Dr Gordon on the Clinical Implications of the TRANSCEND NHL 001 Trial of Liso-Cel in R/R 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 ComprehensiveCancer Center, update lower third discusses the clinical implications of findings from the mantle cell lymphoma (MCL) cohort of the phase 1 TRANSCEND NHL 001 trial (NCT02631044) evaluating lisocabtagene maraleucel (liso-cel; Breyanzi) in patients with relapsed/refractory B-cell non-Hodgkin lymphoma.

In May 2024, the FDA approved liso-cel for adult patients with relapsed or refractory MCL who have received at least 2 prior lines of systemic therapy, including a BTK inhibitor. This approval was supported by data from the MCL cohort of TRANSCEND NHL 001 and represents a significant advancement in the MCL treatment paradigm, providing a treatment option that is associated with lower toxicity compared with other MCLtherapies, Gordon begins. Liso-cel is a novel treatment approach for use by physicians and researchers, particularly for patients whose MCL has relapsed after 2 lines of therapy, he explains.

Data that led to this approval showed that in patients with relapsed/refractory MCL who had previously received at least 2 or more lines of therapy who were treated with liso-cel (n = 68), the overall response rate was 85.3% (95% CI, 74.6%-92.7%), including a complete response rate of 67.6% (95% CI, 55.2%-78.5%). Notably, several patients who participated in TRANSCEND NHL 001 in approximately 2016 to 2017 remain in remission after receiving liso-cel even after multiple prior treatments including bone marrow transplants, he expands. Patients in remission for over 2 years may be considered cured, Gordon reports.

This approval is particularly promising, and the next focus will be to assess liso-cel earlier in the treatment course, especially for high-risk MCL, he continues. There is also interest in improving the CAR T-cell construct or combining it with other agents to enhance its efficacy, Gordon reports, noting that the addition of liso-cel to the MCL treatment paradigm came at an opportune time, as researchers have been facing funding challenges. Ongoing support for basic research is critical, as it underpins these significant advances in the field, he concludes.