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CTL 019 studies in paediatric ALL- Novartis

Read time: 1 mins
Last updated:9th Dec 2014
Published:9th Dec 2014
Source: Pharmawand
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Findings from continued clinical studies of investigational chimeric antigen receptor (CAR) therapy, CTL019 from Novartis, demonstrate its potential role in the treatment of certain types of lymphocytic leukemia. In one long-term study of pediatric patients with acute lymphoblastic leukemia (ALL), results showed that 36 of 39 pediatric patients with relapsed/refractory (r/r) ALL, or 92%, experienced complete remissions (CR) with CTL019. These results, which will be presented in an oral session at the 56th American Society of Hematology (ASH) annual meeting in San Francisco, continue to increase scientific understanding of CTL019 (Abstract #380, December 8,).

Additional abstracts will be presented at ASH that evaluate the efficacy and safety of CTL019 in the treatment of B cell cancers including ALL, chronic lymphocytic leukemia (CLL) and B cell non-Hodgkin lymphoma (NHL).

Additional highlights of the pediatric r/r ALL study include findings that patients have ongoing CR. Median follow-up was 6 months. Sustained remissions were achieved up to one year or more with 6-month event-free survival of 70% and overall survival of 75%, in most cases without further therapy. The probability of six-month CTL019 persistence was 68%, which was accompanied by B cell aplasia, a pharmacodynamic marker of CTL019 persistence and function. Persistence of CTL019 cells detected by flow cytometry and/or qPCR, and accompanied by B cell aplasia, continued for up to 30 months after infusion in patients with ongoing responses.

All responding patients developed cytokine release syndrome (CRS) at peak T cell expansion. Treatment for CRS was required for hemodynamic or respiratory instability in 33% of patients and CRS was managed with an IL-6 receptor antagonist, together with corticosteroids in five patients. These events were delayed, and few patients experienced infusional toxicities, including infusion-associated fever.

See-Grupp, Stephan A. et al. (8 December 2014). T Cells Engineered with a Chimeric Antigen Receptor (CAR) Targeting CD19 (CTL019) Have Long Term Persistence and Induce Durable Remissions in Children with Relapsed, Refractory ALL [oral presentation]. 2014 American Society of Hematology Meeting and Exposition: Abstract 380/

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