The European Commission (EC) has granted approval to lisocabtagene maraleucel (liso-cel), a CD19-directed chimeric antigen receptor (CAR) T-cell therapy, for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.
Phase 2 TRANSCEND FL study
The decision is based on results from the global phase 2 TRANSCEND FL study. Among patients treated in the third-line plus setting, liso-cel demonstrated a high overall response rate of 97.1% (95% CI, 91.7–99.4) and complete response rate of 94.2% (95% CI, 87.8–97.8), the study’s primary and key secondary endpoints, respectively. The median time to first response was 0.95 months (range, 0.6 to 3.3 months) with 75.7% (95% CI, 66.0–83.0) of patients still in response at 18 months.
Safety results were consistent with the safety profile of liso-cel observed across clinical trials and approved indications, with no new safety signals observed in FL. In all patients treated in the TRANSCEND FL study (second-line plus), any grade cytokine release syndrome (CRS) occurred in 58% of patients, with 0.8% of patients experiencing grade 3 CRS. The median time to onset was six days (range, 1 to 17 days). Any grade neurologic toxicities occurred in 16% of patients, including grade 3 in 3% of patients. The median time to onset of the first event was eight days (range, 4 to 16 days).
Liso-cel is also approved in the European Union for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), high grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and FL grade 3B (FL3B), who relapsed within 12 months from completion of, or are refractory to, first-line chemoimmunotherapy, and for the treatment of adult patients with relapsed or refractory DLBCL, PMBCL, and FL3B after two or more lines of systemic therapy.
