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The investigational CD19-directed CAR T-cell therapy GLPG5101 was associated with high response rates and a favorable safety profile in patients with relapsed or refractory non-Hodgkin lymphoma. The remarkable 7-day vein-to-vein time is a major asset of this upcoming treatment.
The phase 1/2 ATALANTA-1 trial (CTIS 2022-502661-23-00) included patients with relapsed or refractory non-Hodgkin lymphoma to expose them to the fresh, stem-like, early memory phenotype, CD19-directed CAR T-cell therapy GLPG51011. “The therapy was manufactured using a decentralized platform, enabling a 7-day vein-to-vein time,” said Marie José Kersten, MD, PhD, from Amsterdam University Medical Center, in the Netherlands. The combined safety and efficacy population of the phase 1 and 2 studies comprised 45 participants.
Neutropenia of grade 3 or higher was a prevalent side effect (60–95%) in the study. Other grade 3 or 4 hematologic events occurred in 10–40% of the participants. Dr. Kersten mentioned that there was only one case of grade 3 cytokine release syndrome and no cases of grade 3 immune effector cell-associated neurotoxicity syndrome. “All in all, I think the safety profile was mild,” she summarized.
After a median follow-up of 3.3–4.4 months, the complete response (CR) rate was 100% in participants with mantle cell lymphoma (n=8), 95% in participants with follicular lymphoma or marginal zone lymphoma (n=21), and 54% in participants with diffuse large B-cell lymphoma (n=13).
“The preliminary results of the ATALANTA-1 study showed that GLPG5101 is associated with high response rates in patients with non-Hodgkin lymphoma and that this investigational CAR T-cell therapy has a manageable safety profile,” concluded Dr. Kersten. “The FDA has granted ‘Investigational New Drug’ clearance for the ATALANTA-1 study in the US.”
Medical writing support was provided by Robert van den Heuvel.
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