Mechelen, Belgium – Galapagos NV (Euronext & NASDAQ: GLPG) announced new and updated Phase 2 data from the ongoing ATALANTA-1 study with its CD19 CAR T-cell therapy candidate, GLPG5101, during an oral presentation (#662) at the 67th American Society of Hematology (ASH) Annual Meeting.
“The new and updated results from the Phase 2 ATALANTA-1 study demonstrate that GLPG5101 offers timely treatment with low rates of high-grade toxicities and durable responses for patients with relapsed or refractory MCL,” said Marie José Kersten, MD, ATALANTA-1 Principal Investigator and Professor of Hematology at Amsterdam University Medical Center. “The short 7-day vein-to-vein time enabled a low dropout rate and eliminated the need for bridging therapy, allowing more patients to receive treatment who otherwise might not have been able to access CAR T-cell therapy.”
Summary of ATALANTA-1 data from the MCL cohort (pooled data across two dose levels):
As of September 2, 2025 (data cut-off date), 26 heavily pretreated MCL patients had undergone leukapheresis and 25 had received an infusion of GLPG5101 (4% dropout rate). Of these, 24 patients received a fresh product, with 23 infused within seven days after apheresis.
- Among infused patients (N=24), the objective response rate (ORR) was 100%, with a complete response rate (CRR) of 96%. Duration of response (DOR) and progression-free survival (PFS) rates were both 83% at a median follow-up of 9 months.
- 9 of 10 (90%) of minimal residual disease (MRD)-evaluable patients were MRD-negative at CR and 7 of 9 MRD-negative patients remained in CR at the time of the data cut-off.
- GLPG5101 showed an encouraging safety profile (N=24). The most common Grade ≥ 3 treatment-emergent adverse events were hematologic. No Grade ≥ 3 CRS was observed, and only one case of Grade ≥ 3 ICANS occurred.
- GLPG5101 demonstrated robust in vivo CAR T-cell expansion and long-term persistence with an enrichment of early memory phenotypes.
Intention to wind down Galapagos’ cell therapy activities
As announced on October 21, 2025, and following a comprehensive strategic and evaluation and sales process, Galapagos remains focused on the intention to wind down the cell therapy activities. This intention is subject to the conclusion of consultations with works councils in Belgium and the Netherlands, during which Galapagos will continue to operate the business and conduct ongoing clinical studies. Galapagos would still consider any viable proposal to acquire all, or part of the cell therapy business, should such a proposal emerge during the wind down process.
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 eight 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.
For further information, contact Galapagos:
Investor Relations
Glenn Schulman
+1 412 522 6239
Corporate Communications
Marieke Vermeersch
+32 479 490 603
Visit us at www.glpg.com or follow us on LinkedIn or X.