Label Update for Gilead CAR T-Cell Therapy Yescarta, Improves Management of Cytokine Release Syndrome

 Kite, a Gilead Company (Nasdaq: GILD), today announced the U.S. Food and Drug Administration (FDA) has approved an update to the prescribing information for Yescarta® (axicabtagene ciloleucel) to include use of prophylactic corticosteroids across all approved indications. Yescarta is now the first and only chimeric antigen receptor (CAR) T-cell therapy with information in the label to help physicians manage, and potentially prevent, treatment side effects.

The label update is based on the results of a new safety management cohort (Cohort 6) of the pivotal ZUMA-1 study, which was designed to assess the impact of prophylactic use of corticosteroids and earlier treatment with corticosteroids and/or tocilizumab and prophylactic levetiracetam on the incidence and severity of cytokine release syndrome (CRS) and neurologic events. In the cohort, no Grade ≥3 CRS events occurred [0% (0/39) of patients in Cohort 6 compared to 13% (14/108) in the pivotal Cohorts 1/2]. Grade ≥3 neurologic events occurred in 13% of patients at the time of data cut-off, and one patient experienced a late onset Grade 5 event following the data cut-off [13% (5/39) of patients in Cohort 6 compared to 31% (33/108) in the pivotal Cohorts 1/2]. Cohort 6 shows CRS median time to onset of five days with a range from 1-15 days, and neurotoxicity median time to onset of six days with a range from 1-274 days in patients that experienced these complications.

Additional data recently published shows 68% of patients had no CRS or neurologic events within 72 hours of Yescarta infusion (27/40).1 Helping to address the potential concern that steroid use might impact efficacy, the Cohort 6 one-year update presented at the American Society of Hematology (ASH) in December 2021 suggest that Cohort 6 toxicity management strategy can improve certain adverse events without compromising the activity of Yescarta.2 Patients in Cohort 4 and Cohort 6 were found to have received median cumulative steroid doses that were lower than those used in matched Cohorts 1/2 who received steroids to manage CRS or neurologic events when they occurred.3 [1Oluwole OO, et al. Br J Haematol. 2021;194:690-700 and 2Oluwole OO, et al. 2021 ASH Annual Meeting and Exposition; December 11-14, 2021; Atlanta, GA. Abstract 2832 and 3Topp et al. Br J Haematol. 2021;195(3):388-398.]

“These new data will enable doctors to more easily and confidently manage treatment for patients,” said Frank Neumann, MD, PhD, Kite’s Global Head of Clinical Development. “Since the first approval of Yescarta, Kite has worked closely with physicians to optimize all aspects of CAR T-cell therapy to enable as many patients as possible to have the chance to benefit from this treatment. Our responsibility includes research to expand into new diseases and earlier lines of treatment, but also continuously improving the efficacy and safety of our existing CAR T therapies.”

https://www.streetinsider.com/Business+Wire/U.S.+FDA+Approves+New+Label+Update+for+CAR+T-Cell+Therapy+Yescarta%C2%AE+Showing+Prophylactic+Steriod+Use+Improves+Management+of+Cytokine+Release+Syndrome/19528516.html