Dr Gordon on the FDA Approval of Liso-Cel in Relapsed/Refractory MCL

Leo I. Gordon, MD, Abby and John Friend Professor of Oncology Research, professor, medicine (hematology and oncology), Feinberg School of Medicine, Robert H. Lurie Cancer Center, discusses the significance of the FDA approval of lisocabtagene maraleucel (liso-cel; Breyanzi) for patients with relapsed/refractory mantle cell lymphoma (MCL).

On May 30, 2024, the FDA approved the CAR T-cell therapy liso-cel for the treatment of patients with relapsed/refractory MCL who have received 2 or more prior lines of therapy, including treatment with a prior BTK inhibitor. This regulatory decision was based on findings from the MCL cohort of the phase 1 TRANSCEND NHL 001 trial (NCT02631044), in which 85.3% (95% CI, 74.6%-92.7%) of patients who received liso-cel achieved a response, including a 67.6% (95% CI, 55.2%-78.5%) complete response rate and a 12.2% partial response rate. Furthermore, 6.8% of patients had stable disease, and 6.8% of patients were not evaluable.

Previously, in 2020, the CAR T-cell product, brexucabtagene autoleucel (brexu-cel; Tecartus), was FDA approved for the treatment of adult patients with relapsed/refractory MCL, based on findings from the phase 2 ZUMA-2 trial (NCT02601313), which was led by Michael Wang, MD, of The University of Texas MD Anderson Cancer Center. Since that approval, brexu-cel has become the standard third-line therapy for patients with MCL, as many patients have achieved long-term remissions with this product, which may cure some patients of their disease, Gordon says.

Regarding liso-cel, the TRANSCEND NHL 001 trial enrolled a cohort of patients with heavily pretreated MCL across several sites in the United States, and the results in the MCL cohort supported the approval of liso-cel for patients with this disease, Gordon explains. This approval expands the MCL treatment paradigm with a CAR T-cell therapy that may be more tolerable than brexu-cel, Gordon emphasizes. Liso-cel is now a treatment option for patients with MCL who have relapsed after 1 or 2 prior lines of therapy, including a BTK inhibitor, Gordon concludes.