Kite Pharma, Inc. announced the initiation of ZUMA-6, a phase Ib/II combination study on its lead pipeline candidate, KTE-C19, in combination Genentech’s Tecentriq (atezolizumab), for the treatment of chemorefractory diffuse large B-cell lymphoma (DLBCL).
Note that Kite has inked the collaboration with Genentech, a member of the Roche Holding AG (RHHBY - Free Report) , this March, with an aim to evaluate the safety and efficacy of the combination therapy.
KTE-C19 is an investigational therapy that engineers the patient's T-cells to express a CAR to target the antigen CD19.
The ZUMA-6 study is a single-arm, open-label, multi-center study. While the phase Ib portion of the study will evaluate the safety of KTE-C19 and atezolizumab given in a sequence, the phase II portion will mainly assess the combination’s safety and efficacy. The first patient in the ZUMA-6 study was enrolled last month.
KTE-C19, is currently in a pivotal phase of the phase I-II ZUMA-1 study on patients with refractory DLBCL, including primary mediastinal B cell lymphoma (PMBCL) and transformed follicular lymphoma (TFL). All these diseases are types of aggressive non-Hodgkin’s lymphoma (NHL).
Kite is also evaluating KTE-C19 in the phase II ZUMA-2 study in patients with relapsed/refractory mantle cell lymphoma (MCL), and two other pivotal studies (phase I/II) for acute lymphoblastic leukemia (ALL), comprising ZUMA-3 for adult ALL and ZUMA-4 for pediatric ALL. Results from all these studies are expected next year.
Although Kite is one of the major players in the field of immunotherapy, there are many others, both big and small, looking to develop and bring their own immunotherapy treatments to market. The CAR space, for instance, already has companies like Juno Therapeutics Inc. (JUNO - Free Report) and Celgene Corporation (CELG - Free Report) working on their pipeline.
We note that KTE-C19 enjoys Breakthrough Therapy status for DLBCL, TFL and PMBCL in the U.S. It also has Orphan Drug status in the U.S. and the EU for DLBCL, PMBCL, ALL, mantle cell lymphoma, follicular lymphoma, and chronic lymphocytic leukemia. The candidate also enjoys Priority Medicines (PRIME) regulatory support for DLBCL in the EU.
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