On June 12, 2025 Galapagos NV (Euronext & NASDAQ: GLPG) reported that it 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 (EHA) (Free EHA Whitepaper) Congress (Press release, Galapagos, JUN 12, 2025, View Source [SID1234653875]). 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.

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"We are excited to share new promising safety and manufacturing data for GLPG5101 across multiple R/R NHL subtypes, reinforcing the potential of our novel rapid delivery approach," said Omotayo Fasan, M.D., Clinical Development Program Head at Galapagos. "By initiating lymphodepletion immediately after cell collection, we are able to infuse fresh product as soon as it becomes available, reducing patient attrition and potentially expanding access to CAR-T therapy. We observed a low 5% attrition rate, compared to rates of up to 30% reported in some clinical trials and real-world settings, and observed a manageable safety profile. These promising results suggest that rapid delivery of fresh, stem-like early memory cell therapies may offer meaningful clinical benefits for patients with R/R NHL."

"Decentralized cell therapy manufacturing is changing how we think about CAR-T eligibility. By enabling shorter vein-to-vein times and the use of fresh, early memory phenotype cells, this approach may allow for the inclusion of patients who would otherwise not be able to receive CAR-T therapy due to historically long manufacturing timelines," said Pim Mutsaers, M.D., Associate Professor, Department of Hematology, Erasmus MC Cancer Institute.

The new ATALANTA-1 data are summarized below:
The oral presentation at EHA (Free EHA Whitepaper) features new safety and longer follow-up data for GLPG5101 in 64 patients with R/R large B-cell lymphoma (DLBCL, n=17), mantle cell lymphoma (MCL, n=13), follicular lymphoma (FL, n=29), and marginal zone lymphoma (MZL, n=5) from the ongoing ATALANTA-1 Phase 1/2 study (data cut-off: October 14, 2024). 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 (95%) received an infusion of GLPG5101. Of those 61 patients:
95% (58 patients) received a fresh product
89% (54 patients) received it within 7 days post-leukapheresis
7% (4 patients) received it within 8-21 days
5% (3 patients) received a cryopreserved product
None of the patients who received a fresh product required cytotoxic bridging therapy.
GLPG5101 showed an encouraging 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 (5/61).
Durable CAR T-cell persistence was observed up to 21 months across tumor types, phases, and dose levels.
Phase 1
(n=24) Phase 2
(n=37) All patients
(n=61)
CRS, n (%) 11 (45.8) 15 (40.5) 26 (42.6)
Grade 1, n (%) 5 (20.8) 8 (21.6) 13 (21.3)
Grade 2, n (%) 5 (20.8) 7 (18.9) 12 (19.7)
Grade 3, n (%) 1 (4.2) 0 1 (1.6)
Time to onset, median (range), days 7.5 (2–20) 7.0 (1–11) 7.0 (1–20)
Duration, median (range), days 3.0 (1–17) 3.0 (1–9) 3.0 (1–17)
CRS toxicity management, n (%)
Dexamethasone 4 (16.7) 7 (18.9) 11 (18.0)
Tocilizumab 6 (25.0) 9 (24.3) 15 (24.6)
Methylprednisolone 1 (4.2) - 1 (1.6)
Vasopressin 1 (4.2) - 1 (1.6)
ICANS, n (%) 8 (33.3) 4 (10.8) 12 (19.7)
Grade 1 8 (33.3) 3 (8.1) 11 (18.0)
Grade 2 0 0 0
Grade 3 0 1 (2.7) 1 (1.6)
Time to onset, median (range), days 14.0 (3–30) 8.5 (2–12) 11.5 (2–30)
Duration, median (range), days 2.5 (1–47) 1.5 (1–3) 2.0 (1–47)
ICANS toxicity management, n (%)
Dexamethasone (ICANS) 2 (8.3) 4 (10.8) 6 (9.8)
Tocilizumab (ICANS) 1 (4.2) 2 (5.4) 3 (4.9)
Infections, Grade ≥3, n (%) 2 (8.3) 1 (2.7) 3 (4.9)
Hemophagocytic lymphohistiocytosis, Grade ≥3, n (%) 2 (8.3) 0 2 (3.3)
Prolonged cytopenias,a Grade ≥3, n/n available (%)
30 days after infusion 8/21 (38.1) 11/37 (29.7) 19/58 (32.8)
60 days after infusion 5/21 (23.8) 9/33 (27.3) 14/54 (25.9)
90 days after infusion 4/20 (20.0) 8/30 (26.7) 12/50 (24.0)
a Includes all events related to neutropenia, thrombocytopenia, anemia, and lymphopenia.
CRS, cytokine release syndrome; ICANS, immune effector cell-associated neurotoxicity syndrome.
Table 1: Adverse events of special interest

About GLPG5101 and ATALANTA-1 (EudraCT 2021-003272-13; NCT 06561425)
GLPG5101 is a second generation anti-CD19/4-1BB CAR-T product candidate, administered as a single fixed intravenous dose. The safety, efficacy and feasibility of decentralized manufactured GLPG5101 are currently being evaluated in the ATALANTA-1 Phase 1/2 study in eight1 hematological malignancies with high unmet need. The primary objective of the Phase 1 part of the study is to evaluate safety and to determine the recommended dose for the Phase 2 part of the study. Secondary objectives include assessment of efficacy and feasibility of decentralized 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. The ATALANTA-1 study is currently enrolling patients in the U.S. and Europe.