Galapagos Shares Positive Phase 1/2 Results for GLPG5101 in Relapsed/Refractory Non-Hodgkin Lymphoma

Galapagos NV recently shared promising new data from its Phase 1/2 ATALANTA-1 study, focusing on a novel CD19 CAR T-cell therapy, GLPG5101, for treating patients with relapsed or refractory non-Hodgkin lymphoma (R/R NHL). Presented at the 66th American Society of Hematology Annual Meeting, the results highlighted significant antitumor activity and a favorable safety profile across various NHL subtypes.

The ATALANTA-1 study primarily involves a heavily pretreated patient population, with 96% of participants receiving an infusion of fresh, stem-like, early memory CD19 CAR T-cells. This innovative approach achieved a median vein-to-vein time of just seven days, bypassing the need for cryopreservation and bridging therapy. Such rapid treatment availability is crucial for patients with aggressive cancers, where any delay can be detrimental.

Dr. Marie José Kersten, the principal investigator of ATALANTA-1 and a professor of Hematology at Amsterdam University Medical Center, emphasized the importance of minimizing vein-to-vein time in CAR-T therapy. She praised the latest data on GLPG5101 for its remarkable efficacy and safety, noting that the therapy's swift preparation time offers flexibility similar to off-the-shelf therapies.

Dr. Jeevan Shetty, Head of Clinical Development Oncology at Galapagos, echoed these sentiments. He underlined the importance of timely treatment for patients with fast-progressing cancers and reiterated the company's dedication to innovative cell therapy solutions. The data presented at the ASH meeting supports the potential of Galapagos’ decentralized cell therapy manufacturing platform, capable of delivering fresh, fit cells swiftly and effectively.

The study included participants with various NHL subtypes, such as mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), follicular lymphoma (FL), and diffuse large B-cell lymphoma (DLBCL). By the April 2024 data cut-off, 49 patients had received CD19 CAR T-cell therapy, with efficacy and safety data available for 45 and 42 patients, respectively.

Efficacy results were particularly impressive. In MCL patients, all eight evaluated patients responded to treatment, achieving 100% objective and complete response rates. For MZL and FL patients, 20 of 21 evaluable patients showed positive responses, with a 95% objective and complete response rate. Among DLBCL patients, 9 of 13 evaluable participants responded, with a 69% objective response rate and a 54% complete response rate. Notably, among the seven DLBCL patients treated with a higher dose, six responded, translating to an 86% objective response rate and a 71% complete response rate.

The safety profile of GLPG5101 was encouraging as well, with most Grade 3 or higher adverse events being hematological. Only one case of Grade 3 cytokine release syndrome (CRS) and one case of Grade 3 immune effector cell-associated neurotoxicity syndrome (ICANS) were reported.

In terms of minimal residual disease (MRD), 12 out of the 15 MRD-evaluable patients who achieved a complete response remained MRD-negative at the data cut-off, indicating sustained remission.

The ATALANTA-1 study is an open-label, multicenter trial designed to assess the safety, efficacy, and feasibility of the decentralized manufacturing of GLPG5101. This second-generation anti-CD19/4-1BB CAR-T product is given as a single intravenous dose. The primary goal in Phase 1 is to determine a recommended dose for Phase 2, while secondary goals include evaluating the feasibility of the decentralized manufacturing process.

Galapagos' decentralized cell therapy manufacturing platform stands out for its ability to deliver fresh, fit, early memory T-cells rapidly, within a median vein-to-vein time of seven days. This platform comprises the xCellit® workflow management and monitoring software, Lonza’s Cocoon® automated manufacturing system, and a proprietary quality control strategy, ensuring swift and efficient cell therapy production.

As a biotechnology company operating in Europe and the U.S., Galapagos is committed to transforming patient outcomes through innovative science, particularly in oncology and immunology. Their decentralized cell therapy platform exemplifies their drive to meet high unmet medical needs, offering groundbreaking solutions from the lab to the clinic.