The Kymriah trials’ 24-month follow-up analysis of the ELIANA study in children and young adults with r/r B-cell acute lymphoblastic leukaemia exhibited durable response rates. While, the 19-month analysis of the JULIET study in adult patients with r/r diffuse large B-cell lymphoma indicated prolonged durability of response in patients undergoing multiple rounds of chemotherapy and unsuccessful stem cell transplants.
In ELIANA, the relapse-free survival rate was 62% with the median duration of remission (mDOR) and median overall survival (mOS) remaining unreached. The probability of OS was 76% at 12 months and 66% at 24 months.
In JULIET, the mDOR was not reached at the time of analysis and the relapse-free probability remained consistent at 64% between 12-month and 18-month analyses. Median OS for all infused patients was 11.1 months and not reached for patients in CR. The OS probability was 48% and 43% at 12 and 18 months, respectively. Further, 54% of patients who had achieved a partial response converted to CR. The analyses of ORR, DOR and OS was consistent across all subgroups.
Grade 3/4 cytokine release syndrome was noted in 49% and 23% of patients in ELIANA and JULIET respectively. The safety profile was consistent with no new safety signals in ELIANA, and no deaths due to causes other than disease progression in JULIET. Around 13% and 11% of patients in ELIANA and JULIET experienced grade 3 and grade 3/4 neurological events.