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Two-Third Patients Experienced No CRS/Neurologic Events Up To Three Days After Yescarta, New Data From LBCL Study Shows

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  • Kite, a Gilead Sciences Inc company (NASDAQ: GILD), has announced new data from the ZUMA-1 Phase 1/2 trial of Yescarta (axicabtagene ciloleucel) in adult patients with relapsed or refractory large B-cell lymphoma (LBCL). Gilead will present the results at the Transplantation & Cellular Therapy Meetings.
  • In a new ZUMA-1 safety management cohort (Cohort 6), the primary objective was to assess the impact of prophylactic use of corticosteroids and earlier treatment with corticosteroids and tocilizumab on the incidence and severity of cytokine release syndrome (CRS) and neurologic events.
  • In the Cohort 6 primary analysis, no severe or life-threatening CRS occurred. Severe neurologic events occurred in 13 percent of patients, and no patients experienced fatal neurologic events at the time of data cut-off.
  • 68% of patients had no CRS or neurologic events within 72 hours of Yescarta infusion. 95% of patients in Cohort 6 responded to Yescarta, including 80 percent of patients who achieved a complete response; 63 percent of patients were in an ongoing response at the data cut-off (median study follow-up of 8.9 months). The median duration of response has not yet been reached.
  • "While previous analyses demonstrated a decrease in the severity of CRS and neurologic events with earlier steroid intervention, this study suggests that prophylactic corticosteroids may also provide a benefit without compromising efficacy," said Olalekan O. Oluwole, lead investigator of cohort 6.
  • Yescarta was the first CAR T-cell therapy to be approved by the FDA for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, and high-grade B-cell lymphoma and DLBCL arising from follicular lymphoma.
  • Price Action: GILD stock is down 0.71% at $66.81 during premarket hours on the last check Thursday.
 

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Posted-In: anaplastic large cell lymphomaBiotech News FDA General

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