In the phase II ZUMA-1 (A Phase 1-2 Multi-Center Study Evaluating KTE-C19 in Subjects With Refractory Aggressive Non-Hodgkin Lymphoma) trial of patients with aggressive non-Hodgkin lymphoma, treatment with the experimental chimeric antigen receptor T-cell (CAR T-cell) therapy, KTE-C19, induced complete remissions (CR) in 47 percent of patients and led to an objective response rate (ORR) of 76 percent (p<0.0001).
The study included 62 patients: 51 with diffuse large B-cell lymphoma (DLBCL) and 11 with either transformed follicular lymphoma (TFL) or primary mediastinal B-cell lymphoma (PMBCL). For those with DLBCL, the ORR with KTE-C19 was 76 percent, with a CR rate of 47 percent. In those with TFL/PMBCL, the ORR was 91 percent, with a CR rate of 73 percent.
The most common grade ≥3 adverse events included neutropenia (66%), anemia (40%), febrile neutropenia (29%), thrombocytopenia (29%), and encephalopathy (26%). Serious neurologic toxicity was reported in 34 percent of patients, and serious cytokine release syndrome (CRS) was reported in 18 percent of patients. Two treatment-related deaths occurred, including hemophagocytic lymphohistiocytosis and cardiac arrest related to CRS.
Kite Pharma Inc., the drug’s manufacturer, said it will present six-month follow-up data from 101 patients in early 2017 with outcomes on complete response rates.
KTE-C19 is also being assessed in combination with atezolizumab in a single-arm, open-label, multicenter, phase Ib/II study in patients with refractory DLBCL to examine the safety and efficacy of the combination. The first patient was enrolled in October.
Sources: Kite Pharma press release, September 26, 2016; Reuters, September 26, 2016; Kite Pharma press release, October 6, 2016.