Felzartamab Effective in Kidney Transplant Rejection

The Phase III  study will evaluate the efficacy and safety of the investigational drug felzartamab compared to placebo in adult kidney transplant recipients diagnosed with late antibody-mediated rejection (AMR). TRANSCEND is designed to enroll approximately 120 kidney transplant recipients with late AMR. TRANSCEND is a two-part, 52-week, double-blind, placebo-controlled, multicenter, randomized Phase III clinical trial (NCT06685757) to evaluate the efficacy and safety of felzartamab compared with placebo. In Part A, participants will be randomized to receive nine intravenous infusions of felzartamab or placebo over 6 months, and the efficacy and safety of felzartamab compared to placebo will be assessed at 24 weeks.

 The primary endpoint of TRANSCEND is the percentage of participants who achieve resolution by biopsy of AMR at 6 months. Key secondary endpoints include changes in microvascular inflammation (MVI) score and the percentage of patients achieving an MVI score of zero. MVI is a key histologic feature of AMR and higher MVI scores strongly correlate with reduced kidney allograft survival rates. By targeting CD38, felzartamab is designed to reduce pathogenic antibody producing plasma cells and NK cell activity, addressing key pathophysiologic drivers of MVI and AMR. In Part B, all participants will receive felzartamab for an additional open-label period of 6 months through 52 weeks in order to evaluate longer-term activity, safety and tolerability.

"Building upon the promising results from the Phase II study, which demonstrated felzartamab’s first-in-class potential, the launch of the TRANSCEND trial is a crucial milestone in the advancement of its clinical development,” said Travis Murdoch, Head of HI-Bio at Biogen. “Losing a kidney after receiving a long-awaited transplant is devastating for the patient and the donor. As we enroll this pivotal Phase III trial, we look forward to working in collaboration with medical and patient communities worldwide with the hope of bringing felzartamab forward as potentially the first meaningful treatment option, if approved, for people living with late AMR.”

"Antibody-mediated rejection remains a significant challenge in kidney transplantation, with limited safer and effective treatment options currently available. With the potential to be disease-modifying based on the encouraging results observed in the Phase II study, I believe felzartamab could be an important new therapeutic treatment option for patients with late AMR,” said  Dr. Suphamai Bunnapradist, principal investigator of the study and Professor of Clinical Medicine, Director of Research at Connie Frank Kidney Transplant Center, University of California, Los Angeles. "I am pleased to see Biogen enroll the first patient in the Phase III TRANSCEND study of felzartamab in AMR and look forward to the trial’s continued enrollment.”