Kadmon reports Phase IIa data for chronic GvDH candidate

Kadmon Holdings Inc. (NYSE:KDMN) reported data from the Phase IIa KD025-208 trial evaluating KD025 to treat steroid-dependent or steroid-refractory chronic graft-versus-host disease (GvHD) in patients who have received an allogeneic bone marrow transplant (BMT) or a hematopoietic stem cell transplant (HSCT). Data were presented at the American Society of Hematology meeting in Atlanta in December.

Once-daily 200 mg KD025 led to an overall response rate (ORR) of 65% in 17 evaluable patients and twice-daily 200 mg led to an ORR of 63% in 16 evaluable patients. ORR was defined as the percentage of patients who met the 2014 NIH Consensus Conference overall response criteria. Kadmon said responses were observed across all affected organs, including complete responses in the upper and lower gastrointestinal tract, mouth, skin, joints, esophagus, eyes and liver. Additionally, 64% of patients across both cohorts were able to reduce their steroid dose and four patients completely discontinued steroids. Furthermore, 83% of patients were able to reduce their dose of tacrolimus. KD025 was well tolerated with no treatment-related serious adverse events reported...