Bristol-Myers Squibb publishes positive 7-year data for its Nulojix

US drug major Bristol-Myers Squibb (NYSE: BMY) announced that a followup of its Phase III BENEFIT trial showed Nulojix (belatacept) statistically significantly reduced death or transplant failure in kidney transplant patients.

Results from the seven-year, long-term followup from a prospective, randomized Phase III trial in kidney transplant patients showed a 43% relative risk reduction of death or transplant failure in Nulojix over those receiving a cyclosporine regimen. The data also showed a statistically-significant survival benefit of 52% relative risk reduction of death or graft loss at five years post-transplant. The safety profile of the Nulojix regimen was similar to that of cyclosporine.

In the study followup, the rates of serious adverse events were similar across treatment groups (69% among Nulojix patients and 76% among patients receiving the cyclosporine regimen). The incidence rates (calculated as per 100-person years) were also similar among both groups for fungal infections (6.7% and 7.6%, respectively), viral infections (14.2% and 15.7%, respectively) and malignancies (1.7% and 2.6%, respectively).