Kite/NCI Anti-CD19 CAR T-Cell Therapy Demonstrates Durable Complete Remissions in Advanced Non-Hodgkin Lymphoma
June 06 2016 - 7:45AM
Business Wire
9 of 19 patients (47%) with diffuse large
B-cell lymphoma achieved complete responses, which are all ongoing
with a duration of 7 to 20 months
Kite Pharma, Inc. (Nasdaq:KITE) ("Kite") today announced
results to be presented at the 2016 American Society of Clinical
Oncology (ASCO) Annual Meeting from a study of low-dose
chemotherapy conditioning followed by anti-CD19 chimeric antigen
receptor (CAR) T-cell therapy. The results showed that CAR T-cell
therapy was effective in inducing a high response rate in patients
with advanced non-Hodgkin lymphoma (NHL). The results will be
presented today as a Late Breaking Abstract by James N.
Kochenderfer, M.D., an investigator in the Experimental
Transplantation and Immunology Branch of the National Cancer
Institute (NCI) Center for Cancer Research (Hall D2, Time: 4:42PM
CDT, Abstract #3010).
In this study of 22 patients (19 diffuse large B-cell lymphoma,
2 follicular lymphoma, and 1 mantle cell lymphoma), objective
responses were seen in 16 patients (73%). Twelve of 22 patients
(55%) achieved complete responses following low-dose chemotherapy
conditioning regimen. Kite is using a similar conditioning regimen
in its ZUMA-1 Study of KTE-C19, an anti-CD19 CAR T cell therapy.
Nine of 19 patients (47%) with diffuse large B-cell lymphoma
(DLBCL) achieved complete responses, which are all ongoing with a
duration of 7+ to 20+ months. Additionally, the three patients with
mantle cell lymphoma and follicular lymphoma achieved complete
responses. Reversible grade 3 or 4 neurotoxicity including
confusion, dysphasia, encephalopathy, and gait disturbances was
observed in 55% of treated patients.
“Patients with chemorefractory DLBCL have few effective
treatment options,” said Jeff Wiezorek, M.D., M.S., Kite’s Senior
Vice President, Clinical Development. “These early results are
encouraging and served as the foundation for Kite’s ongoing KTE-C19
ZUMA-1 Study.”
According to the American Cancer Society, NHL is one of the most
common cancers in the United States and DLBCL is the most common
form of the disease accounting for one out of every three cases of
NHL.1 It is estimated that approximately 26,000 people will be
diagnosed with DLBCL in the United States in 2016. DLBCL is an
aggressive and fast growing lymphoma, but considered curable in
patients who respond to initial treatment with a chemotherapy-based
regimen. Patients with chemorefractory DLBCL face limited treatment
options and historically poor outcomes.
This study was performed pursuant to a Cooperative Research and
Development Agreement (CRADA) between the NCI and Kite.
About Kite PharmaKite Pharma, Inc., is a
clinical-stage biopharmaceutical company engaged in the development
of novel cancer immunotherapy products, with a primary focus on
engineered autologous cell therapy (eACT™) designed to restore the
immune system's ability to recognize and eradicate tumors. Kite is
based in Santa Monica, CA. For more information
on Kite Pharma, please visit www.kitepharma.com. Sign up
to follow @KitePharma on Twitter
at www.twitter.com/kitepharma.
Cautionary Note on Forward-Looking StatementsThis 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 of
anti-CD19 CAR T cell 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 Kite's
Quarterly Report on Form 10-Q filed with
the SEC on May 9, 2016. 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.
References:
1. American Cancer Society. Non-Hodgkin
Lymphoma.
http://www.cancer.org/acs/groups/cid/documents/webcontent/003126-pdf.pdf
Accessed May 20, 2016
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version on businesswire.com: http://www.businesswire.com/news/home/20160606005541/en/
Kite PharmaGreg MannVP, Investor
Relationsgmann@kitepharma.comorFor Media:inVentiv HealthDavid Polk,
310-309-1029david.polk@inventivhealth.comorAnne Cummings,
212-845-5632anne.cummings@inventivhealth.com
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