An international phase-2 trial of a CAR-T cell therapy—to be published on-line Dec. 1 in the New England Journal of Medicine (and presented at the ASH annual meeting in San Diego)—found that 52 percent of patients responded favorably to the therapy; 40 percent had a complete response and 12 percent had a partial response. One year later, 65 percent percent of those patients were relapse-free, including 79 percent of complete responders. The median progression-free survival ‘has not been reached.’
Sixty-five percent of those patients—recruited from 27 sites in North America, Europe, Australia and Asia—were relapse free one year later, including 79 percent of the complete responders. The median progression-free survival for patients in this trial, known as JULIET; NCT02445248, “has not been reached,” the authors note.
This compares favorably with earlier studies based on chemotherapy. The retrospective SCHOLAR-1 study, published in 2017, found that only seven percent of patients with refractory DLBCL had a complete response. The median overall survival was a mere 6.2 months. “Outcomes were consistently poor across patient subgroups and study cohorts,” the SCHOLAR-1 authors noted.
More promising data from the JULIET trial “led to the Food and Drug Administration’s approval May 1, 2018 of tisagenlecleucel for treatment of DLBCL,” said study co-author Michael Bishop, MD, Professor of Medicine and Director of the Cellular Therapy Program at the University of Chicago Medicine. “Our current results are a promising sign of the potential for long-term benefit.”
Scott McIntyre, the first patient to receive CAR-T cell therapy for stage 3 DLBCL at the University of Chicago, was pleased to learn about the study results. He is now 30 months post treatment and has had no sign of recurrence. He still gets a transfusion of antibodies every two months to protect him from the risk of infection that comes with the loss of his normal B cells. But the South Bend, Indiana native quickly returned to his job and seldom misses a Notre Dame football game. He just returned from watching the undefeated team beat the University of Southern California.
Read more at: https://medicalxpress.com/news/2018-12-car-t-cell-therapy-outcomes-patients.html