On June 16th, Novartis announced the 14-month follow-up data of Kymriah (tisagenlecleucel) in the critical Phase II JULIET study of adult relapsed or refractory diffuse large B-cell lymphoma (DLBCL) at the EHA 2018 conference.
The data shows that in 93 evaluable patients, the ORR at the 14th month was 52%, 40% of which was complete remission (CR), and 12% was partial remission. Of all patients achieving complete remission in the 3rd month after treatment, the proportion of patients who were able to maintain the CR status to 12 months was 80%, and the median response duration data was not yet mature.
In the JULIET study, patients who first responded to Kymriah (n=48) had a 65% relapse-free probability of 65%. 54% (13/24) of the patients who had partial response successfully converted to complete remission.
In terms of survival, the median OS of all patients receiving infusion (n=111) was 11.7 months, and the 12-month overall survival rate was 49%. Median OS data for patients achieving complete remission are not yet mature.
In terms of safety, the proportion of patients with grade 3/4 cytokine storm (CRS) within 8 weeks after Kymriah infusion was 22% (14% for grade 3, 8% for grade 4). 15% of patients (including 3% of patients with grade 2 CRS and 50% of patients with grade 3 CRS) received tocilizumab to combat CRS. No brain edema-related deaths have been reported in the study.
On May 2 this year, the FDA approved Kymriah’s second indication for adult patients with relapsed or refractory large B-cell lymphoma who have undergone more than two systematic treatments, including diffuse large B. Cell lymphoma (DLBCL, the most common non-Hodgkin’s lymphoma) and high-grade B-cell lymphoma arising from follicular lymphoma (FL).