publication date: Feb. 2, 2018

Clinical Roundup Trial shows durable remissions with Kymriah in children, young adults with r/r ALL

Novartis has announced updated results from the pivotal ELIANA clinical trial of Kymriah (tisagenlecleucel), formerly CTL019, in relapsed or refractory (pediatric and young adult patients with B-cell acute lymphoblastic leukemia have been published in The New England Journal of Medicine. New data include longer-term follow-up and efficacy in 75 infused patients, analysis of expansion and persistence of Kymriah, and longer-term safety.

Kymriah became the first chimeric antigen receptor T cell therapy to receive regulatory approval in August 2017, when it was approved by FDA for the treatment of patients up to 25 years of age with B-cell precursor ALL that is refractory or in second or later relapse, based on previous results from the ELIANA study, which was conducted in collaboration with the University of Pennsylvania and Children’s Hospital of Philadelphia.

In the analysis of 75 infused patients with three or more months of follow-up, Kymriah demonstrated an overall remission rate of 81% (95% CI: 71% – 89%). Sixty percent of patients achieved complete remission and 21% of patients achieved CR with incomplete blood count recovery, with no minimal residual disease detected among all responding patients (95% [58/61] by day 28). Median follow-up was 13.1 months.

Among patients who achieved CR/CRi, median duration … Continue reading Trial shows durable remissions with Kymriah in children, young adults with r/r ALL

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