FDA Grants Fast Track Designation to Galinpepimut-S for Treatment of Myeloma
Posted: Monday, July 30, 2018
Recently, the U.S. Food and Drug Administration (FDA) granted Fast Track designation to galinpepimut-S for the treatment of multiple myeloma. Galinpepimut-S is a heteroclitic multivalent, multipeptide cancer immunotherapeutic agent composed of 4 peptides, addressing over 20 epitopes, and derived from the WT1 protein.
This Fast Track designation was made on the basis of the open-label phase II clinical trial results evaluating 19 patients with multiple myeloma who had high-risk cytogenetics at initial diagnosis and remained at least minimal residual disease–positive after a successful autologous stem cell transplant. Galinpepimut-S was administered to all patients participating in the study who achieved stable disease or better status after ASCT. Galinpepimut-S was evaluated as consolidation therapy to potentially stimulate a highly specific immune response against WT1 to prevent or delay myeloma progression.
Median progression-free survival of 23.6 months was reported in the high-risk disease setting, compared with historically inferior outcomes while on an immunomodulatory drug or proteasome inhibitor after ASCT maintenance. Median overall survival has not been reached to date.
