Kite Doses First Patient in the Phase 2 Trial of Axicabtagene Ciloleucel in Indolent B-Cell Non-Hodgkin Lymphoma (ZUMA-5)
02 August 2017 - 10:30PM
Business Wire
- ZUMA-5 Expands Axi-Cel Clinical Program
Targeting B-Cell Malignancies
- Indolent B-Cell NHL (iNHL) Estimated to
Comprise Approximately 25 Percent of All 2017 Newly Diagnosed NHL
Cases, with Follicular Lymphoma (FL) Being the Most Common
Subtype
- First Multi-Center CAR-T Trial for
iNHL
Kite Pharma, Inc., (Nasdaq:KITE), a leading cell therapy
company, today announced that patients with relapsed/refractory
indolent B-cell non-Hodgkin lymphoma (iNHL) are now being treated
in its Phase 2 ZUMA-5 trial with its lead investigational
candidate, axicabtagene ciloleucel (axi-cel). This study builds
upon early clinical results using the same axi-cel anti-CD19
construct previously published in the March 2012 issue of Blood,
“B-cell Depletion and Remissions of malignancy along with
cytokine-associated toxicity in a clinical trial of anti-CD19
chimeric-antigen-receptor-transduced T cells,”1 in which patients
with relapsed/refractory iNHL experienced a high response rate and
durable disease remissions in a clinical trial at the National
Cancer Institute (NCI).
“Despite recent advances in the treatment of NHL, iNHL generally
remains an incurable disease. As a result, there is a great unmet
need in patients with high-risk disease which is why the focus of
this study has the opportunity to make a difference,” said David
Chang, M.D., Ph.D., Executive Vice President of Research and
Development and Chief Medical Officer of Kite. “The dosing of the
first patient in ZUMA-5 marks an important milestone in our
commitment to serving patients. We will continue to explore the
potential for axi-cel to treat hematologic malignancies beyond
aggressive NHL, the foundation of our CAR-T program.”
B-cell iNHL is expected to account for approximately 25 percent
of 2017 newly diagnosed NHL cases in the United States (U.S.).
Follicular lymphoma is the most common type of iNHL and one of the
most common subtypes of NHL. The company estimates that there will
be approximately 4,700 patients in 2017 with follicular lymphoma in
the U.S. who could potentially benefit from CAR-T therapy.
ZUMA-5 is a single-arm, open-label, multi-center study in
patients with iNHL whose disease has relapsed within two years of
first line treatment, is refractory to second line or greater
therapy or has relapsed at any point after transplant. The study
will enroll approximately 50 patients. Additional details about
this study can be found on ClinicalTrials.gov, using identifier
NCT: 03105336.
About axicabtagene ciloleucel
Kite’s lead product candidate, axicabtagene ciloleucel is an
investigational therapy in which a patient's T cells are engineered
to express a chimeric antigen receptor (CAR) to target the antigen
CD19, a protein expressed on the cell surface of B-cell lymphomas
and leukemias, and redirect the T cells to kill cancer cells.
Axicabtagene ciloleucel is currently under review by the U.S. Food
and Drug Administration (FDA) for aggressive non-Hodgkin’s lymphoma
and was granted Breakthrough Therapy Designation status for diffuse
large B-cell lymphoma (DLBCL), transformed follicular lymphoma
(TFL), and primary mediastinal B-cell lymphoma (PMBCL).
About Kite
Kite is a biopharmaceutical company engaged in the development
of innovative cancer immunotherapies with a goal of providing
rapid, long-term durable response and eliminating the burden of
chronic care. The company is focused on chimeric antigen receptor
(CAR) and T cell receptor (TCR) engineered cell therapies designed
to empower the immune system's ability to recognize and kill
tumors. Kite is based in Santa Monica, CA. For more
information on Kite, please visit www.kitepharma.com. Sign up
to follow @KitePharma on Twitter at www.twitter.com/kitepharma.
Cautionary Note on 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. The press release 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 intentions, beliefs,
projections, outlook, analyses or current expectations concerning,
among other things: the ability to advance the ZUMA-5 clinical
trial and the estimated number of patients with follicular lymphoma
in the U.S. who could potentially benefit from CAR-T therapy.
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 March 31, 2017.
Any forward-looking statements that are made in this press release
speak only as of the date of this press release. Kite assumes no
obligation to update the forward-looking statements whether as a
result of new information, future events or otherwise, after the
date of this press release.
1 Kochenderfer, J. N., et al. “B-Cell Depletion and Remissions
of Malignancy along with Cytokine-Associated Toxicity in a Clinical
Trial of Anti-CD19 Chimeric-Antigen-Receptor-Transduced T Cells.”
Blood, vol. 119, no. 12, Mar. 2012, pp. 2709–2720.,
doi:10.1182/blood-2011-10-384388.
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version on businesswire.com: http://www.businesswire.com/news/home/20170802005471/en/
KITE CONTACTS:Christine CassianoSVP, Corporate Communications
& Investor Relationsccassiano@kitepharma.comorGreg MannVP,
Investor Relationsgmann@kitepharma.com
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