Dr Nastoupil on the Investigation of Liso-Cel in Relapsed/Refractory Follicular Lymphoma

Loretta J. Nastoupil, MD, an associate professor, director of the Lymphoma Outcomes Database, and the section chief of New Drug Development in the Department of Lymphoma/Myeloma, Division of Cancer Medicine, at The University of Texas MD Anderson Cancer Center, discusses the safety and efficacy data from the phase 2 TRANSCEND FL trial (NCT04245839) evaluating lisocabtagene maraleucel (Breyanzi; liso-cel) in patients with relapsed/refractory follicular lymphoma.

Safety data were of particular importance in this study because observing efficacy with different agents in patients with follicular lymphoma is common; however, finding an agent with an acceptable toxicity profile that will not have a major effect on quality of life is key, Nastoupil says. Data for safety, which was evaluated in patients treated in the second line or later (n = 130), showed that the most common grade 3 or higher treatment-emergent adverse effects were cytopenias. Twenty-two percent of patients experienced prolonged cytopenia, and the rate of grade 3 higher infections was 5%. Cytokine release syndrome (CRS) was reported in 58% of patients; however, Nastoupil adds that most CRS was low grade. The rate of grade 3 CRS was 1%, and no grade 4 or 5 events were reported. 

Nastoupil adds that the study was designed to evaluate efficacy only in patients who were treated in the third-line setting or beyond. Findings showed that evaluable patients (n = 101) experienced an overall response rate of 97% (95% CI, 91.6%-99.4%; P < .0001). The complete response rate in this population was 94.1% (95% CI, 87.5%-97.8%). The median duration of response (DOR) and progression-free survival (PFS) were both not reached, and the 12-month DOR and PFS rates were 81.9% and 80.7%, respectively.

Notably, the PFS curves were somewhat different compared with other prior studies of liso-cel in other indolent lymphomas; rather than a faster drop before a plateau, more late events were reported, Nastoupil explains. She attributes that to potential responses to lymphodepleting chemotherapy with fludarabine/cyclophosphamide that was given prior to the administration of liso-cel.