Kite Pharma Announces Positive Topline KTE-C19 Data from ZUMA-1 Pivotal Trial in Patients with Aggressive Non-Hodgkin Lymphoma (NHL)
ZUMA-1 enrolled patients with chemorefractory aggressive
The interim analysis of ZUMA-1 evaluated the ORR in the first 51 patients in Cohort 1 with at least three months of follow-up. This analysis also included an additional 11 patients in Cohort 2. The table below summarizes the response rates from this interim analysis together with the previously reported results from the Phase 1 portion of ZUMA-1 (Neelapu ASCO 2016).
ZUMA-1 Phase 1 | ZUMA-1 Phase 2 | |||||||||||||||||||||||
DLBCL (n=7) |
DLBCL (n=51) | TFL/PMBCL (n=11) | Combined (n=62) | |||||||||||||||||||||
ORR (%) |
CR
(%) |
ORR (%) |
CR
(%) |
ORR
(%) |
CR
(%) |
ORR (%) |
CR
(%) |
|||||||||||||||||
ORR | 71 | 57 | 76 | 47 | 91 | 73 | 79 | 52 | ||||||||||||||||
Month 3 | 43 | 43 | 39 | 33 | 64 | 64 | 44 | 39 | ||||||||||||||||
Months 6 and 9 | 43 | 43 | Data Pending | |||||||||||||||||||||
Across the combined 62 patients, the most common grade 3 or higher adverse events included neutropenia (66 percent), anemia (40 percent), febrile neutropenia (29 percent), thrombocytopenia (29 percent), and encephalopathy (26 percent). Grade 3 or higher cytokine release syndrome (CRS) and neurological toxicity was observed in 18 percent and 34 percent of patients, respectively. Two patients died from KTE-C19 related adverse events (hemophagocytic lymphohistiocytosis and cardiac arrest in the setting of CRS).
The Phase 2 interim outcomes in ZUMA-1 are largely consistent with
results from the Phase 1 portion of the study and the
"ZUMA-1 enrolled patients with chemorefractory aggressive
Jeff Wiezorek, M.D., Senior Vice
President of Clinical Development. "ZUMA-1 is the largest CAR-T study
reported in
Additional data from this interim analysis will be submitted for
presentation at an upcoming scientific meeting. The primary analysis of
101 patients with chemorefractory aggressive
"We are grateful to the study participants and investigators who have made this important research possible. What started at the NCI over a decade ago with the pioneering work of
Steven A. Rosenberg, M.D., Ph.D.,
has evolved into a technology that has the potential to fundamentally
change the outlook of patients with cancer. For patients with aggressive
Arie Belldegrun, M.D., FACS, Chairman, President and Chief Executive Officer of Kite. "I am proud of what we have achieved to date and excited to apply our advanced learnings from ZUMA-1 to our ongoing clinical development programs to bring continued innovation to patients and the scientific community at large."
ZUMA-1 is supported in part by funding from
Conference Call and Webcast Details
Kite will host a live conference call and webcast today at 4:30PM
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About KTE-C19
Kite Pharma's lead product candidate, KTE-C19, is an investigational therapy in which a patient's T-cells are engineered to express a chimeric antigen receptor (CAR) to target the antigen CD19, a protein expressed on the cell surface of B-cell lymphomas and leukemias, and redirect the T-cells to kill cancer cells. KTE-C19 has been granted Breakthrough Therapy Designation status for DLBCL, TFL, and PMBCL by the U.S. Food and Drug Administration and Priority Medicines (PRIME) regulatory support for DLBCL in the EU.
About Kite Pharma
Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements for purposes of
the safe harbor provisions of the Private Securities Litigation Reform
Act of 1995. We may, in some cases, use terms such as "predicts,"
"believes," "potential," "proposed," "continue," "estimates,"
"anticipates," "expects," "plans," "intends," "may," "could," "might,"
"will," "should" or other words that convey uncertainty of future events
or outcomes to identify these forward-looking statements.
Forward-looking statements include statements regarding our intentions,
beliefs, projections, outlook, analyses or current expectations
concerning, among other things: expectations regarding the clinical
effectiveness and safety of KTE-C19 and timing of the primary analysis
of ZUMA-1. Various factors may cause differences between Kite's
expectations and actual results as discussed in greater detail in Kite's
filings with the
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