On October 7, 2016 Kite Pharma, Inc. (Nasdaq:KITE) reported updated results from the Phase 1 portion of Kite’s ZUMA-1 clinical trial of its lead product candidate, KTE-C19, in patients with chemorefractory, aggressive non-Hodgkin lymphoma (NHL) (Press release, Kite Pharma, OCT 7, 2016, View Source [SID:SID1234515649]). The results were provided in an oral presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) annual congress. KTE-C19 is an investigational therapy in which a patient’s T cells are genetically modified to express a chimeric antigen receptor (CAR) that is designed to target the antigen CD19, a protein expressed on the cell surface of B-cell lymphomas and leukemias.
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"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., Moffitt Cancer Center, Tampa, FL; Friday, October 7, 2016: 4:00-5:30pm CEST; Proffered Paper session: Immunotherapy of Cancer (SITC) (Free SITC Whitepaper); Location: Copenhagen.
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 (Free ESMO Whitepaper) 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; Saturday, October 8, 2016: 1:00-2:00pm CEST; Poster Display session; Location: Hall E.
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; Saturday, October 8, 2016: 1:00-2:00pm CEST; Poster Display session; Location: Hall E.
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; Monday, October 10, 2016: 1:00-2:00pm CEST; Poster Display session; Location: Hall E.
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.