Galapagos to present new data from ATALANTA-1 trial

Galapagos (GLPG) will present new data from the ongoing ATALANTA-1 Phase 1/2 study of its investigational CD19 CAR T-cell therapy, GLPG5101, in an oral presentation at the 30th European Hematology Association Congress. These data demonstrate encouraging safety outcomes, including low rates of high-grade toxicities, in R/R NHL. Additionally, with a rapid vein-to-vein time enabled by Galapagos’ decentralized manufacturing platform, 95% of patients treated in the study received fresh, non-cryopreserved GLPG5101, without the need for cytotoxic bridging therapy. The oral presentation at EHA features new safety and longer follow-up data for GLPG5101 in 64 patients with R/R large B-cell lymphoma, mantle cell lymphoma, follicular lymphoma and marginal zone lymphoma from the ongoing ATALANTA-1 Phase 1/2 study. The presentation also demonstrates the feasibility of Galapagos’ decentralized manufacturing platform to deliver fresh, stem-like early memory cell therapy with a median vein-to-vein time of seven days, robust in vivo expansion, and durable persistence. As of 14 October 2024, 64 patients underwent leukapheresis, of whom 63 received lymphodepleting chemotherapy and 61 received an infusion of GLPG5101. Of those 61 patients: 95% received a fresh product, 89% received it within seven days post-leukapheresis, 7% received it within 8-21 days and 5% received a cryopreserved product. None of the patients who received a fresh product required cytotoxic bridging therapy. GLPG5101 showed a safety profile in the context of robust CAR T-cell peak expansion and durable persistence, with the majority of Grade 3 treatment emergent adverse events being hematological. Cases of CRS and ICANS were few and predominantly low-grade with only a single Grade 3 report of each. Dose-limiting toxicities were found in 8% of patients. Durable CAR T-cell persistence was observed up to 21 months across tumor types, phases, and dose levels.