Novartis Presents CTL019 Trial Results In Patients With R/r B-ALL

(RTTNews) - Novartis (NVS) said it presents results from first global registration trial of CTL019 in pediatric and young adult patients relapsed/refractory (r/r) pediatric and young adult patients with B-cell acute lymphoblastic leukemia (ALL).

ELIANA, the first global CAR T cell trial, will be the basis of a Biologics Licensing Application (BLA) to the FDA in early 2017.

Novartis said that the pivotal data from ELIANA is supported by CTL019 US multicenter trial (ENSIGN) as well as earlier single site trial in r/r pediatric and young adult patients with B-cell ALL

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 University of Pennsylvania (Penn) will present findings evaluating overall response to CTL019 therapy among r/r DLBCL patients with poor prognosis, the company specified.