Kite Pharma, Inc. KITE announced that it has initiated a phase I/II study (ZUMA-4) on its lead pipeline candidate, KTE-C19, for the treatment of pediatric and young adults suffering from relapsed or refractory acute lymphoblastic leukemia (r/r ALL). The single-arm, open-label, multi-center study, which will enroll 75 patients, will be conducted in patients with ALL whose disease is refractory to or has relapsed following standard chemotherapy or hematopoietic stem cell transplantation. While the phase I portion of the study will evaluate the safety of KTE-C19, phase II will assess its efficacy and safety.
We note that KTE-C19 is the company’s anti-CD19 chimeric antigen receptor (CAR) T cell therapy.
With the commencement of ZUMA-4, the company completed initiating four studies on KTE-C19 this year. Apart from ZUMA-4, other ongoing studies include ZUMA-1 (phase II) in patients with refractory diffuse large B cell lymphoma (DLBCL) including primary mediastinal B cell lymphoma (PMBCL) and transformed follicular lymphoma (TFL), ZUMA-2 (phase II) in patients with r/r mantle cell lymphoma and ZUMA-3 (phase I/II) in adult patients with r/r ALL.
In a separate press release, Kite announced that the FDA has granted Breakthrough Therapy designation to KTE-C19, for the treatment of patients with refractory DLBCL, PMBCL and TFL. We note that all these are types of aggressive non-Hodgkin’s lymphoma (NHL).
Meanwhile, Kite presented encouraging clinical results and biomarker data from the phase I portion of the ZUMA-1 study on KTE-C19 at the annual meeting of the American Society of Hematology (ASH). Data showed four complete remissions and one partial remission representing an overall objective response rate of 71%. As far as biomarker analysis is concerned, overall product characteristics and pharmacodynamic profile of KTE-C19 were found to be consistent with what has been observed with anti-CD19 CAR T cell therapy in the ongoing study at the National Cancer Institute. The company intends to provide interim data from the pivotal phase II portion of the study in 2016.
We note that Kite is looking to revolutionize cancer treatments by engaging the body’s own immune system to treat cancer. Meanwhile, the development of CAR T cell therapies has been attracting a lot of attention lately with several companies eyeing this field. Juno Therapeutics Inc. JUNO is also working on developing therapies utilizing CAR T cell technology.
Juno also presented data at the ASH on its CAR T cell product candidates, JCAR014 (r/r B-cell NHL, ALL and chronic lymphocytic leukemia), JCAR015 and JCAR018 (r/r B-cell ALL). All three candidates demonstrated encouraging clinical responses in patients with B-cell cancers.
Currently, both Kite and Juno are Zacks Rank #3 (Hold) stocks. A couple of better-ranked stocks in the health care sector are Achillion Pharmaceuticals, Inc. ACHN and Anika Therapeutics Inc. ANIK. Both carry a Zacks Rank #1 (Strong Buy).
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