Safety and efficacy observed in this real-world study for patients with non-Hodgkin lymphoma similarly reflect findings from previous pivotal trials.
CAR-T cell therapy with Kymriah (tisagenlecleucel) safely and effectively treated children and young adults with relapsed/refractory acute lymphoblastic leukemia (ALL), in addition to adults with non-Hodgkin lymphoma (NHL), according to study findings published in Blood Advances.
“Although median follow-up is shorter in the [post-market requirement] study compared with the pivotal trials, there now exists substantial experience in the short-term follow-up safety and efficacy outcomes of tisagenlecleucel,” the study authors wrote.
Study authors assessed data from 511 patients from 73 centers from the post-market requirement study, of whom 410 had available follow-up data. Patients were either children or young adults with relapsed or refractory ALL (255 patients; median age at infusion, 13.2 years; 58.8% men) or adults with NHL (155 patients; median age at infusion, 65.4 years; 53.5% men), all of whom were treated with Kymriah.
Several outcomes were included in this study such as the incidence and severity of cytokine release syndrome, or the release of small proteins from immune cells into the blood which may result from CAR-T cell therapy. Duration of response was defined as the period between the date of first complete or partial remission to relapse, progression or death. Event-free survival in patients with ALL was the time between Kymriah infusion to all-cause death, treatment failure or relapse. Progression-free survival (PFS) in patients with NHL was defined as the time from Kymriah infusion to all-cause death or disease progression. Overall survival (OS) was considered the time between the Kymriah infusion and all-cause death. Follow-up was conducted for a median of 13.4 months in patients with ALL and 11.9 months in those with NHL.
The complete remission rate for patients with ALL was 85.5%. For 12 months, patients with ALL had a duration of response of 60.9%, event-free survival of 52.4% and OS of 77.2%.
In patients with NHL, the best overall response rate was 61.8%, which included an initial complete remission rate of 39.5%. Duration of response during a six-month period was 55.3%. In addition, patients with NHL had a PFS rate of 38.7% and an OS rate of 70.7%.
Cytokine release syndrome of grade 3 or more, which requires supportive care and Actemra (tocilizumab) either with or without corticosteroids, occurred in 11.6% of all patients. Neurotoxicity, or damage to the peripheral nervous system or the brain, was reported in 7.5% of all patients.
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