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news.Kite Pharma has enrolled first patient in ZUMA-6, a phase 1b/2 clinical study of KTE-C19 in combination with atezolizumab, Genentech's anti-PD-L1 cancer immunotherapy.
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The trial is designed to evaluate the safety and efficacy of the combination in patients with refractory diffuse large B-cell lymphoma (DLBCL).
PD-L1 expression in DLBCL is associated with high-risk disease and poor outcomes. The interaction of PD-L1 and PD-1, which is expressed on KTE-C19, may dampen T-cell activity in some patients.
As a result, 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.
Kite's Executive Vice President, Research and Development, and Chief Medical Officer, David Chang said: "The ZUMA-6 combination study is a core element of our broad strategy to optimize KTE-C19 treatment outcomes and to significantly extend the important potential benefits of KTE-C19 monotherapy.
"We view the scientific rationale for this combination study as compelling and look forward to advancing the study based on our extensive clinical experience."
Kite entered a clinical collaboration in March 2016 with Genentech, a member of the Roche Group, to evaluate the safety and efficacy of KTE-C19 in combination with atezolizumab. The first ZUMA-6 patient was enrolled at the end of September 2016.
About ZUMA-6
ZUMA-6 is the first industry-sponsored clinical trial to enroll patients to study the combination of an anti-CD19 engineered chimeric antigen receptor (CAR) T-cell and a checkpoint inhibitor. The study will proceed as a single-arm, open-label, multi-center study in patients with chemotherapy-refractory DLBCL.
The Phase 1b portion of ZUMA-6 will assess the safety of KTE-C19 and atezolizumab given in sequence. The primary objective of the Phase 2 portion is to evaluate the combination's safety and efficacy.
The study also includes secondary analyses of key biomarkers of T-cell activity and other safety and efficacy endpoints. Kite will be the sponsor of the study, and the results will be used to evaluate options for further development of the combination. Additional information about the ZUMA-6 study will be available at www.clinicaltrials.gov by searching on NCT 02926833.
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 and Priority Medicines (PRIME) regulatory support for DLBCL in the EU.