Galapagos presents new data from ATALANTA-1 study

Galapagos announced that it will present encouraging new data from the ongoing Phase 1/2 ATALANTA-1 study of CD19 CAR-T candidate, GLPG5101, in relapsed/refractory non-Hodgkin lymphoma, or R/R NHL, at the annual European Hematology Association, or EHA, 2024 Hybrid Congress. Galapagos’ product candidate GLPG5101 is produced using the company’s innovative, decentralized T-cell manufacturing platform. The oral presentation includes updated safety and efficacy data for GLPG5101 in patients with diffuse large B-cell lymphoma, or DLBCL, follicular lymphoma, or FL, marginal zone lymphoma, or MZL, and mantle cell lymphoma, or MCL. The presentation also includes durability and cellular kinetics data. At the data cut-off date of December 20, 2023, no unexpected safety findings were observed and treatment with GLPG5101 resulted in high complete response rates in all indications in this heavily pretreated patient population. GLPG5101 was administered as a fresh product in 94% of patients with a median vein-to-vein time of seven days, eliminating the need for bridging therapy. T-cell subsets were assessed in the apheresis starting material and final CAR-T product. There was a higher proportion of early phenotypes of CD4+ and CD8+ CAR T cells in the final product compared with starting material, indicating an increase of those populations during the manufacturing process. This demonstrates the feasibility of Galapagos’ decentralized manufacturing platform to deliver a high-quality CAR T-cell product to patients. As of the data cut-off date of December 20, 2023, 34 patients received GLPG5101 with a median vein-to-vein time of seven days. Overall, safety results were available for 33 patients and efficacy results were available for 31 patients. The data are summarized below: GLPG5101 showed an encouraging safety profile with most TEAEs1 of Grade 1 or 2; the majority of Grade = 3 events were hematological. Two cases of CRS2 Grade 3 were observed in Phase 1 and one case of ICANS3 Grade 3 was observed in Phase 2. In Phase 1, 14 of 16 efficacy-evaluable patients responded to treatment, with 12 patients achieving a complete response. In Phase 2, 14 of 15 efficacy-evaluable patients responded to treatment, and all responders achieved a complete response. High ORR and CRR were observed in the pooled Phase 1 and Phase 2 efficacy analysis set, split by indication: In patients with DLBCL, 7 of 9 efficacy-evaluable patients responded to treatment, with 5 patients achieving a complete response. In patients with FL or MZL, objective and complete responses were observed in 16 of 17 efficacy-evaluable patients. In patients with MCL, all 5 of 5 efficacy-evaluable patients responded to treatment. Durable responses were observed in the majority of responding patients: 71% of patients in Phase 1 had an ongoing response at data cut-off with median follow-up of 13.1 months. 100% of patients in Phase 2 had an ongoing response at data cut-off with median follow-up of 4.2 months. Strong and consistent in vivo CAR-T expansion levels and products consisting of early phenotype T cells were observed in all doses tested.