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.
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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