Kite announces findings from followup of ZUMA-2, ZUMA-3 studies

Kite, a Gilead Company, announced findings from follow-up analyses of two pivotal studies of the CAR T-cell therapy Tecartus. A comparison of two-year follow-up from ZUMA-3 and SCHOLAR-3, a retrospective historical control study, evaluating Tecartus versus standard of care in adult patients with relapsed/refractory B-cell acute lymphoblastic leukemia, was presented in a poster session at the 2022 American Society of Hematology Annual Meeting & Exposition on December 10 and simultaneously published in the Journal of Hematology & Oncology. An additional exploratory analysis on patient and product characteristics associated with long-term response from the three-year follow-up of the Phase 2 ZUMA-2 study of Tecartus in patients with R/R mantle cell lymphoma was also presented in a poster session on December 12. Finally, a comparison analysis of ZUMA-2 and SCHOLAR-2, a retrospective historical control study, evaluating Tecartus vs. SOC in adult patients with R/R MCL, was presented in a poster session on December 12. Outcomes From the Historical Control Study SCHOLAR-3 Contextualizing Updated ZUMA-3 Results of Brexucabtagene Autoleucel in Adult Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia. A propensity score matching analysis comparing follow-up from the ZUMA-3 study to matched patients from the SCHOLAR-3 external control cohort of historical clinical trials, balanced for patient characteristics demonstrated that Tecartus had superior overall survival versus SOC regardless of prior therapies In the historical clinical trials, median OS was less than six months versus greater than25 months among matched patients in ZUMA-3. In those patients who were previously naive to blinatumomab and inotuzumab, comparisons for complete remission and CR with incomplete hematological recovery at 24 weeks were also conducted. CR/CRi rates among those treated with Tecartus in ZUMA-3 were more than two times those treated with SOC Assessment of Durable Responses After Brexucabtagene Autoleucel in the ZUMA-2 Study in Relapsed/Refractory Mantle Cell Lymphoma: A separate exploratory analysis of ZUMA-2 was designed to identify factors associated with long-term response to Tecartus in adults with R/R MCL, comparing patients who remained in ongoing response at 24 months and those who had relapsed. Patients had received a median of three prior therapies, including ibrutinib as last prior therapy and acalabrutinib as last prior therapy, with a median time from last prior therapy of 63.0 and 64.5 months, respectively. A smaller proportion of ongoing responders compared with relapsed responders received bridging therapy and prior platinum therapy. Similar proportions of patients in each group had received prior bendamustine therapy, prior proteosome inhibitor therap, and prior autologous stem cell transplant . At baseline, a greater proportion of ongoing responders had an ECOG score of 0 compared to relapsed responders and the incidence of high-risk features was similar between the two groups. Levels of CAR T-cells were approximately double in ongoing versus relapsed responders. A Comparison of Overall Survival with Brexucabtagene Autoleucel CAR T-Cell Therapy and Standard of Care in Patients with Relapsed/Refractory Mantle Cell Lymphoma Previously Treated with a Covalent Bruton Tyrosine Kinase Inhibitor/ In a separate presentation, results from an indirect treatment comparison study assessing individual patient data from ZUMA-2 and the retrospective, observational, SCHOLAR-2 study, further support long-term efficacy of Tecartus in adults with R/R MCL. The study investigated the comparative efficacy of brexucabtagene autoleucel versus SOC in patients with R/R MCL who had previously been treated with Bruton Tyrosine Kinase Inhibitor therapy using three different statistical methods to adjust for imbalances between the non-randomized studied populations. These data suggested improved OS for patients treated with brexucabtagene autoleucel versus SOC, in which the median OS was 46.6 months versus 14.2, HR 0.38, inverse probability weighting adjusted, respectively.