Kite's Tecartus CAR T-Cell Therapy Demonstrates Durable Overall Survival Benefit In Leukemia Settings

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  • Kite, a Gilead Sciences Inc GILD company, announced the three-year follow-up results from the pivotal ZUMA-3 study of the CAR T-cell therapy Tecartus (brexucabtagene autoleucel). 
  • The analysis showed a median overall survival (OS) of 26 months and demonstrated that responses remained durable in adults with relapsed/refractory B-cell acute lymphoblastic leukemia (R/R B-ALL), with a consistent safety profile observed since the two-year analysis. 
  • In the Phase 2 treated patient cohort (n=55), the median follow-up was 38.8 months. The OS rate at 36.0 months was 47.1%, with a median OS of 26.0 months among all treated Phase 2 patients (n=55) and 38.9 months in patients with complete remission (CR) or complete remission with incomplete hematologic recovery (CRi; n=39). 
  • Overall CR rate (CR + CRi), CR, and subsequent allogeneic stem cell transplant (alloSCT) rates remained unchanged since the prior data cut at 71%, 56%, and 20%, respectively. 
  • Median relapse-free survival (RFS) was censored and not censored at subsequent alloSCT at 11.6 and 11.7 months, respectively.
  • At the data cutoff, 36% of patients (28) were still alive, with a median OS of 25.6 months.
  • Price Action: GILD shares are up 0.46% at $86.06 on the last check Thursday.
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