Galapagos NV 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 (R/R NHL) at the annual European Hematology Association (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 (DLBCL), follicular lymphoma (FL), marginal zone lymphoma (MZL) and mantle cell lymphoma (MCL).

There was a higher proportion of early phenotypes of CD4+ and CD8+ CAR T cells (naive/stem cell memory and central memory 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. Key new data from the ongoing Phase 1/2 ATALANTA-1 study include: As of the data cut-off date of December 20, 2023, 34 patients (17 in Phase 1 and 17 in Phase 2) 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. 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 (objective response rate, ORR 87.5%), with 12 patients achieving a complete response (CR) (CR rate, CRR 75%).

In Phase 2, 14 of 15 efficacy-evaluable patients responded to treatment (ORR 93.3%), and all responders achieved a complete response (CRR 93.3%). 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 (ORR 78%), with 5 patients achieving a complete response (CRR 56%). In patients with FL or MZL, objective and complete responses were observed in 16 of 17 efficacy-evaluable patients (ORR and CRR 94%).

In patients with MCL, all 5 of 5 efficacy-evaluable patients responded to treatment (ORR and CRR 100%). 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. ATALANTA-1 is an ongoing Phase 1/2, open-label, multicenter study to evaluate the safety, efficacy and feasibility of decentralized manufactured GLPG5101, a CD19 CAR-T product candidate, in patients with relapsed/refractory non-Hodgkin lymphoma (R/R NHL). GLPG5101 is a second generation anti-CD19/4-1BB CAR-T product candidate, administered as a single fixed intravenous dose.

The primary objective of the Phase 1 part of the study is to evaluate the safety and preliminary efficacy to determine the recommended dose for the Phase 2 part of the study. Secondary objectives include assessment of efficacy and feasibility of near the point-of-care manufacturing of GLPG5101. The dose levels that were evaluated in Phase 1 are 50×106 (DL1), 110×106 (DL2) and 250×106 (DL3) CAR+ viable T cells.

The primary objective of the Phase 2 part of the study is to evaluate the objective response rate (ORR), while the secondary objectives include complete response rate (CRR), duration of response, progression free survival, overall survival, safety, pharmacokinetic profile, and the feasibility of decentralized manufacturing. Each enrolled patient will be followed for 24 months.