On December 7, 2015 Kite Pharma, Inc. (Nasdaq:KITE) reported clinical biomarker data and product characteristics for anti-CD19 chimeric antigen receptor (CAR) T cell therapy in patients with relapsed/refractory non-Hodgkin lymphoma (NHL) enrolled in an ongoing phase 1-2 clinical trial at the National Cancer Institute (NCI), which is being conducted under a Cooperative Research and Development Agreement (CRADA) between Kite and the NCI (Press release, Kite Pharma, DEC 7, 2015, View Source [SID:1234508466]). In this clinical trial, patients with a range of B cell cancers were conditioned with cyclophosphamide and fludarabine prior to receiving anti-CD19 CAR T cell therapy.

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Two posters were presented at the ASH (Free ASH Whitepaper) meeting from the NCI trial:

"Pharmacodynamic Profile and Clinical Response in Patients with B-Cell Malignancies of Anti-CD19 CAR T-Cell Therapy." Abstract #2042; Presenter: Dr. Adrian Bot, Kite Pharma; Saturday, December 5, 2015: 5:30 – 7:30 PM Eastern.

This study analyzed the product characteristics and biological activity of the anti-CD19 CAR T cells and concluded that anti-CD19 CAR T cells are polyfunctional, capable of producing a broad range of immune modulating cytokines, chemokines and effector molecules that peak sequentially.

This analysis included 17 patients treated with a low dose conditioning chemotherapy regimen (cyclophosphamide 300-500 mg/m2/day and fludarabine 30 mg/m2/day for 3 days) of which 10 received anti-CD19 CAR T cells that were manufactured under a new process, which was co-developed with Kite. The objective response rate was 71% (35% complete remission (CR)) overall and 70% (40% CR) among those treated with cells manufactured using the new process. Grade 3 or 4 cytokine release syndrome or neurotoxicity was observed in 59% of patients and was generally reversible.

"Cyclophosphamide and Fludarabine Conditioning Chemotherapy Induces a Key Homeostatic Cytokine Profile in Patients Prior to CAR T Cell Therapy." Abstract #4426; Presenter: Dr. Adrian Bot, Kite Pharma; Monday, December 7, 2015: 6:00 – 8:00 PM Eastern.

The clinical researchers found that the conditioning regimen of cyclophosphamide and fludarabine triggered changes in several key cytokines and chemokines that could drive expansion, activation, and trafficking of CAR T cells. Preliminary results suggest that the magnitudes of rise in interleukin-15 and reduction in perforin are associated with objective responses.

David Chang, M.D., Ph.D., Kite’s Executive Vice President, Research and Development, and Chief Medical Officer, commented, "The results being reported at ASH (Free ASH Whitepaper) provide meaningful insight into the importance of an optimized conditioning chemotherapy regimen, as well as the impact of the manufacturing approach on the effect of CAR T cell therapy. These findings have guided the design of Kite’s ongoing program for KTE-C19 (anti-CD19 CAR T cell therapy), which is currently enrolling patients in multiple clinical trials to support product registration."