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.
(Logo:
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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.
SOURCE European Hematology Association