Incyte Corporation announced disappointing results for a late-stage study of a promising drug.
The Phase 3 study that evaluated itacitinib in combination with corticosteroids in patients with treatment-naïve acute graft-versus-host disease did not meet endpoints. The disease occurs when donor bone marrow or stem cells attack the patient receiving them.
“The result of this study is disappointing. However, we remain committed to building on the success of the REACH program for ruxolitinib, which showed positive results in steroid refractory acute GVHD. Additionally, we will continue to study the role of JAK inhibition in chronic GVHD and in the prophylactic setting, as we seek to develop treatments for patients with this debilitating and often fatal disease,” said Steven Stein, M.D., chief medical officer, Incyte.
The primary endpoint is overall response rate (ORR) at Day 28, defined as the proportion of subjects demonstrating a complete response, very good partial response, or partial response. The key secondary endpoint is non-relapse mortality at month 6, defined as the proportion of subjects who died due to causes other than malignancy relapse.
Itacitinib was discovered at Incyte, and Incyte holds the global development and commercialization rights for itacitinib with the exception of China.