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Lisocabtagene Maraleucel Demonstrates Efficacy, Manageable Safety Among Patients With R/R CLL/SLL
Phase 1/2 Results from TRANSCEND CLL 004
Phase 1/2 Results from TRANSCEND CLL 004
Primary analysis results from the TRANSCEND CLL 004 trial demonstrate that a single infusion of lisocabtagene maraleucel (liso-cel) induced complete response (CR) or remission, including with incomplete marrow recovery among patients with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
Eligible patients included those 18+ years old with R/R CLL or SLL and at least 2 previous lines of therapy, including a BTK inhibitor. Patients received an intravenous infusion of liso-cel at 1 of 2 target dose levels: 50 × 106 (dose level 1) or 100 × 106 (dose level 2) chimeric antigen receptor (CAR)-positive T-cells.
Investigators enrolled 137 patients who underwent leukapheresis at 27 sites in the USA, 117 of whom received liso-cel. All 117 participants had received and had treatment failure on a previous BTK inhibitor, and it was noted that a subset of patients had also experienced venetoclax failure.In the primary efficacy analysis set at dose level 2, the rate of CR or remission (including with incomplete marrow recovery) was statistically significant at 18% (n=9; 95% confidence interval [CI] 9-32; P =0·0006).
As for adverse events, among the patients who were treated with liso-cel, grade 3 cytokine release syndrome was reported in 9% (with no grade 4 or 5 events) and grade 3 neurological events were reported in 18% (1% grade 4, no grade 5 events). Among the 51 deaths that occurred in the study, 43 occurred after liso-cel infusion, of which 5 were due to treatment-emergent adverse events (within 90 days of liso-cel infusion). There was 1 death was related to liso-cel, which investigators determined to be caused by macrophage activation syndrome-hemophagocytic lymphohistiocytosis.
Study investigators concluded that liso-cel treatment is effective, with manageable safety, at the recommended phase 2 dose among patients with R/R CLL or SLL, “including patients who had experienced disease progression on a previous BTK inhibitor and venetoclax failure.”
Source:
Siddiqi T, Maloney DG, Kenderian SS, et al. Lisocabtagene maraleucel in chronic lymphocytic leukemia and small lymphocytic lymphoma (TRANSCEND CLL 004): A multicentre, open-label, single-arm, phase 1-2 study. Lancet. Published online on August 19, 2023. doi:10.1016/S0140-6736(23)01052-8
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