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CTL019 Highly Effective in Global Phase II ALL Study, FDA Submission Anticipated

Silas Inman @silasinman
Published Online: Sunday, Dec 04, 2016

HTTP://www.onclive.com/conference-coverage/ash-2016/ctl019-highly-effective-in-global-phase-ii-all-study-fda-submission-anticipated

The CAR T-cell therapy CTL019 demonstrated an 82% complete remission (CR) or CR with incomplete blood count recovery (CRi) rate for pediatric and young adult patients with relapsed/refractory B-cell acute lymphoblastic leukemia (ALL), according to findings from the global, phase II ELIANA study presented at the 2016 ASH Annual Meeting.

The phase II study enrolled patients at 25 centers in the United States, Europe, Asia, and Australia. In the first 50 patients enrolled, the CR rate was 68% and the CRi rate was 14%. All patients with a CR/CRi also tested negative for minimal residual disease (95% CI, 69-91; P <.0001). The 6-month overall survival rate was 89% (95% CI, 76-95) and the disease-free survival rate was 60%.

"There was high efficacy, with the primary endpoint met. All complete remissions were MRD-negative and durable," said lead investigator Stephan Grupp, MD, PhD, the Yetta Deitch Novotny Professor of Pediatrics at the Perelman School of Medicine at the University of Pennsylvania. "These global multicenter trial data build on earlier encouraging research conducted at a single trial site, and advance the case for CTL019 as a potential treatment for children and young adults with relapsed or refractory B-cell ALL.” - See more at: hxxp://www.onclive.com/conference-coverage/ash-2016/ctl019-highly-effective-in-global-phase-ii-all-study-fda-submission-anticipated#sthash.jCz3aKat.dpuf