1. GLPG5101 shows 100% response and 96% complete response in Phase 2. 2. Durable MCL treatment with low dropout rates and minimal toxicities reported. 3. Galapagos intends to wind down cell therapy operations despite GLPG5101's progress. 4. Ongoing consultations may affect future operations and clinical studies of GLPG5101. 5. Emphasis on potential acquisition of the cell therapy business remains.
FAQ
Why Neutral?
Despite promising data for GLPG5101, the wind-down of cell therapy poses uncertainty.
How important is it?
The article highlights significant clinical results but counters with potential business wind-down risks.
Why Long Term?
The overall impact will evolve based on regulatory outcomes and strategic decisions post-study.
Galapagos Unveils ATALANTA-1 Cell Therapy Findings for MCL at ASH 2025
On December 8, 2025, Galapagos NV (Euronext & NASDAQ: GLPG) presented promising new data from its ATALANTA-1 study at the 67th American Society of Hematology (ASH) Annual Meeting. The new findings detail the efficacy and safety of GLPG5101, a novel CAR T-cell therapy targeting high-risk mantle cell lymphoma (MCL) patients.
Key Findings from the ATALANTA-1 Study
The Phase 2 results demonstrated impressive outcomes for patients treated with GLPG5101. According to Dr. Marie José Kersten, Principal Investigator and Professor of Hematology at Amsterdam University Medical Center:
“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.”
Study Overview
Data presented included the following details:
- As of September 2, 2025, 26 heavily pretreated MCL patients underwent leukapheresis, with a 4% dropout rate resulting in 25 receiving GLPG5101.
- A total of 24 patients received fresh product, with 23 infused within seven days after apheresis.
- The objective response rate (ORR) was a remarkable 100% with a complete response rate (CRR) of 96%.
- Both duration of response (DOR) and progression-free survival (PFS) rates reached 83% at a median follow-up of nine months.
- Among the minimal residual disease (MRD)-evaluable patients, 90% achieved MRD negativity at complete response, with 7 of 9 remaining in complete response by the data cut-off.
Safety Profile
GLPG5101 exhibited a favorable safety profile, with the most common adverse events being hematologic and no occurrences of grade ≥3 cytokine release syndrome (CRS). Only one instance of grade ≥3 immune effector cell-associated neurotoxicity syndrome (ICANS) was reported.
Future of Galapagos’ Cell Therapy Business
Despite the promising data for GLPG5101, Galapagos announced on October 21, 2025, its intention to wind down cell therapy activities. This decision follows a thorough strategic evaluation and is contingent upon completing consultations with works councils in Belgium and the Netherlands.
Galapagos remains open to viable acquisition proposals for its cell therapy business during this winding down phase.
About GLPG5101 and the ATALANTA-1 Study
GLPG5101 is a second-generation anti-CD19/4-1BB CAR T-cell therapy administered as a single fixed intravenous dose. The ATALANTA-1 study aims to evaluate its safety, efficacy, and the feasibility of decentralized manufacturing in patients with hematological malignancies. This ongoing trial is currently enrolling participants in the U.S. and Europe.
Contact Information
For more information, individuals can reach out to:
- Investor Relations: Glenn Schulman, +1 412 522 6239, ir@glpg.com
- Corporate Communications: Marieke Vermeersch, +32 479 490 603, media@glpg.com
Forward-Looking Statements
This article includes certain forward-looking statements as defined under the Private Securities Litigation Reform Act of 1995. These statements involve risks and uncertainties that could cause actual results to differ from expectations. Investors are encouraged to review Galapagos' filings with the U.S. Securities and Exchange Commission for more detailed information about these risks.