Recently, Novartis announced at the 23rd European Society of Hematology Annual Meeting (EHA) 14 months of the key phase II JULIET study of Kymriah (tisagenlecleucel) in the treatment of adult relapsed or refractory diffuse large B-cell lymphoma (DLBCL). Follow-up data.
In this study, called JULIET, a total of 93 adult patients with DLBCL were enrolled. The data showed that the overall efficiency (ORR) of these 93 patients was 52% (95% [CI], 41% - 62%). 40% of them were complete remission (CR), 12% were partial remission (PR), and patients who were able to maintain CR status until the 12th month in all patients who achieved complete remission in the third month after receiving treatment The ratio is 80%, and the median response duration data is not yet mature.
In the JULIET study, the patient's first response to Kymriah (n=48) had a 12-month recurrence-free probability of 65%, and 54% (13/24) of patients with partial response successfully converted to complete remission.
In terms of survival, among all patients receiving cell infusion (n = 111) (95% CI, 6.6-NE), the OS rate was 49% at 12 months and the median OS was 11.7. month. The median time from infusion to data cutoff was 14 months and the longest infusion was 23 months. At the time of data cutoff, none of the patients after Kymriah treatment received a stem cell transplant.
In terms of safety, within 8 weeks after infusion of Kymriah, the proportion of patients with grade 3/4 cytokine storm (CRS) was 22% (level 3 14%, grade 8%), and 15% of patients (including occurrence 2) 3% of patients with grade CRS and 50% of patients with grade 3 CRS received tocilizumab to fight CRS, and no cerebral edema-related deaths were reported in the study.
On May 2 this year, the US FDA announced the approval of Novartis's CAR-T therapy Kymriah (tisagenlecleucel, CTL019) for the treatment of adult patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) ( Previously received two or more systemic treatments), this is the second indication for FDA approval of Kymriah. In August 2017, Kymriah was approved for marketing. The first indication was for the treatment of acute lymphoid B-precursor Leukemia (ALL), and patients under 25 years of age who are refractory or have relapsed twice or more, are the first CAR-T therapies approved in human history.
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