Date: 2016-03-17
Type of information: Clinical research agreement
Compound: axicabtagene ciloleucel (KTE-C19 (autologous T cells transduced with retroviral vector encoding an anti-CD19 CD28/CD3 zeta chimeric antigen receptor) and atezolizumab
Company: Kite Pharma (USA - CA) Roche (Switzerland)
Therapeutic area: Cancer - Oncology
Type agreement: clinical research
Action mechanism: cell therapy/immunotherapy product/gene therapy/CAR-T cell therapy/immunotherapy product/monoclonal antibody/immune checkpoint inhibitor. KTE-C19 is Kite Pharma's lead product candidate in which a patient's T cells are genetically modified using a gammaretroviral vector 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. Atezolizumab is a 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.
Disease: refractory, aggressive non-Hodgkin lymphoma (NHL)
Details: * On March 17, 2016, Kite Pharma announced 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). 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.
Financial terms:
Latest news: * On October 6, 2016, Kite Pharma announced the first patient was enrolled in ZUMA-6, a Phase 1b/2 clinical study of KTE-C19 in combination with atezolizumab, Genentech's anti-PD-L1 cancer immunotherapy. The trial is designed to evaluate the safety and efficacy of the combination in patients with refractory diffuse large B-cell lymphoma (DLBCL). The first ZUMA-6 patient was enrolled at the end of September 2016 . Kite is the sponsor of the study, and the results will be used to evaluate options for further development of the combination
