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A study involving the recently approved CD19-targeting chimeric antigen receptor (CAR) T-cell therapy shows that 42 percent of patients with aggressive large B-cell lymphoma remained in remission at 15 months following treatment with axi-cel.
The study also reported measurable responses in 82 percent of patients and complete responses in 54 percent, researchers said. Fifty-six percent were alive at 15 months following therapy, with some remaining cancer-free two years post-treatment, they said.
“With the FDA’s recent approval of this therapy, we believe this is a major advance in the treatment of patients with relapsed or refractory large B-cell lymphoma and is likely to save or prolong lives of many patients,” said Sattva Neelapu, a professor at The University of Texas in the US.
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The study, which began in April 2015, administered axi-cel to 108 patients who had failed prior chemotherapy and autologous stem cell transplantation. In some cases, the patients who had received chemotherapy were too far progressed to undergo stem cell transplantation and were placed on the trial following chemotherapy.
The patients’ T-cells were extracted through a process called leukapheresis and genetically re-engineered with CAR molecules that help T-cells attack cancer cells. The re-engineered T cells are infused back into the patient.
“This is the first FDA-approved gene therapy to treat adult lymphoma. Axi-cel consists of the patients’ own T cells that have been reprogrammed, and then re-infused to detect and destroy lymphoma,” said Frederick Locke from Moffitt Cancer Center in the US.
“Many patients’ lymphoma tumours melted away within a month. The long-term follow-up results of the ZUMA-1 trial show that axi-cel remissions can last years, and these are patients that did not respond to chemotherapy,” said Locke.