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Caroline Hroncich was associate editor for Pharmaceutical Technology, Pharmaceutical Technology Europe, and BioPharm International from 2015 to 2017.
At the American Society of Hematology Annual Meeting, Novartis and Kite Pharma both released results from early-phase clinical trials with CAR-T therapies.
At the American Society of Hematology Annual Meeting held from Dec. 3–6, 2016 in San Diego, CA, Novartis and Kite Pharma presented results from clinical trials involving the company’s individual chimeric antigen receptor T cell (CAR-T) therapies. While there are currently no approved CAR-T therapies, the treatment has drawn significant attention from investors and biopharma companies. CAR-T works by isolating a patient’s T-cells, which are then genetically engineered to detect and attack tumor cells.
Novartis released results from its Phase II trial ELIANA, which tested the safety and efficacy of CTL019 in pediatric patients with relapsed/refractory B-cell acute lymphoblastic leukemia. The trial showed an 82% complete remission rate in patients at three months’ post infusion. The company also said the estimated relapse-free rate among responding patients was 60%, six months after infusion. Nearly half (48%) of patients experienced grade 3 or 4 cytokine release syndrome (CRS). CRS is a known complication of CAR-T therapy and is caused by the release of large numbers of cytokines. Novartis said no patients died from CRS, although it can be fatal if left untreated.
Kite Pharma’s ZUMA-I trial of axicabtagene ciloleucel (KTE-C19) saw 79% objective response rate and a complete response rate of 52% in patients with aggressive non-Hodgkin Lymphoma less than or equal to three months after infusion. Kite also said there were three deaths during treatment related to adverse events. Primary analysis of the trial will include a minimum of six-month follow up, the company said in a press release.
Both Novartis and Kite said they plan to apply for FDA approval of their CAR-T treatments in early 2017. Novartis said it would file for FDA approval in early 2017, and with EMA later in the year. Kite said it would seek regulatory approval for its therapy in the first quarter of 2017.