Galapagos Reports 97% Complete Response Rate With GLPG5101 In Phase 1/2 ATALANTA-1 Trial For Relapsed/Refractory iNHL

Of the 34 patients enrolled in Cohort 3 of the ATALANTA-1 Phase 1/2 study, 32 received GLPG5101; 94% were infused with fresh CAR-T cells, and 93% were treated within seven days of manufacturing

GLPG5101 demonstrated promising efficacy with durable CAR-T cell persistence and a favorable safety profile, including a 97% complete response rate, 100% MRD negativity in evaluable patients, sustained CAR-T expansion up to 21 months, and low rates of severe CRS and ICANS, with no deaths reported

Mechelen, Belgium; June 18, 2025, 22:01 CET; Galapagos NV ((Euronext &, NASDAQ:GLPG) today presented 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 18th International Conference on Malignant Lymphoma (ICML). These data demonstrate high complete response (CR) and minimal residual disease (MRD) rates in heavily pretreated relapsed/refractory indolent non-Hodgkin lymphoma (R/R iNHL) patients (ATALANTA-1 Cohort 3). Additionally, with a rapid vein-to-vein time enabled by Galapagos' decentralized manufacturing platform, 93% of patients treated in the study received fresh, non-cryopreserved GLPG5101, without the need for cytotoxic bridging therapy.

"These safety, efficacy and manufacturing results represent a significant milestone for our GLPG5101 program in relapsed/refractory B-cell malignancies," said Omotayo Fasan, M.D., Clinical Development Program Head at Galapagos. "For patients who have often exhausted multiple lines of therapy and face limited treatment options, the favorable safety profile, high complete response rate, and consistent minimal residual disease negativity we observed are especially encouraging."