Novartis gives update on CAR therapy

Novartis and the University of Pennsylvania have issued a clinical update of their cell therapy for paediatric patients with acute lymphoblastic leukaemia (ALL) showing that 36 out of 39 patients, or 92% of trial participants, experienced a complete remission of their disease.

Novartis and the University of Pennsylvania have issued a clinical update of their cell therapy for paediatric patients with acute lymphoblastic leukaemia (ALL) showing that 36 out of 39 patients, or 92% of trial participants, experienced a complete remission of their disease.

Additionally, sustained remissions were achieved for up to one year or more with a six-month event-free survival of 70% and overall survival of 75%, in most cases without further therapy. Novartis issued data from the study of CTL019, a chimeric antigen receptor (CAR) therapy, on 6 December 2014. Additional data from the Phase 2 trial will be presented on 8 December at the annual meeting of the American Society of Hematology in San Francisco, California.

Developed by scientists at the University of Pennsylvania, the therapy involves genetically modifying T cells extracted from patients with cancer and re-injecting them into the same patients with the goal of destroying the disease. The T cells have been programmed to hunt cancer cells that express the CD19 protein.

All of the patients in the study have relapsed/refractory ALL. “We’re seeing pediatric patients who have not responded to any other therapy achieve complete remission as a result of treatment with CTL019”, Stephan Grupp, the lead investigator, said in a prepared statement.

All of the responding patients developed cytokine release syndrome at peak T cell expansion. Treatment was required for 33% of patients and this was managed with an IL-6 receptor antagonist, together with corticosteroids in five patients, the company said.

According to clinicaltrials.gov, the Phase 2 study is expected to complete in August 2017.

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