Data show the potential of investigational
anti-CD19 chimeric antigen receptor T-cell therapy in patients with
previously treated blood cancers, including those with high-risk
disease
Celgene Corporation (NASDAQ: CELG) today announced that data
from the TRANSCEND CLL 004 and TRANSCEND NHL 001 trials studying
the investigational anti-CD19 chimeric antigen receptor (CAR)
T-cell therapy lisocabtagene maraleucel (liso-cel; JCAR017) in
patients with B-cell blood cancers were presented at the American
Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.
Updated results from the ongoing, open-label multicenter phase
1/2 TRANSCEND CLL 004 study (Abstract #7501) of liso-cel in
patients with relapsed/refractory (R/R) chronic lymphocytic
leukemia or small lymphocytic lymphoma (CLL/SLL) were presented in
an oral presentation today. The data included safety and efficacy
findings from 23 patients who received liso-cel infusion at one of
two dose levels: 50 × 106 or 100 × 106 total CAR-positive T cells
following lymphodepleting chemotherapy. All patients had been
previously treated with ibrutinib, and more than half had received
prior venetoclax. The median number of lines of prior therapy was
five and 83% of patients had high-risk cytogenetic features.
In the study, 22 of 23 patients were evaluable for response. The
best overall response rate was 82% (18/22), with 46% (10/22) of
patients achieving complete remission with or without complete
blood count recovery (CR/CRi). Of 20 patients evaluable for minimal
residual disease (MRD), 75% (15/20) achieved undetectable MRD
(uMRD) by blood measures (sensitivity, 10-4) and 65% (13/20)
achieved uMRD by bone marrow measures (sensitivity, 10-4).
Responses have been durable, with 83% of patients (5/6) who were in
CR/CRi at six months post liso-cel infusion showing ongoing
response.
“For patients who have failed the current standard of care
treatments for CLL, such as ibrutinib and venetoclax, there is a
need for additional treatment options,” said lead study
investigator Tanya Siddiqi, M.D., City of Hope National Medical
Center. “I am highly encouraged by this early data showing
manageable toxicity and promising clinical activity in a heavily
pretreated patient population with high-risk CLL. In this
preliminary analysis, clinical responses are rapid, deep and
durable when assessed by clinical and MRD criteria. We look forward
to further investigation of liso-cel in CLL patients who have
relapsed from or have become refractory to currently available
treatment options.”
The most common treatment-emergent adverse events (TEAEs) of any
grade were anemia (83%), cytokine release syndrome (CRS; 74%),
thrombocytopenia (74%), neutropenia (57%), and leukopenia (48%).
There were two patients with dose-limiting toxicities among the 14
patients treated at 100 × 106 total CAR-positive T cells: grade 4
hypertension in one patient; and grade 3 encephalopathy, grade 3
muscle weakness and grade 4 tumor lysis syndrome in the other
patient. Across 23 patients evaluable for safety, TEAEs of note
included grade 3 CRS (2/23), grade ≥ 3 neurological events (5/23),
and grade ≥ 3 tumor lysis syndrome (4/23). No grade 5 CRS
or neurological events occurred.
In addition to these findings from TRANSCEND CLL 004,
preliminary safety and efficacy data were presented from two
subgroup analyses from the ongoing, open-label multicenter phase 1
TRANSCEND NHL 001 trial evaluating liso-cel in patients with R/R
B-cell non-Hodgkin’s lymphoma at one of two dose levels: 50 × 106
or 100 × 106 total CAR-positive T cells following lymphodepleting
chemotherapy. The data included results from a subgroup of patients
with secondary central nervous system (CNS) lymphoma (n=9)
(Abstract #7515) and from patients with R/R mantle cell lymphoma
(MCL; n=17) (Abstract #7516). These were highlighted in a poster
discussion session on Monday, June 3.
Patients had secondary CNS lymphoma at the time of first
treatment (n=7; 6 DLBCL, 1 MCL) or retreatment with liso-cel (n=2
DLBCL), and neurological events and CRS were observed in only one
patient. Of the 6 DLBCL patients with CNS lymphoma at the time of
first retreatment with liso-cel, 4 achieved complete responses, 2
of whom are in sustained remission at more than 8 and 17 months,
respectively.
The data in patients with MCL included safety and preliminary
efficacy findings for 17 treated patients. The most common grade ≥
3 TEAEs were thrombocytopenia (41%), anemia (35%) and neutropenia
(35%). Grade ≥ 3 CRS and neurological events occurred in 6% and 12%
of patients, respectively. One fatal event of tumor lysis syndrome
was observed. The best overall response rate across dose levels was
71% (12/17); the best complete response rate was 53% (9/17). These
results are consistent with those seen in all patients treated with
liso-cel in the TRANSCEND NHL 001 study.
“We are pleased to share these new data, which continue to
demonstrate the potential of liso-cel in a range of B-cell cancers,
at this year’s ASCO,” said Alise Reicin, M.D., President, Global
Clinical Development at Celgene. “These results support our
continued commitment to broadly develop CAR T-cell therapies to
address the clinical needs of patients living with blood
cancers."
Liso-cel is not approved in any country.
About Liso-cel
Liso-cel is an investigational defined composition CD19-directed
CAR T-cell product candidate using a 4-1BB costimulatory domain.
Celgene’s lead CAR T trial, TRANSCEND NHL-001, is studying liso-cel
in adult patients with relapsed or refractory diffuse large B-cell
lymphoma, primary mediastinal B-cell lymphoma, follicular lymphoma
Grade 3B and mantle cell lymphoma.
About Celgene’s Cell Therapies
Celgene is committed to advancing the field of immune cell
therapy – from pursuing scientific breakthroughs to enabling
routine clinical use – so that more patients may benefit from the
research that may ultimately lead to these emerging treatments.
Celgene is building a portfolio of cell therapies supported by more
than 15 years of development, including several chimeric antigen
receptor (CAR) T-cell agents in registrational trials across
multiple disease states, and a growing early-stage pipeline that
expands cell therapy targets and technologies. We are advancing
cell therapies in diffuse large B-cell lymphoma, multiple myeloma
and other B-cell malignancies. These efforts underscore our belief
in the promise of cell therapy to redefine the way patients fight
cancer and to potentially transform how these diseases are
treated.
About Celgene
Celgene Corporation, headquartered in Summit, New Jersey, is an
integrated global biopharmaceutical company engaged primarily in
the discovery, development and commercialization of innovative
therapies for the treatment of cancer and inflammatory diseases
through next-generation solutions in protein homeostasis,
immuno-oncology, epigenetics, immunology and neuro-inflammation.
For more information, please visit www.celgene.com. Follow Celgene
on Social Media: Twitter, LinkedIn and Facebook.
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