Shares in Kite Pharma surged as much as 49.5 percent after the company reported positive early-stage data demonstrating the potential to treat aggressive non-Hodgkin's lymphoma with an anti-CD19 chimaeric antigen receptor (CAR) T-cell therapy. Chief medical officer David Chang said "both the high overall response rate and the durability of the complete remissions are noteworthy, and we believe our anti-CD19-CAR T-cell approach holds great potential for the treatment of B-cell malignancies."
Kite noted that the second cohort of the Phase I/IIa study comprised 15 patients, including two retreated from a previous cohort, with advanced B-cell malignancies. In the trial, patients received a conditioning regimen of chemotherapy followed one day later by a single infusion of anti-CD19-CAR T-cells, which were produced from each subject's own peripheral blood mononuclear cells, modified using a gammaretroviral vector encoding the CAR, as well as a CD28 costimulatory moiety.
Results, which were published in the Journal of Clinical Oncology, showed that of 13 evaluable patients, eight had complete remissions and four had partial remissions, representing an overall objective response rate of 92 percent. Kite said that of seven patients with chemotherapy-refractory diffuse large B-cell lymphoma (DLBCL), four achieved complete remissions, three of which are ongoing with durations ranging from nine months to 22 months. In addition, two of the seven patients experienced partial remissions and one had stable disease.
Kite added that the duration of ongoing complete responses ranged from 11 months to 23 months in patients with either chronic lymphocytic leukaemia or indolent lymphoma. The company noted that patients in the trial are continuing to be monitored for duration of response.
According to Kite, results from the study support the drugmaker's plan to file an IND with the FDA in the fourth quarter to initiate a clinical study of its CAR-based product candidate KTE-C19 in patients with DLBCL. The company is collaborating with the Surgery Branch of the National Cancer Institute on the development of engineered autologous T-cell therapy-based product candidates for the treatment of multiple cancer indications.
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