Kite Pharma Presents 12-Month Follow-Up Data from ZUMA-1 Phase 1 at the European Society for Medical Oncology (ESMO) Annual Congress
"These data complement our recently reported interim topline results from ZUMA-1 Phase 2 and support the potential for KTE-C19 to be a breakthrough therapy for chemorefractory, aggressive NHL," said
David Chang, M.D., Ph.D., Executive Vice President, Research and Development, and Chief Medical Officer of Kite. "We are encouraged that the complete remission rate of 43 percent in the Phase 1 portion of the study continues through month 12 and look forward to reporting additional data on the durability of response to KTE-C19 from the Phase 2 portion of ZUMA-1 in 2017."
A summary of the 12-month follow-up data from the Phase 1 portion of the ZUMA-1 study is provided below.
Ongoing complete remissions in phase 1 of ZUMA-1: a phase 1-2 multi-center study evaluating the safety and efficacy of KTE-C19 (anti-CD19 CAR T cells) in patients with refractory aggressive B cell non-Hodgkin Lymphoma (NHL). Abstract 1048O; Presenter:
Frederick
Locke, M.D.,
- Phase 1 of ZUMA-1 treated a total of 7 patients with chemorefractory, diffuse large B-cell lymphoma (DLBCL)
-
KTE-C19 related adverse events consisted predominantly of cytokine
release syndrome (CRS) and neurotoxicity which were generally
reversible
- Grade 3 or higher CRS was observed in 14 percent and neurotoxicity in 57 percent; all were reversible except in one patient with dose-limiting toxicity
- KTE-C19 achieved rapid and durable responses in patients with chemorefractory disease (objective response rate 71 percent, complete remission rate 57 percent)
- Ongoing complete remissions were observed in 3 of 7 patients as of 12-month study follow-up
Three additional posters relating to KTE-C19 clinical trials in progress will also be presented at ESMO 2016.
ZUMA-1: A phase 2 multi-center study evaluating anti-CD19 chimeric
antigen receptor (CAR) T cells in patients with refractory aggressive
non-Hodgkin lymphoma (NHL). Abstract 943TiP;
ZUMA-2: A phase 2 multi-center study evaluating the efficacy of
KTE-C19 (Anti-CD19 CAR T cells) in patients with relapsed/refractory
Mantle cell lymphoma (R/R MCL). Abstract 945TiP;
ZUMA-3: A phase 1/2 multi-center study evaluation the safety and
efficacy of KTE-C19 anti-CD19 CAR T cells in adult patients with
relapsed/refractory B precursor acute lymphoblastic leukemia (R/R ALL). Abstract
415TiP;
About KTE-C19
Kite Pharma's lead product candidate, KTE-C19, is an investigational therapy in which a patient's T cells are engineered to express a 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 and Priority Medicines (PRIME) regulatory support for DLBCL in the EU.
About Kite Pharma
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. 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 ZUMA-1,
including obtaining and reporting results from the trial. Various
factors may cause differences between Kite's expectations and actual
results as discussed in greater detail in Kite's filings with the
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