medwireNews: The 2-year follow-up results from the phase I/II ZUMA-1 trial of patients with refractory large B-cell lymphoma show that the chimeric antigen receptor (CAR) T-cell therapy axicabtagene ciloleucel remains efficacious and manageable in the long term.
Previously – at a median follow-up of 15.4 months – the investigators reported that a single infusion of the CD19-directed therapy led to an objective response rate (ORR) of 82% for the 108 trial participants, all of whom had either failed the most recent chemotherapy regimen or had disease progression within 12 months of autologous stem cell transplantation.
And now, they report an ORR of 83% for the 101 patients who could be assessed at a median of 27.1 months. The majority (58%) of the responses were complete, and the median duration of response was 11.1 months for all responding patients and unreached for those with a complete response.
Progression-free survival was a median of 5.9 months and the median overall survival duration had not been reached at data cutoff.
Lead author Frederick Locke (Moffitt Cancer Center, Tampa, Florida, USA) and team estimate that 50.5% of participants will be alive at the 24-month mark, which they say “represents a major improvement in clinical outcomes for these patients, for whom the expected median overall survival with conventional therapies is approximately 6 months, with a 2-year overall survival of approximately 20%.”
They continue: “The safety profile of axicabtagene ciloleucel 2 years after infusion was largely similar to that in previous reports.”
In all, 32% of participants experienced neurologic events of at least grade 3, while the rates of grade 3 or more severe infections, prolonged cytopenias (at ≥3 months), and cytokine release syndrome were 28%, 17%, and 11%, respectively. The researchers note, however, that axicabtagene ciloleucel treatment did not lead to any new incidences of either cytokine release syndrome or neurologic events during the extended follow-up.
There were four cases of grade 3 or 4 side effects since the previous analysis but none were attributed to the study drug by the investigators.
Noting that “[a] substantial proportion of patients with refractory large B-cell lymphoma treated with a single infusion of axicabtagene ciloleucel achieved durable responses lasting more than 2 years and needed no further consolidation therapy,” the ZUMA-1 researchers conclude that the CAR T-cell therapy “can offer durable remissions to patients who otherwise lack treatment options.”
But they emphasize the need for further research to replicate these overall survival findings and “to establish whether axicabtagene ciloleucel can improve quality of life in this setting.”
These results were simultaneously presented at the 60th American Society of Hematology Annual Meeting in San Diego, California, USA, and published in The Lancet Oncology.
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