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.
Biotech Stock News
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.
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Kite Pharma’s (KITE) shares shot up 17.7% on positive data from a non-Hodgkin’s lymphoma study on KTE-C19. The data looks good though Kite is still several years from bringing this product to market. The data was from a phase I-IIa study and Kite intends to file an investigation new drug application later this year for a phase I-II single-arm multicenter study. This study will commence in the first half of 2015 .
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