SANTA MONICA, Calif.—Kite Pharma Inc. and Genentech, a member of the Roche group, have launched a clinical trial collaboration to assess the safety and efficacy of KTE-C19 in combination with atezolizumab (also known as MPDL3280A) in patients with refractory, aggressive non-Hodgkin lymphoma (NHL).
Though no specific details were disclosed, a multi-center Phase 1b/2 study is expected to begin this year. The study will follow the same KTE-C19 dose and regimen as Kite's ongoing potential registration study (ZUMA-1) in patients with refractory, aggressive NHL. Kite will sponsor the study, with the results to be used in evaluating options for further development of the drug combination.
KTE-C19 is an investigational immunotherapy in which a patient's T cells are genetically modified to express a chimeric antigen receptor designed to target the CD19 antigen, a protein expressed on the surface of B cell lymphomas and leukemias. For its part, Atezolizumab is an investigational monoclonal antibody that targets and binds PD-L1, which is expressed on the surface of tumor cells and tumor-infiltrating immune cells. PD-L1 interacts with PD-1 and B7.1, which are both found on the surface of T cells, to inhibit T cells. It is thought that combining the two compounds could offer a synergistic effect, since inhibiting PD-L1 with atezolizumab may enhance and prolong the activity and proliferation of KTE-C19.
"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," Dr. Arie Belldegrun, chairman, president and CEO of Kite, commented in a press release. "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."
The company is currently enrolling four pivotal studies, the ZUMA studies, for evaluating KTE-C19 in patients with various B cell malignancies, including refractory diffuse large B cell lymphoma (DLBCL), relapsed/refractory adult acute lymphoblastic leukemia (ALL), relapsed/refractory pediatric ALL, relapsed/refractory mantle cell lymphoma, primary mediastinal B cell lymphoma (PMBCL) and transformed follicular lymphoma (TFL). KTE-C19 has received Breakthrough Therapy Designation status from the U.S. Food and Drug Administration for the treatment of patients with DLBCL, PMBCL and TFL. It has also received Orphan Drug Designation in the United States for DLBCL and within the European Union for various hematological indications.
Kite Pharma announced earlier this week that it would be making two oral presentations and two poster presentations at the upcoming AACR annual meeting. The presentations will focus on KTE-C19, including updated Phase 1 results from its ZUMA-1 study, and an engineered T cell receptor product candidate that targets the cancer testis antigen MAGE-A3, which is being studied under a Cooperative Research and Development Agreement between Kite and the National Cancer Institute.