- Top-line results from a Phase 1/2 clinical trial, ZUMA-1, assessing Kite Pharma's (NASDAQ:KITE) lead product candidate KTE-C19 in patients with diffuse large B-cell lymphoma (DLBCL) who failed to respond to chemo showed an objective response rate (ORR) of 76%, including 47% complete remissions (CR).
- ZUMA-1 had two cohorts, #1 included patients with DLBCL and #2 enrolled patients with transformed follicular lymphoma (TFL) and primary mediastinal B-cell lymphoma (PMBCL).
- The ORR and CR for DLBCL in Phase 1 (n=7) were 71% and 57%, respectively. In Phase 2 the rates for DLBCL (n=51) were 76% and 47%, respectively. In patients with TFL/PMBCL (n=11), the rates were 91% and 73% respectively. At Month 3 the rates in Phase 1 were 43% and 43%, respectively. The rates at Month 3 in Phase 2 for each group were 39%, 33%, 64% and 64%, respectively. At Months 6 and 9, the Phase 1 rates were 43% and 43%, respectively. The data are pending for the Phase 2 groups.
- Across the 62 subjects in Phase 2, the most common serious adverse events (Grade 3 or higher) were neutropenia (66%), anemia (40%), febrile neutropenia (29%), thrombocytopenia (29%) and encephalopathy (26%). The rates of Grade 3 or higher cytokine release syndrome (CRS) and neurological toxicity were 18% and 34%, respectively. Two patients died from KTE-C19-related events (cardiac arrest and an overactive immune condition called hemophagocytic lymphohistiocytosis, both associated with CRS).
- Kite plans to pursue regulatory approval in DLBCL, TFL and PMBCL.
- Additional data will be submitted for presentation at a future scientific meeting. The primary analysis of 101 patients, including six-month follow-up data, should be available in Q1 2017.
- Management will host a conference call starting momentarily to discuss the data.
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