On November 3, 2016 Kite Pharma, Inc. (Nasdaq:KITE) reported that new data will be presented from multiple studies related to its lead investigational candidate, KTE-C19, at the American Society of Hematology (ASH) (Free ASH Whitepaper) 58th Annual Meeting in San Diego, CA, December 3-6, 2016 (Press release, Kite Pharma, NOV 3, 2016, View Source [SID1234516227]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"In the last year alone, Kite has made significant advancements in our efforts to transform the treatment of cancer and deliver the first, and potentially transformative, personalized CAR-T cell therapy," said David Chang, M.D., Ph.D., Executive Vice President, Research and Development, and Chief Medical Officer of Kite. "At this year’s ASH (Free ASH Whitepaper) meeting, we will show additional detail from the interim analysis from ZUMA-1 as well as new KTE-C19 data and reproducibility in our manufacturing process from our ZUMA-3 and ZUMA-4 trials. The additional data sets continue to provide deeper insights into the therapy’s potential to transform the treatment of B-cell malignancies."
Oral Presentations
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
Abstract #998 View Source
Presenter: Sattva Swarup Neelapu, M.D., The University of Texas MD Anderson Cancer Center, Houston, TX
Monday, December 5, 2016: 3:00 p.m. PST; Room 24
This oral presentation will feature initial results from Cohort 2 of the pivotal ZUMA-1 Phase 2 trial. Cohort 2 focuses on patients with chemorefractory PMBCL and TFL, both forms of aggressive non-Hodgkin lymphoma (NHL). In September 2016, Kite announced interim positive topline results from ZUMA-1 in both Cohort 1 (chemorefractory diffuse large B-cell lymphoma (DLBCL)) and Cohort 2.
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)
Abstract #1227 View Source
Presenter: Marianna Sabatino, M.D., Kite Pharma, Director of Product Sciences
Monday, December 5, 2016: 6:45 p.m. PST; Room 30
This presentation will describe the robust and reliable manufacturing process utilized in the multicenter ZUMA-3 and -4 studies for the production of KTE-C19 for patients with R/R ALL.
T cells Expressing a Novel Fully-human Anti-CD19 Chimeric Antigen Receptor Induce Remissions of Advanced Lymphoma in a First-in-humans Clinical Trial
Abstract #999 View Source
Presenter: Jennifer Brudno, M.D., Clinical Fellow, National Cancer Institute (NCI)
Monday, December 5, 2016: 3:15 p.m. PST; Room 24
This presentation will review a Phase 1 dose-escalation trial conducted to investigate the safety and efficacy of engineered T cells with a fully-human anti-CD19 chimeric antigen receptor for the treatment of advanced lymphoma. This investigational therapy is being evaluated pursuant to Kite’s Cooperative Research and Development Agreement with the NCI.
Poster Presentation
High Rates of Minimal Residual Disease-Negative (MRD−) Complete Responses (CR) in Adult and Pediatric and Patients with Relapsed/Refractory Acute Lymphoblastic Leukemia (R/R ALL) Treated With KTE-C19 (Anti-CD19 Chimeric Antigen Receptor [CAR] T Cells): Preliminary Results of the ZUMA-3 and ZUMA-4 Trials
Poster #2803 View Source
Presenter: B. Shah, M.D., Department of Hematological Malignancies, H. Lee Moffitt Cancer Center and Research Institute
Sunday, December 4, 2016: 6:00-8:00 p.m. PST; Poster II; Hall GH
This poster will review the preliminary safety and efficacy data from the Phase 1 portion of ZUMA-3 and ZUMA-4 trials of KTE-C19 in adult and pediatric patients with R/R ALL.
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.