Dr Kamdar on the TRANSCEND NHL 001 Trial of Liso-Cel in Relapsed/Refractory MCL

Manali Kamdar, MD, associate professor, medicine, hematology-oncology; clinical director, Lymphoma Services, University of Colorado Anschutz School of Medicine, discusses the patient population included in the mantle cell lymphoma (MCL) cohort of the phase 3 TRANSCEND NHL 001 trial (NCT02631044) and highlights the trial design.

The primary analysis of the phase 3 study evaluated safety and overall response rates achieved with lisocabtagene maraleucel (liso-cel; Breyanzi) in patients with B-cell non-Hodgkin lymphoma, including MCL, Kamdar detailed. The complete response rate with this agent was robust, and the safety profile was highly tolerable. Grade 3 or higher cytokine release syndrome and neurotoxicity occurred in 3.2% and 10% of the patient population, respectively, she explains. Consequently, the FDA approved liso-cel for patients with relapsed/ refractory MCL following who had previously received 2 or more lines of treatment, Kamdar states.

Data from a subgroup analysis of responses achieved with liso-cel according to prior lines of therapy and BTK inhibitor exposure in this patient cohort were reported at the 2024 EHA Hybrid Congress. This single-arm analysis included patients aged 18 and over who had progressed on 2 or more lines of treatment, including an alkylator, a BTK inhibitor, and a CD20 antibody, Kamdar reports. Notably, patients were permitted to have undergone prior autologous or allogeneic transplant and have active or previously treated central nervous system (CNS) disease, she states.

A total of 104 patients were screened, and 88 received liso-cel at 1 of 2 dose levels: 50 × 10⁶ or 100 × 10⁶ CAR+ T cells. Overall, patients with MCL across all subgroups benefited from treatment with liso-cel, and response rates were generally comparable with those in the overall population.