Kite Pharma has enrolled the first patient of ZUMA-6, a Phase 1b/2 clinical study of KTE-C19 in combination with Genentech’s anti-PD-L1 cancer immunotherapy atezolizumab.
This study is intended to analyse the safety and efficacy of the combination in patients with refractory diffuse large B-cell lymphoma (DLBCL). PD-L1 expression in DLBCL is linked with high-risk disease and poor outcomes.
The interaction of PD-L1 and PD-1, which is expressed on KTE-C19, may reduce T-cell activity in some patients. Therefore, a combination of the two compounds could offer a synergistic effect as inhibiting PD-L1 with atezolizumab may boost and prolong the activity and proliferation of KTE-C19.
Kite's executive vice-president for research and development and chief medical officer David Chang said: "The ZUMA-6 combination study is a core element of our broad strategy to optimise 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.”
In March, Kite formed a clinical collaboration with Genentech to analyse the safety and efficacy of KTE-C19 in combination with atezolizumab.
ZUMA-6 is a clinical trial to study the combination of an anti-CD19 engineered chimeric antigen receptor (CAR) T-cell and a checkpoint inhibitor. The first patient was enrolled at the end of last month.
This trial will proceed as a single-arm, open-label, multi-centre study in patients with chemotherapy-refractory DLBCL. Phase 1b will evaluate the safety of KTE-C19 and atezolizumab given in sequence. The core aim of Phase 2 is to analyse the combination’s safety and efficacy.
This trial also includes secondary analyses of key biomarkers of T-cell activity and other safety and efficacy endpoints. Kite will serve as the sponsor of the study, and the results will be used to analyse options for further development of the combination.