Phase 1 Clinical Trial Highlights:
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14 of 20 pediatric or young adult patients (70%) with relapsed or refractory ALL experienced a complete response.
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12 of the 20 patients (60%) achieved a minimal residual disease (MRD)-negative complete response.
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10 of the patients who had an MRD-negative complete response
subsequently underwent hematopoietic stem-cell transplantation, and all
10 remained disease free upon 10-month follow-up.
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The results have been published in the October 13, 2014 Issue of The Lancet
SANTA MONICA, Calif., Oct. 13, 2014 (GLOBE NEWSWIRE) -- Kite Pharma, Inc.,
(Nasdaq:KITE), a clinical-stage biopharmaceutical company focused on
developing engineered autologous T cell therapy (eACT™) products for the
treatment of cancer, today announced the publication in The Lancet
of clinical results demonstrating the potential to treat relapsed or
refractory acute lymphoblastic leukemia (ALL) with an anti-CD19 chimeric
antigen receptor (CAR) T cell therapy. Kite's most advanced product
candidate, KTE-C19, is an anti-CD19 CAR T cell therapy that involves
genetically modifying a patient's T cells to express a CAR that is
designed to target CD19, a protein expressed on the cell surface of B
cell lymphomas and leukemias.
The findings from a Phase 1 clinical trial conducted by the Pediatric Oncology Branch of the National Cancer Institute
(NCI) demonstrated that administration of anti-CD19 CAR T cells
resulted in a 70% complete response rate in 20 pediatric or young adult
patients with relapsed or refractory ALL. Sixty percent of the 20
patients achieved an MRD-negative complete response. Ten of the patients
who had an MRD-negative complete response subsequently underwent
hematopoietic stem-cell transplantation (HSCT), and all 10 remained
disease free with a median follow-up of 10 months. These and other
findings from the Phase 1 study are being published in an article
titled, "T cells expressing CD19 chimeric antigen receptors for acute
lymphoblastic leukaemia in children and young adults: a phase 1
dose-escalation trial," http://dx.doi.org/10.1016/S0140-6736(14)61403-3, which is appearing in the October 13, 2014 issue of The Lancet. Lead author on the article is Crystal L. Mackall, M.D., Head of Immunology Section and Chief of the Pediatric Oncology Branch at the National Cancer Institute.
Gary Schiller, M.D., F.A.C.P., Professor, Director, Hematological Malignancies/Stem Cell Transplantation Unit, David Geffen School of Medicine
at UCLA, commented, "This article, the first publication of an
intention-to-treat analysis from a completed clinical study of CD19-CAR
therapy in pediatric and young adult patients with relapsed/refractory
ALL, deepens our understanding of this important investigational
approach. The results show that this treatment is feasible in many
patients with ALL and can eradicate chemoresistant disease with an
acceptable toxicity profile. Further, the findings demonstrate
substantially higher response rates than seen in the literature for the
most recently approved agent for refractory ALL. CD19-CAR therapy
represents a potentially important new tool to address the urgent need
for new treatment modalities in these patients."
The open-label, Phase 1 dose-escalation study enrolled patients aged
1-30 years. Prior to the study, all patients had been heavily pretreated
for their disease. Patients received a conditioning regimen of
chemotherapy (cyclophosphamide and fludarabine) followed by a single
infusion of one of two dose levels of anti-CD19-CAR T cells. The
CAR-expressing T cells were produced from each patient's own peripheral
blood mononuclear cells (PBMCs), modified using a gammaretroviral vector
encoding the CAR, as well as a CD28 costimulatory moiety. After the
dose-escalation phase, an expansion cohort was treated at the maximum
tolerated dose. Pursuant to the study protocol, patients are continuing
to be monitored.
As seen in other studies, infusion of anti-CD19 CAR T cells was
associated with significant, acute toxicities, including fever,
hypokalemia, and transient neurological deficits. All toxicities were
fully reversible.
David Chang, M.D., Ph.D., Kite Pharma's
Executive Vice President, Research and Development, and Chief Medical
Officer, stated, "The findings of the study reported in the Lancet
further support promising results with our CD19-CAR construct in other
blood cancers, such as in patients with aggressive, refractory
non-Hodgkin's lymphoma. Toxicities were readily managed in the Lancet
study, and the findings provided important information on defining
response rates and maximum tolerated dose, as well as affirming the
feasibility of generating CD19-CAR T cells in this heavily pretreated
patient population."
Kite previously announced
positive results in chemotherapy-refractory diffuse large B-cell
lymphoma (DLBCL) in a study conducted under the auspices of Kite and the
Surgery Branch of the NCI, led by Steven A. Rosenberg, M.D., Ph.D. Kite and Dr. Rosenberg's team are collaborating under a Cooperative Research
and Development Agreement (CRADA) for the research and development of
eACT™-based product candidates for the treatment of multiple cancer
indications.
"We are greatly encouraged by the continuing strong results from the
NCI using our proprietary CD19-CAR construct in very sick patient
groups," commented Arie Belldegrun, M.D., FACS, Kite's President and
Chief Executive Officer. "The importance of a new approach to treating
advanced cancer in the youngest patients cannot be over-emphasized."
Dr. Belldegrun continued, "As previously reported, Kite plans to file
an IND this year to initiate a Phase 1-2 single-arm multicenter clinical
trial of its lead CD19-CAR therapy, KTE-C19, in patients with DLBCL who
have failed two or more lines of therapy. For the trial, we will
manufacture product using our streamlined and rapid production process.
We are excited to advance this promising therapy and anticipate
initiating our first Kite-sponsored study next year."
About Kite Pharma
Kite Pharma, Inc.,
is a clinical-stage biopharmaceutical company engaged in the
development of novel cancer immunotherapy products, with a primary focus
on eACT™ designed to restore the immune system's ability to recognize
and eradicate tumors. In partnership with the NCI Surgery Branch through
a Cooperative Research and Development Agreement (CRADA),
Kite is advancing a pipeline of proprietary eACT™ product candidates,
both CAR (chimeric antigen receptor) and TCR (T cell receptor) products,
directed to a wide range of cancer indications. Kite is based in Santa Monica, CA. For more information on Kite Pharma, please visit www.kitepharma.com.
Forward-Looking Statements
This press release contains forward-looking statements for purposes of
the safe harbor provisions of the Private Securities Litigation Reform
Act of 1995. We may, in some cases, use terms such as "predicts,"
"believes," "potential," "proposed," "continue," "estimates,"
"anticipates," "expects," "plans," "intends," "may," "could," "might,"
"will," "should" or other words that convey uncertainty of future events
or outcomes to identify these forward-looking statements.
Forward-looking statements include statements regarding our intentions,
beliefs, projections, outlook, analyses or current expectations
concerning, among other things: the success and timing of the ongoing
and anticipated clinical trials for our current product candidates,
including statements regarding the timing of initiation of our clinical
trial of KTE-C19; the ability and willingness of the NCI to continue
research and development activities relating to eACT™ pursuant to the
CRADA; our expectations regarding the clinical effectiveness and safety
of our product candidates and results of the NCI's clinical trials; our
ability to manufacture our product candidates; the timing of and our
ability to obtain and maintain U.S. Food and Drug Administration
or other regulatory authority approval of, or other action with respect
to, our product candidates and advancing a clinical trial of KTE-C19;
and our ability to protect our proprietary technology and enforce our
intellectual property rights. Various factors may cause differences
between Kite's expectations and actual results as discussed in greater
detail in Kite's filings with the Securities and Exchange Commission, including without limitation in its Form 10-Q for the quarter ended June 30, 2014.
Any forward-looking statements that we make in this press release speak
only as of the date of this press release. We assume no obligation to
update our forward-looking statements whether as a result of new
information, future events or otherwise, after the date of this press
release.
CONTACT: Kite Contact:
Cynthia M. Butitta
Chief Financial Officer and Chief Operating Officer
310-824-9999
For Media: Justin Jackson
For Investor Inquiries: Kimberly MinarovichBurns McClellan
(212) 213-0006
jjackson@burnsmc.com
kminarovich@burnsmc.com
Source: Kite Pharma, Inc.
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