Long-term follow-up data from the phase II JULIET study are providing hope that the chimeric antigen receptor (CAR) T-cell therapy tisagenlecleucel (Kymriah) could represent a cure for patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL), according to Peter Borchmann MD.
, Borchmann shed light on the updated JULIET data and how tisagenlecleucel fits into the paradigm of DLBCL.
OncLive: Can you discuss the study’s design and the results?
: JULIET is a very important trial in patients with relapsed/refractory DLBCL failing at least 2 prior lines of systemic therapies. In this patient population, we have a very high unmet medical need. The OS in this patient cohort is short, with a median OS of approximately 4 months.
We also have very encouraging survival curves. We have an OS at 12 months for the entire cohort of 49% and for the CR patients, it is 95%. The median OS for all patients, including those failing treatment, is 11.7 months, and, obviously, it has not been reached for the CR patients because of the plateau—it's way above 50% for these patients. This is good news for the patients.
Did you learn anything about safety with the longer follow-up?
We had a closer look at safety signals in the study. There are some safety aspects of special interest in CAR T-cell therapy: cytokine release syndrome (CRS) and neurological events. We observed CRS in many patients; 58% of patients experienced some grade of CRS but only a few of them experienced grade 3 or greater at 22%. Fortunately, and importantly, none of them died due to CRS, so it could be managed.
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