• 100 Percent of Responders Tested Negative for Minimal Residual Disease
SANTA MONICA, Calif.--(BUSINESS WIRE)--
Kite Pharma, Inc. (Nasdaq:KITE)
today announced that 82 percent of patients (9 out of 11) achieved
complete remission or complete remission with incomplete or partial
hematological recovery in a preliminary analysis of the Phase 1 ZUMA-3
and ZUMA-4 trials of KTE-C19 in adult and pediatric relapsed/refractory
acute lymphoblastic leukemia (r/r ALL). In these patients, 100 percent
of responders tested negative for minimal residual disease (MRD), which
has been shown to correlate with risk of disease relapse in ALL. The
data were presented today at the American Society of Hematology (ASH)
Annual Meeting in San Diego, CA.
In the Phase 1 trials, 13 patients were treated with KTE-C19. Eleven
patients were evaluable for response and two patients have not reached
the evaluation time point at the data cutoff. Patients received a
low-dose conditioning chemotherapy regimen based on extensive clinical
experience at the National Cancer Institute (NCI).
"We are encouraged by the KTE-C19 safety and efficacy profile in ALL
that is suggested by these data," said David Chang M.D., Ph.D.,
Executive Vice President, Research and Development, and Chief Medical
Officer of Kite. "In the Phase 1 portion of these studies, we are
enrolling patients with high disease burden to rigorously evaluate
safety and efficacy of KTE-C19. We look forward to initiating the Phase
2 portions of these studies in 2017."
Five of 13 (38 percent) patients had ≥ grade 3 cytokine release syndrome
(CRS) and five of 13 (38 percent) had ≥ grade 3 neurological events. One
patient in ZUMA-3 died from KTE-C19 related CRS and one patient in
ZUMA-4 died from a disseminated fungal infection unrelated to KTE-C19.
No cerebral edema has been observed.
KTE-C19 was successfully manufactured in these 13 patients across a
range of absolute lymphocyte and blast counts in a centralized and
streamlined process of six to eight days. The KTE-C19 manufacturing
process used in the multicenter ZUMA-3 and ZUMA-4 studies will be
discussed in an oral presentation on Monday, December 5, 2016, at 6:45
Production of Anti-CD19 CAR T Cells for ZUMA-3 and -4: Phase 1/2
Multicenter Studies Evaluating KTE-C19 in Patients with
Relapsed/Refractory B-Precursor Acute Lymphoblastic Leukemia (R/R ALL)
Kite Pharma's lead product candidate, KTE-C19, 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. KTE-C19 has been granted
Breakthrough Therapy Designation status for diffuse large B-cell
lymphoma (DLBCL), transformed follicular lymphoma (TFL), and primary
mediastinal B-cell lymphoma (PMBCL) by the U.S. Food and Drug
Administration (FDA) and Priority Medicines (PRIME) regulatory support
for DLBCL in the EU.
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 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 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 timing and
ability to complete Phase 1 of each trial and progress to Phase 2.
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 September 30, 2016. 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.
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SVP, Corporate Communications &
VP, Investor Relations
Source: Kite Pharma, Inc.
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