Scott R. Solomon, MD, medical director of the Blood and Marrow Transplant Matched Unrelated Donor Program and the Stem Cell Processing Laboratory, and a physician in the Leukemia Program, at Northside Hospital, discusses the adverse events (AEs) and pharmacokinetics of lisocabtagene maraleucel (liso-cel; Breyanzi) in 12 patients with relapsed/refractory large B-cell non-Hodgkin lymphoma (NHL) who had previously received anti-CD19 therapy.
The investigators expected some differences in efficacy from the overall population of the TRANSCEND-NHL-001 trial (NCT02631044) but did not expect increase in AEs. Whether or not there would be an increase in AEs is an important question to ask, according to Solomon. In these 12 patients, there were similar toxicities to the overall population. Cytokine release syndrome and neurological events were the most important AEs in this study. There were no grade 3, 4, or 5 events for these toxicities, only grade 1 and 2. The safety profile was similar in the patients who had received anti-CD19 therapy and the overall study population.
The pharmacokinetics of the cellular expansion, or how rapidly the chimeric antigen receptor (CAR) T cells expanded and how long the CAR T cells persisted in vivo, was also investigated for the 12 patients and overall group. Solomon says there was no difference in the expansion kinetics or persistence of these cells, reinforcing what was seen with the efficacy data for this trial.