Galapagos disclosed that its CD19 CAR‑T therapy candidate GLPG5101 achieved a 100 % objective response rate and a 96 % complete response rate in a Phase 2 study of mantle cell lymphoma (MCL). The study enrolled 26 heavily pre‑treated patients; 25 received an infusion, 24 of whom received a fresh product and 23 were treated within seven days of leukapheresis. Only one patient (4 %) dropped out before infusion, and the median follow‑up of nine months showed that 83 % of patients maintained durable responses and progression‑free survival.
The data cut‑off for the study was September 2, 2025, and the results were presented at the 67th American Society of Hematology meeting. In addition to the high response rates, 90 % of MRD‑evaluable patients were MRD‑negative at complete response, and 7 of 9 MRD‑negative patients remained in complete response at the data cut‑off. The 7‑day vein‑to‑vein manufacturing time eliminated the need for bridging therapy and reduced patient dropout, underscoring Galapagos’ decentralized manufacturing advantage.
Despite the encouraging clinical data, Galapagos reiterated its intention to wind down its cell‑therapy business, a decision announced on October 21, 2025. CEO Henry Gosebruch explained that the company had received no viable proposals that met its financial and strategic criteria, and that allocating capital to other areas of unmet need would be a more attractive use of resources. The wind‑down follows a broader strategic shift in which Galapagos has moved from a dual‑entity split to a focus on pipeline building through strategic transactions.
The juxtaposition of strong clinical results with the decision to exit the cell‑therapy space highlights the financial and operational challenges that can accompany even promising therapies. While the rapid manufacturing platform and high response rates could attract a buyer or partnership, the company’s assessment of market viability and capital allocation suggests that the business case for continued internal development was not compelling enough to justify ongoing investment.
The announcement signals that Galapagos will concentrate its resources on developing novel therapeutics through external collaborations and acquisitions, potentially reshaping its portfolio and influencing future partnership opportunities in the oncology space.
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