On November 21, 2016 Kite Pharma, Inc. (Nasdaq:KITE) reported that data from the interim analysis of the pivotal ZUMA-1 trial of KTE-C19 in patients with chemorefractory aggressive non-Hodgkin lymphoma (NHL) have been accepted as an oral late-breaking presentation at the American Society of Hematology (ASH) (Free ASH Whitepaper) 58th Annual Meeting in San Diego, CA, on December 6, 2016 (Press release, Kite Pharma, NOV 21, 2016, View Source [SID1234516710]). The abstract was one of only six accepted in this category and will be included in the December 1 online issue of Blood. Schedule your 30 min Free 1stOncology Demo! "Outcomes for patients with aggressive NHL depend on whether their disease is sensitive to chemotherapy. The ZUMA-1 study was designed to support registration of KTE-C19 by enrolling a well-defined chemorefractory patient population," said Jeff Wiezorek, M.D., Senior Vice President of Clinical Development of Kite. "We are pleased with the outcome of the study to date and thank the patients and investigators for their participation in the first positive pivotal study in CAR-T therapy."
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The abstract, titled "KTE-C19 (anti-CD19 CAR T Cells) Induces Complete Remissions in Patients with Refractory Diffuse Large B-Cell Lymphoma (DLBCL): Results from the Pivotal Phase 2 ZUMA-1," will be presented by Sattva S. Neelapu, M.D., Associate Professor at the University of Texas MD Anderson Cancer Center, Houston, TX.
Session Information
Session Name: Late-Breaking Abstracts Session
Session Date: Tuesday, December 6, 2016
Session Time: 7:30 AM – 9:00 AM PT
Presentation Time: 8:45 AM PT
Room: San Diego Convention Center, Hall AB
This oral presentation will feature interim results from the ZUMA-1 Phase 2 trial. In September 2016, Kite announced ZUMA-1 positive interim topline results (objective response rate 79 percent; complete remission rate 52 percent) from 62 patients with 3 months of follow-up in both Cohort 1 and Cohort 2. Cohort 1 included patients with DLBCL, and Cohort 2 enrolled patients with transformed follicular lymphoma (TFL) and primary mediastinal B-cell lymphoma (PMBCL). Details of data available at the time of interim analysis, including 93 patients who had the opportunity to be followed for one month, will be presented in the late-breaker presentation on December 6, 2016. Cohort 2 data will be covered in a separate oral presentation on December 5, 2016: Abstract #998, A Phase 2 Multicenter Trial of KTE-C19 (anti-CD19 CAR T Cells) in Patients with Chemorefractory Primary Mediastinal B-Cell Lymphoma (PMBCL) and Transformed Follicular Lymphoma (TFL): Interim Results From ZUMA-1, View Source
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 (FDA) and Priority Medicines (PRIME) regulatory support for DLBCL in the EU.