October 06, 2016
Kite Pharma Initiates Phase 1b/2 Combination Study for KTE-C19 and Atezolizumab in Patients with Refractory Diffuse Large B-cell Lymphoma (DLBCL)
First patient enrolled in ZUMA-6 study evaluating safety and efficacy of anti-CD19 CAR (KTE-C19) therapy in combination with anti-PD-L1 monoclonal antibody atezolizumab
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.
"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," said
Kite entered a clinical collaboration in
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.
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.
About Kite Pharma
This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The press release may, in some cases, use terms such as "predicts," "believes," "potential," "proposed," "continue," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements include statements regarding intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: the ability to advance the Phase 1b/2 combination study and expectations regarding the clinical effectiveness and safety of the combination therapy. Various factors may cause differences between Kite's expectations and actual results as discussed in greater detail in Kite's filings with the
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