Kite Pharma, Inc. ( KITE ) announced the publication of positive results from an ongoing phase I-IIa study on KTE-C19 in patients suffering from aggressive non-Hodgkin's lymphoma in the Aug 25, 2014 issue of the American Society of Clinical Oncology's Journal of Clinical Oncology. In the phase I-II study, KTE-C19 achieved 92% overall objective response rate.
According to Kite Pharma, out of 13 patients with advanced B-cell malignancies (including 7 patients with chemotherapy-refractory diffuse large B cell lymphoma (DLBCL)), 8 achieved complete remission, while 4 achieved partial remission. Additionally, 4 of the 7 chemotherapy-refractory DLBCL patients achieved complete remission, while 2 showed partial remission. Among these 4 patients, 3 are showing ongoing complete responses with durations ranging from 9 to 22 months.
Kite Pharma intends to file an investigational new drug (IND) application in the fourth quarter of 2014 for the commencement of a phase I-II single-arm multi-center study on KTE-C19 for the treatment of DLBCL patients who have failed two or more lines of therapy. Patient enrolment in this study is expected to begin in the first half of 2015.
We note that Gilead's ( GILD ) Zydelig is approved by the FDA for the treatment of relapsed follicular B-cell non-Hodgkin lymphoma. Seattle Genetics ( SGEN ) is currently developing SGN-CD19A for relapsed or refractory aggressive B-cell non-Hodgkin lymphoma.
KTE-C19, being the lead candidate in Kite Pharma's pipeline, we expect investor focus to remain on updates on its development.
Kite Pharma carries a Zacks Rank #3 (Hold). A better-ranked stock in the health care sector is Amgen Inc. ( AMGN ), carrying a Zacks Rank #1 (Strong Buy). Gilead also holds a Zacks Rank #1.
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