KEY TAKEAWAYS
- The study aimed to characterize the in vivo cellular expansion of Lisocabtagene maraleucel (liso-cel) in the pivotal study TRANSCEND NHL 001 (ClinicalTrials.gov identifier, NCT02631044).
- The study used two bioanalytical methods, quantitative polymerase chain reaction and flow cytometry, to assess the cellular kinetics of liso-cel and determine its association with efficacy and safety outcomes after adjusting for key baseline characteristics.
- The study revealed a repeat dosage of liso-cel, but in vivo, cellular growth was lower following repeat dosing than following the initial dose.
Lisocabtagene maraleucel (liso-cel) is a CD19-targeted, chimeric antigen receptor T-cell therapy used to treat adult patients with relapsed or refractory large B-cell lymphoma (LBCL) who have received two or more lines of systemic therapy. The in vivo expansion of liso-cel after a single dose has been extensively studied and characterized. In this article, researchers further examined the in vivo expansion of liso-cel in the pivotal TRANSCEND NHL 001 study (ClinicalTrials.gov identifier, NCT02631044) to evaluate the relationship between in vivo cellular expansion, efficacy and safety after adjusting for key baseline characteristics.
Two bioanalytical methods were used to assess cellular kinetics: quantitative polymerase chain reaction and flow cytometry. These methods showed a high degree of concordance for in vivo cellular expansion. Researchers used multivariable logistic regression analyses to demonstrate that a higher in vivo cellular increase of liso-cel was associated with a higher overall response. Patients with relapsed or refractory LBCL had a greater prevalence of cytokine release syndrome, total response rate, and neurological complications. The relationship between in vivo cellular expansion and efficacy was likely confounded by age and tumor burden (by the sum of the product of perpendicular diameters). The association became stronger after controlling for these factors. The study also evaluated repeat dosing of liso-cel, but the in vivo cellular expansion was lower after repeat dosing compared to the initial dose. The in vivo cellular kinetics of liso-cel and its relationship to outcomes in relapsed/refractory LBCL are thoroughly understood by this study.
Source: https://pubmed.ncbi.nlm.nih.gov/35156195/
Clinical Trial: https://clinicaltrials.gov/ct2/show/NCT02631044
Ogasawara K, Lymp J, Mack T, Dell’Aringa J, Huang CP, Smith J, Peiser L, Kostic A. In Vivo Cellular Expansion of Lisocabtagene Maraleucel and Association With Efficacy and Safety in Relapsed/Refractory Large B-Cell Lymphoma. Clin Pharmacol Ther. 2022 Jul;112(1):81-89. doi: 10.1002/cpt.2561. Epub 2022 Mar 20. PMID: 35156195; PMCID: PMC9311712.
