Dr Leslie on the Utility of Axi-cel in High-Risk LBCL

Lori A. Leslie, MD, director, Indolent Lymphoma and Chronic Lymphocytic Leukemia Research Programs, John Theurer Cancer Center, assistant professor, Hackensack Meridian School of Medicine, discusses the utility of treatment with axicabtagene ciloleucel (Yescarta; axi-cel) through the lens of the phase 3 ZUMA-7 trial (NCT03391466) in patients with high-risk, relapsed/refractory large B-cell lymphoma (LBCL).

The ZUMA-7 study was a randomized trial that investigated the efficacy of axi-cel, a CD19-targeted CAR T-cell therapy, compared with the standard of care, which includes high-dose chemotherapy and autologous stem cell transplant, in patients with high-risk, relapsed LBCL in the second-line setting, Leslie begins. Axi-cel has been FDA approved for use in patients with DLBCL in the third-line setting and beyond since 2017, demonstrating significant success in these later disease stages, Leslie says. Given this success, ZUMA-7 researchers aimed to evaluate the effectiveness of axi-cel earlier in the treatment process, she states.

The findings from the ZUMA-7 study were presented during the plenary session at the 2021 ASH Annual Meeting. The study demonstrated an improvement in the primary end point of event-free survival (EFS) for patients who received axi-cel directly, bypassing the standard high-dose chemotherapy and transplant treatment approach, Leslie reports.

The study focused on patients with high-risk, relapsed/refractory disease due to their historically poor outcomes with standard treatments, she explains. These patients often exhibit a high rate of chemorefractory disease and have generally experienced unsatisfactory results with conventional second-line therapies, according to Leslie. By showing a marked improvement in EFS with axi-cel, the ZUMA-7 study has significantly impacted the treatment paradigm for second-line DLBCL, Leslie explains.

Axi-cel's success in the second-line setting provides a new, more effective option for patients who have traditionally had limited success with standard therapies, Leslie says. This advancement underscores the potential of CAR T-cell therapy to transform treatment outcomes and improve the prognosis for patients with high-risk DLBCL earlier in the treatment continuum, she concludes.