Novartis says 82 percent of leukaemia patients achieve complete remission with CAR-T cell therapy: study

Interim results from a Phase II study presented at the American Society of Hematology (ASH) annual meeting demonstrated that 82 percent of patients with relapsed/refractory B-cell acute lymphoblastic leukaemia (ALL) who received Novartis' experimental drug CTL019 achieved complete remission or complete remission with incomplete blood count recovery at three months post-treatment.

The company noted that for the 41 patients in the ELIANA trial with complete remission, no minimal residual disease was detected. Novartis added that the estimated relapse-free rate among responders was 60 percent six months after infusion with the CAR-T cell therapy.

The drugmaker indicated that "the results set the stage for filing CTL019 with the [FDA] in early 2017 for paediatric and young adult patients with r/r B-cell ALL." Novartis added that it also plans to seek approval from the European Medicines Agency later in 2017.

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The company noted 48 percent of patients in the study experienced grade 3 or 4 cytokine release syndrome, although no deaths occurred due to the complication. Novartis added that 15 percent of patients experienced grade 3 neurological and psychiatric events including encephalopathy and delirium.

"We have learned that the patients who come in with more leukaemia in their body have a much higher risk of getting sick," remarked lead investigator Stephan Grupp. The researcher explained that results did not show a big difference between patients whose leukaemia was refractory and those who had relapsed. "We do see a difference in toxicity," Grupp said, adding "refractory patients with high disease burden can get sicker temporarily on the way to remission."

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