Over a year after the FDA approved the clinical trials for Kymriah, the phase 2 study of the CAR-T cell therapy showed some promising results.
In a paper published in the New England Journal of Medicine and presented at the ASH annual meeting in San Diego, the international team of researchers in charge of the study reported the clinical trial results of their CAR-T cell therapy trial.
According to the researchers, 52 percent of the patients who participated in the study responded positively to the treatment. Of those, 40 percent responded completely while the remaining 12 percent had a partial response to the therapy.
About 65 percent of the patients recruited by the team from 27 regions across North America, Europe, Australia, and Asia are reportedly relapse-free after a year. The figure also includes 79 percent of patients who were complete responders.
The JULIET Trial and CAR-T Cell Therapy
The researchers further reported that they had not yet reached the median progression-free survival for patients in the clinical trial they called JULIET; NCT02445248. However, the findings are still favorable as compared to earlier studies based on chemotherapy treatment.
“Our current results are a promising sign of the potential for long-term benefit,” Michael Bishop, co-author of the study, Professor of Medicine, and Director of the Cellular Therapy Program at the University of Chicago Medicine, said.
Bishop claimed that the positive data produced by the JULIET trial eventually led the Food and Drug Administration to approve the clinical trial of the tisagenlecleucel treatment for DLBCL.
During the course of the trial, the researchers took blood from the participants, extracted the T-Cells, and then returned everything else. The care team then shipped the T-Cells to the Morris Plains facility of Novartis, the Switzerland-based pharmaceutical who owns the rights to the treatment, in New Jersey.
In the facility, the scientists modified the T-lymphocytes to let them find and eliminate the B-Cells that cause the disease. Unfortunately, while the treatment was deemed promising, it can allegedly have severe but self-limited side effects. Some of the reported effects include acquiring cytokine release syndrome which causes fever and fluctuation in blood pressure.
“Overall, this is extremely exciting. Relapses after 12 months are infrequent. Our first patient, treated in May 2016, has been back at work for two and a half years. This trial demonstrates that CAR-T cell therapy can provide a high rate of durable responses,” Bishop went on to say.