Liso-Cel Effective, Safe for Pretreated Relapsed or Remitting MCL

According to primary analysis of results from the TRANSCEND NHL 001 study recently published in the Journal of Clinical Oncology, lisocabtagene maraleucel (liso-cel) shows clear effectiveness and favorable safety as management for heavily pretreated relapsed or remitting mantle cell lymphoma (MCL).

“The current study expands knowledge about [chimeric antigen receptor] T-cell therapy and the clinical landscape of [relapsed or remitting] MCL in patients with aggressive disease and high-risk features, including those with older age and moderate comorbidities,” wrote lead author Michael Wang, MD, of the University of Texas MD Anderson Cancer Center in Houston.

This phase I, multicenter, seamless design study enrolled patients who had received at least two prior interventions for MCL. It featured a cohort of 88 leukapheresed patients who received liso-cel, 73% of whom were aged 65 years or older. The patients in this cohort had received a median of three prior lines of therapy, and 30% of the cohort had received five or more previous lines. A total of 69% of patients had refractory disease and 53% had disease refractory to Bruton’s tyrosine kinase inhibitors.

The study’s efficacy set comprised 83 patients, and they had a median on-study follow-up of 16.1 months. The objective response rate observed in this group was 83.1%, and the complete response rate was 72.3%. The median duration of response was 15.7 months, and median progression-free survival was 15.3 months.

Regarding grade 3 or worse treatment-emergent adverse events that affected patients in the efficacy set, the most common was neutropenia, with a 56.0% prevalence, followed by anemia (37.5%) and thrombocytopenia (25.0%).

Also among the safety results from the efficacy set, 61% of patients reported cytokine release syndrome (CRS). A total of 1% of patients reported grade 3 or 4 severity CRS and none reported grade 5. Neurologic events were reported in 31% of patients, with 9% reporting grade 3 or 4 severity events and none reporting grade 5. Prolonged cytopenia was experienced by 40% of patients, and 15% had grade 3 or worse infections.

“These results support liso-cel as a potential new treatment option for [relapsed or remitting] MCL, particularly in patients for whom limited therapies are available,” Dr. Wang concluded.

Reference

Wang M, Siddiqi T, Gordon LI, et al. Lisocabtagene maraleucel in relapsed/refractory mantle cell lymphoma: primary analysis of the mantle cell lymphoma cohort from TRANSCEND NHL 001, a phase I multicenter seamless design study. J Clin Oncol. 2024;42(10):1146-1157. doi:10.1200/JCO.23.02214