On March 17, 2016 Kite Pharma, Inc. (Nasdaq:KITE) reported that it has entered into a clinical trial collaboration with Genentech, a member of the Roche Group, to evaluate the safety and efficacy of KTE-C19, in combination with atezolizumab (also known as MPDL3280A), in patients with refractory, aggressive non-Hodgkin lymphoma (NHL) (Press release, Kite Pharma, MAR 17, 2016, View Source [SID:1234509602]). Schedule your 30 min Free 1stOncology Demo! KTE-C19 is an investigational immunotherapy in which a patient’s T cells are genetically modified to express a CAR designed to target the antigen CD19, a protein expressed on the cell surface of B cell lymphomas and leukemias. Atezolizumab is an investigational monoclonal antibody designed to target and bind to a protein called PD-L1, which is expressed on tumor cells and tumor-infiltrating immune cells. PD-L1 interacts with PD-1 and B7.1, both found on the surface of T cells, causing inhibition of T cells. Use of the two compounds in combination could provide a synergistic effect since inhibiting PD-L1 with atezolizumab may enhance and prolong the activity and proliferation of KTE-C19.
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"Kite is a pioneer in engineered T cell therapy, and we are excited to collaborate with Genentech, an industry leader with a history of developing transformative therapies for cancer," said Arie Belldegrun, M.D., FACS, Chairman, President and Chief Executive Officer of Kite. "KTE-C19 is currently in four pivotal studies and early clinical findings have shown a potential for breakthrough efficacy in refractory, aggressive NHL and other B cell malignancies. The scientific rationale for combining KTE-C19 and atezolizumab in refractory, aggressive NHL is compelling, and could potentially lead to opportunities to advance this combination in other indications."
A multi-center Phase 1b/2 study is expected to begin in 2016. The study will use the same KTE-C19 dose and regimen as Kite’s ongoing, potential registration study (ZUMA-1) in patients with refractory, aggressive NHL. Kite will be the sponsor of the study, and the results will be used to evaluate options for further development of the combination.
About KTE-C19
KTE-C19 is an investigational therapy in which a patient’s T cells are genetically modified to express a CAR 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. The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation status to KTE-C19, for the treatment of patients with refractory diffuse large B cell lymphoma (DLBCL), primary mediastinal B cell lymphoma (PMBCL), and transformed follicular lymphoma (TFL). KTE-C19 has also secured Orphan Drug Designation in the U.S. for DLBCL and in the EU for various hematological indications.