September 17, 2021
Tisagenlecleucel showed durable activity and manageable safety profiles in adult patients with relapsed or refractory aggressive B-cell lymphomas, according to a long-term follow-up analysis published in The Lancet. Tisagenlecleucel (Novartis) is an autologous chimeric antigen receptor (CAR) T-cell therapy that targets the CD19 protein common to B cells.
In this analysis, investigators followed patients from the multicenter, open-label, single-arm, Phase 2 JULIET trial, in which patients with relapsed or refractory large B-cell lymphomas received a single intravenous infusion of tisagenlecleucel (Novartis). The trial enrolled 167 patients between July 2015 and November 2017.
As of Feb. 20, 2020, 115 patients had received tisagenlecleucel infusion and were included in the full analysis set. At a median follow-up of 40.3 months, 61 of 115 (63%) of patients responded, and 45 (39%) patients had a complete response as their best overall response. The most common adverse events were anemia, decreased neutrophil count, decreased white blood cell count, decreased platelet count and cytokine release syndrome. There were no treatment-related deaths.
According to investigators, the findings demonstrate that tisagenlecleucel compares favorably with respect to risk–benefit relative to conventional therapeutic approaches in patients with large B-cell lymphomas that are refractory to chemoimmunotherapy or relapsing after second-line therapies.