Novartis posts 82% remission rate in CAR T paediatric study
pharmafile | December 5, 2016 | News story | Research and Development, Sales and Marketing | CAR T, CAR-T, Novartis, leukaemia, paediatric
Novartis has released the results of its global, paediatric study of the treatment of leukaemia in children and young adults with CAR T therapy. The study found that the 82% of patients (41 patients out of 50) experienced complete remission, with 60% of patients relapse-free after six months of the treatment.
CAR T therapy is a treatment that genetically alters a patient’s T-cells, which are a type of white blood cell. Once altered, the modified cells are infused into the patient’s bloodstream, which help the patient’s immune system to identify and kill cancer cells.
It’s a promising new area for treatment, especially so given the particularly aggressive type of leukaemia that Novartis had sought to treat. The children and young adults involved in the test were suffering from relapsed or refractory B-cell lymphoblastic leukaemia. The patients involved were enrolled on a global scale, in 25 centres across the US, EU, Canada, Australia and Japan.
This type of treatment has the potential to lead to cytokine release syndrome (CRS), whereby toxicity is generated by the introduction of the engineered cells into the patient’s body. In its study, Novartis found that only 15% of patients experienced grade 3 neurological and psychiatric events, including encephalopathy and delirium, with no grade 4 events reported and no deaths resulting from the treatment.
“This first-of-its-kind trial represents exciting progress toward our goal of helping children and young adults with relapsed or refractory B-cell ALL, a patient population with an urgent need for new treatment options,” said Bruno Strigini, CEO, Novartis Oncology. “We are committed to advancing CTL019 and look forward to working closely with the FDA and EMA in the coming months.”
Novartis announced that it will file for approval with the FDA early next year, and will follow that up by filing with the EMA subsequently.
Ben Hargreaves
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