1. Complete response or remission was reported in 18% of patients who received a single liso-cel infusion.
2. Nearly 10% of fatalities were thought to be due to liso-cel related complications.
Evidence Rating Level: 1 (Excellent)
Study Rundown: There exist limited options for patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have failed treatment with both Bruton tyrosine kinase (BTK) inhibitor and venetoclax. This randomized controlled trial aimed to evaluate the use of lisocabtagene maraleucel (liso-cel), an autologous CD19-directed T-cell inhibitor, in patients with relapsed or refractory CLL or SLL. The primary outcome of this study was the rate of complete response or remission to liso-cel, while key secondary outcomes included liso-cel-related side effects such as cytokine release syndrome and neurological events. According to study results, a single infusion of liso-cel induced complete response or remission in approximately one-fifth of patients with relapsed or refractory CLL. Although this study was well done, it was limited by a relatively small sample size, thus affecting the validity of the results.
Click to read the study in The Lancet
Relevant Reading: First-Line Venetoclax Combinations in Chronic Lymphocytic Leukemia
In-depth [randomized-controlled trial]: Between Jan 2, 2018, and Jun 16, 2022, 178 patients were screened for eligibility across 27 sites in the USA. Included were patients ≥ 18 years with relapsed or refractory CLL or SLL who received ≥ 2 prior lines of therapy. Altogether, 117 patients received liso-cel and were included in the final analysis. The primary outcome of complete response or remission to liso-cel was achieved in 18% of patients in the dose level 2 (100×106) group (n=9, 95% confidence interval [CI] 9-32, p=0.0006). Treatment-related adverse events including grade 3 neurological events (18%) and grade 3 cytokine release syndrome (9%) were prominent and 10% of fatalities were thought to be directly due to liso-cel infusion. Overall, findings from this study suggest that a single infusion of liso-cel can induce complete response and remission in patients with relapsed or refractory CLL or SLL, even in the case of previously failed BTK inhibitors and venetoclax.
Image: PD
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