October 07, 2016
Kite Pharma Presents 12-Month Follow-Up Data from ZUMA-1 Phase 1 at the European Society for Medical Oncology (ESMO) Annual Congress
43 Percent Complete Remission Rate Continues at 12-Month Follow-Up
"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
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:
- 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;
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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