Novartis pivotal CTL019 6-month follow-up data show durable remission rates in children, young adults with r/r B-cell ALL

Novartis International AG / Novartis pivotal CTL019 6-month follow-up data show durable remission rates in children, young adults with r/r B-cell ALL . Processed and transmitted by Nasdaq Corporate Solutions. The issuer is solely responsible for the content of this announcement.

• 83% of patients achieved complete remission (CR) or CR with incomplete blood count recovery within 3 months of treatment with CTL019; consistent with interim ELIANA data
   

Data evaluating 63 patients demonstrate relapse-free survival and probability of survival in a majority of patients at six months
 

Advances in CTL019 and ELIANA result from global CAR-T cell therapy collaboration with the University of Pennsylvania
 

CTL019 is manufactured using cryopreserved leukapheresis which, in the ELIANA trial, enabled the treatment of patients in 25 sites across four continents

Basel, June 23, 2017 - Novartis today announced updated results from the ELIANA clinical trial demonstrating CTL019 (tisagenlecleucel) remission rates are maintained at six months in relapsed/refractory (r/r) pediatric and young adult patients with B-cell acute lymphoblastic leukemia (ALL). These data from this pivotal trial of CTL019 show that 83% (52 of 63; 95% confidence interval [CI]: 71%-91%) of patients achieved complete remission (CR) or CR with incomplete blood count recovery within three months of infusion. No minimal residual disease (MRD) was detected among responding patients[1]. MRD, which measures the elimination of residual disease in the blood and bone marrow at the molecular level following treatment, is important because it may be an indicator of potential relapse[2]. Results from this study of CTL019 - an investigational chimeric antigen receptor T cell (CAR-T) therapy - will be presented at the European Hematology Association (EHA) Annual Meeting (Abstract #S476; Saturday, June 24, 4:00 PM CEST).

The ELIANA study also showed that the relapse-free probability was 75% (95% CI, 57%-87%; median duration of response not reached) at six months and 64% (95% CI, 42%-79%) at 12 months among responders. In addition, the probability of survival was 89% (95% CI, 77%-94%) at six months and 79% (95% CI, 63%-89%) at 12 months. The median time from infusion to data cutoff was 8.8 months[1].