European Hematology Association: Global Trial of the Efficacy and Safety of CTL019 in Adult Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma: An Interim Analysis of the JULIET Study

MADRID, June 24, 2017 /PRNewswire/ --

CTL019 consists of genetically engineered autologous T cells expressing a chimeric antigen receptor (CAR). Results from a prior single-center phase 2 study at the University of Pennsylvania showed that a single infusion of CTL019 could produce durable remissions in adult patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL). The JULIET trial is a Novartis-sponsored, single-arm, open-label, multicenter, global phase 2 trial of CTL019 in adult patients with r/r DLBCL. Patients in the JULIET trial had relapse or progression after at least two prior lines of therapy and were not candidates for stem cell transplant. Cryopreserved leukapheresis products were used to manufacture CAR T cells, which were provided to patients at 27 centers in 10 countries on four continents. The primary endpoint was centrally reviewed best overall response rate (ORR: complete response [CR] + partial response [PR]). 85 patients received a single dose of CTL019. Among 51 patients with ≥3 months follow-up or earlier discontinuation, best ORR was 59% (43% achieved CR and 16% achieved PR). The JULIET trial met its primary endpoint. All patients in CR at three months remained in CR at data cutoff. All-grade and grade 3 or 4 cytokine release syndrome (CRS) occurred in 57% and 26% of treated patients, respectively; no CRS-related deaths were reported. 21% and 13% of patients had all-grade and grade 3 or 4 neurologic events, respectively; no cases of cerebral edema were reported. No deaths were attributed to CTL019. This preplanned interim analysis of a global study of CTL019 in adults with r/r DLBCL is consistent with the high response rates and durable responses observed in the previous single-center experience.

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Presenter:  Dr Giles Salles

Affiliation:  Hospices Civils de Lyon, Université de Lyon, Lyon, France

Topic:  GLOBAL PIVOTAL PHASE 2 TRIAL OF THE CD19-TARGETED THERAPY CTL019 IN ADULT PATIENTS WITH RELAPSED OR REFRACTORY (R/R) DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL)-AN INTERIM ANALYSIS

Abstract LB2604 will be presented by Giles Salles on Saturday, June 24, 11:15 - 12:45 in HALL A.

About the EHA Annual Congress
Hematology is a specialty that covers everything to do with blood: its origin in the bone marrow, diseases of blood and their treatments. The latest data on research and developments will be presented. The topics range from stem cell physiology and development, to leukemia, lymphoma, myeloma - diagnosis and treatment; red blood cells -, white blood cells- and platelet disorders; thrombosis and bleeding disorders.