On June 8, 2016 Kite Pharma, Inc. (Nasdaq:KITE) ("Kite"), a clinical-stage biopharmaceutical company focused on developing engineered autologous T-cell therapy (eACT) products for the treatment of cancer, reported three oral presentations relating to its clinical programs will be delivered at the upcoming 2016 European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress in Copenhagen, Denmark, June 9-12, 2016 (Press release, Kite Pharma, JUN 8, 2016, View Source [SID:1234513140]).

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"We are excited to showcase the progress we have made with personalized T-cell immuno-oncology for people with refractory lymphoma and to share our understanding of the outcomes for this patient population who have limited or no treatment options," said Arie Belldegrun, M.D., FACS, Chairman, President, and Chief Executive Officer of Kite. "These data are important to advance our novel breakthrough personalized treatments and ultimately address critical unmet medical needs."

Updated data from Phase 1 of Kite’s ZUMA-1 study of KTE-C19 in patients with chemorefractory non-Hodgkin lymphoma (NHL) will be presented in an oral presentation. An additional oral presentation will feature data from the SCHOLAR-1 study, the first and largest meta-analysis of outcomes in patients with chemorefractory diffuse large B-cell lymphoma (DLBCL), an aggressive and common form of NHL that is difficult to treat. Patients with chemorefractory DLBCL have not responded to prior treatment with chemotherapy or have relapsed within a year after autologous stem cell transplantation.

Data from a Phase 1-2a study evaluating anti-CD19 CAR T-cell therapy after low-dose chemotherapy in people with advanced lymphoma will also be highlighted in an oral presentation. This study is being conducted as part of a Cooperative Research and Development Agreement (CRADA) between Kite and the National Cancer Institute (NCI).

Kite also recently announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) and Committee for Advanced Therapies (CAT) has granted access to its newly established Priority Medicines (PRIME) regulatory initiative for KTE-C19 in the treatment of patients with refractory DLBCL. PRIME provides early and enhanced regulatory support to optimize regulatory applications and speed up the review of medicines that address a high unmet need. KTE-C19 is an investigational therapy in which a patient’s T cells are genetically modified to express a chimeric antigen receptor (CAR) designed to target the antigen CD19, a protein expressed on the cell surface of B-cell lymphomas and leukemias.

Oral presentations at the 2016 EHA (Free EHA Whitepaper) Annual Congress:

Results from SCHOLAR-1: Outcomes in patients with refractory aggressive diffuse large B-cell lymphoma (DLBCL)

Date: Saturday, June 11, 2016, 5:00 – 5:15 PM CEST
Location: Hall A1
Abstract Number: S481
Presenter: Christian Gisselbrecht, M.D., The Lymphoma Academic Research Organisation (LYSARC), Pierre-Bénite, France

Updated results from ZUMA-1: A phase 1-2 multicenter study evaluating the safety and efficacy of KTE-C19 (anti-CD19 CAR T cells) in refractory aggressive B-cell Non-Hodgkin Lymphoma (NHL)

Date: Sunday, June 12, 2016, 8:45 – 9:00 AM CEST
Location: Hall A1
Abstract Number: S791
Presenter: Tanya Siddiqi, M.D., City of Hope National Medical Center, Duarte, CA

Low-dose chemotherapy followed by anti-CD19 chimeric antigen receptor (CAR) T cells induces remissions in patients with advanced lymphoma

Date: Sunday, June 12, 2016, 9:00 – 9:15 AM CEST
Location: Hall A1
Abstract Number: S792
Presenter: Stephanie L. Goff, M.D., Surgery Branch, Center for Cancer Research, The National Cancer Institute, Bethesda, MD

About Kite’s ZUMA Clinical Programs for KTE-C19

KTE-C19 is an investigational therapy in which a patient’s T cells are genetically modified to express a CAR that is designed to target the antigen CD19, a protein expressed on the cell surface of B-cell lymphomas and leukemias. Kite is currently enrolling four pivotal studies (also known as ZUMA studies) for KTE-C19 in patients with various B-cell malignancies.

Study Phase Indication Status
ZUMA-1
NCT02348216 Phase 2 Pivotal
(N=112) Chemorefractory DLBCL, PMBCL, TFL Phase 2 enrolling
ZUMA-2
NCT02601313 Phase 2 Pivotal
(N=70) Relapsed/refractory MCL Phase 2 enrolling
ZUMA-3
NCT02614066 Phase 1/2 Pivotal
(N=75) Relapsed/refractory Adult ALL Phase 1/2 enrolling
ZUMA-4
NCT02625480 Phase 1/2 Pivotal
(N=75) Relapsed/refractory Pediatric ALL Phase 1/2 enrolling

DLBCL = diffuse large B-cell lymphoma
PMBCL = primary mediastinal B-cell lymphoma
TFL = transformed follicular lymphoma
MCL = mantle cell lymphoma
ALL = acute lymphoblastic leukemia