Yescarta against blood cancer
GM lymphocytes cured half of patients with large-cell B-lymphoma
Daria Spasskaya, N+1
Almost half of the patients considered hopeless with an aggressive form of large-cell B-lymphoma do not show signs of the disease 15 months after therapy with Yescarta. The researchers reported this in a report on clinical trials of the drug published in New England Journal of Medicine (Neelapu et al., Axicabtagene Ciloleucel CAR T-Cell Therapy in Refractory Large B-Cell Lymphoma).
The drug Yescarta (international name axicabtagen ciloleucel, axi-tsel) is a genetically modified T-lymphocytes with a chimeric antigen receptor (CAR-T) against the CD19 protein sitting on the surface of malignant B-lymphocytes. This year it was approved By the U.S. Food and Drug Administration for the treatment of several varieties of large-cell B-lymphoma in adult patients.
Researchers from 22 medical centers where the second phase of clinical trials of the drug was conducted published a trial report in which they reported that 42 percent of patients, after an average of 15 months after receiving therapy, are in remission, that is, they do not show signs of the disease. Some patients have been in remission for two years. The patients received therapy in the form of a one-time infusion of their own T cells into the blood, which had previously been selected and modified by embedding a construct with an anti-CD19 receptor into the genome.
In total, 111 patients with several types of aggressive large-cell B-lymphoma participated in the study. The age of the patients ranged from 23 to 76 years, and the average was 58 years. In all study participants, the disease resumed after one or two courses of treatment or bone marrow transplantation, and the prognosis was very poor.
After receiving therapy, the effect was observed in 82 percent of patients. Within three months, half of the patients completely got rid of malignant cells. Three patients died for reasons unrelated to therapy. A year after receiving the drug, 42 percent of patients were in complete remission.
Despite the encouraging results of treatment, CAR-T therapy is accompanied by severe side effects. Among them are immune suppression, neurological disorders and an acute inflammatory reaction associated with the simultaneous release of inflammatory mediators ("cytokine storm").
Due to the death of a patient due to the effects of drug administration, clinical trials of GM lymphocytes by Cellectis had to be discontinued.
In the Yescarta trials, the therapy caused side effects in almost all participants. 13 percent had an acute "cytokine storm", and 28 percent had temporary brain disorders. Suppression of immunity was observed in the majority of participants, anemia — in half. All patients were informed about the high risks associated with therapy before being included in the study, however, for patients it was almost the last chance for recovery.
The first drug based on CAR-T technology under the brand name Kumriah was approved in USA in August of this year for the treatment of acute lymphoblastic leukemia in patients under the age of 25 years. In trials of the drug, 83 percent of hopeless patients recovered within three months after therapy.
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