Posted by Michael Wonder on 04 Dec 2016
Novartis presents results from first global registration trial of CTL019 in paediatric and young adult patients with r/r B-ALL
4 December 2016 - ELIANA, the first global CAR T cell trial, will be the basis of a biologics licensing application to the FDA in early 2017.
Findings from a Novartis clinical trial (ELIANA) evaluating efficacy and safety of CTL019, an investigational chimeric antigen receptor T cell (CAR T) therapy, in relapsed/refractory (r/r) paediatric and young adult patients with B-cell acute lymphoblastic leukaemia (ALL) will be presented today during an oral session at the 58th American Society of Hematology (ASH) annual meeting (Abstract #221, December 3, 4:00-5:30 p.m.).
The global Phase II study found that 82% (41 of 50) of infused patients achieved complete remission or complete remission with incomplete blood count recovery at three months post CTL019 infusion. For all patients with complete remission, no minimal residual disease was detected. In addition, the estimated relapse-free rate among responders was 60% (95% CI: 36, 78) six months after infusion with CTL019.
The results set the stage for filing CTL019 with the US FDA in early 2017 for paediatric and young adult patients with r/r B-cell ALL.
