Dr. Lunning on the FDA Approval of Liso-cel in LBCL

Matthew A. Lunning, DO, FACP, assistant vice chair of research in the Department of Medicine, assistant vice chancellor of clinical research, and associate professor of internal medicine in the Division of Hematology and Oncology at the University of Nebraska Medical Center, discusses how the FDA approval of lisocabtagene maraleucel (liso-cel; Breyanzi) expands treatment options for patients with large B-cell lymphoma (LBCL).

On June 24, 2022, the FDA approved liso-cel as second-line therapy for adult patients with LBCL, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B.

The indication is specific to patients who have refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy; or refractory disease to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and are not eligible for hematopoietic stem cell transplant (HSCT) due to comorbidities or age.

CAR T-cell therapy has proven effective in patients with DLBCL who relapse after 2 primary therapies, Lunning says. The phase 3 ZUMA-7 trial (NCT03391466) led to the first approval for CAR T-cell therapy in the second-line setting with axicabtagene ciloleucel (Yescarta) in patients with high-risk primary refractory disease or quick relapse after completion of therapy, Lunning adds.

Many high-risk patients may not survive long enough to be eligible for CAR T-cell therapies that are only approved for those who have received at least 2 prior lines of therapy, Lunning notes. The approval of liso-cel in the second line and beyond offers greater treatment availability to a vulnerable population, Lunning says. Cellular therapists now have another option to use with patients in the commercial setting, Lunning concludes.