient lost to follow-up for Prograf.

A secondary analysis of the composite primary endpoint as measured by central biopsy reading showed that LCP-Tacro led to a treatment-failure rate of 2.5% vs. 4.9% for Prograf. Additionally, the rate of biopsy-proven acute rejection was non-significantly lower for LCP-Tacro vs. Prograf (0.6% vs. 3.1%, p=0.214). Furthermore, the proportion of biopsied patients with acute rejection was lower for LCP-Tacro (n=21) as measured by both local and central biopsy readings vs. Prograf (n=10; 9.5% and 4.8%, respectively, vs. 20% and 50%). ...