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Higher CAR T Doses May Improve Survival Outcomes

October 27, 2022

November 2022

Higher doses of tisagenlecleucel, a chimeric antigen receptor (CAR) T-cell therapy, were associated with improved outcomes for younger patients with leukemia, according to a recent study.

Tisagenlecleucel is currently approved by the U.S. Food and Drug Administration to treat relapsed or refractory B-cell acute lymphoblastic leukemia (ALL) in patients up to age 26. In this indication, patients are treated with one dose of tisagenlecleucel, though the dose range varies widely.

Any amount of CAR T cells within the approved range is considered an acceptable dose, but if more than the minimum number of cells are available within the approved range, doctors can decide whether to use a higher or lower amount. Clinical trials for tisagenlecleucel provided guidance on dosing that led to the therapy’s approval, but real-world data are useful to fine-tune dosing and inform decision making when there are multiple options available.

Researchers used retrospective data from the Pediatric Real World CAR Consortium (PRWCC) member institutions to observe the effect of different doses on survival outcomes. Results were published in Blood Advances and showed that among patients who received CAR T-cell therapy, 86% of those who received the highest dose were alive one year after treatment versus 59% of those who received the lowest dose.

In addition to improved survival outcomes, higher doses of tisagenlecleucel were not associated with safety concerns or increased toxicity.

“In the past, we did not have data to guide clinical decisions around commercial CAR T-cell dosing and didn’t know if higher doses would affect toxicity and compromise outcomes or support enhanced anti-leukemia effect,” said Liora Schultz, MD, pediatric oncologist at Stanford Children’s Health Lucile Packard Children’s Hospital and the study’s lead author. She added the present data have direct clinical applicability and support the use of higher dosing within the approved range.

Sources: ASH, August 8, 2022; Blood Advances, August 8, 2022.

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