Dr. Hill on the FDA Approval of Brexucabtagene Autoleucel in Relapsed/Refractory MCL

Brian T. Hill, MD, PhD, director of the Lymphoid Malignancies Program and staff physician at Taussig Cancer Institute, as well as an assistant professor of Hematology and Oncology at the Cleveland Clinic, discusses the FDA approval of brexucabtagene autoleucel (Tecartus; formerly KTE-X19) for patients with relapsed/refractory mantle cell lymphoma (MCL).

The CAR T-cell product brexucabtagene autoleucel was approved for use in patients with MCL, says Hill. This agent is similar to that of axicabtagene ciloleucel (axi-cel; Yescarta), although it has a slightly different manufacturing process. The phase 2 ZUMA-2 trial supported the regulatory decision. Patients were eligible for the study if they did not respond or were intolerant to standard BTK inhibitors, such as ibrutinib (Imbruvica) or acalabrutinib (Calquence).

Historically, patients with MCL who relapsed after or become resistant to treatment with BTK inhibitors have a very short overall survival, as well as a very aggressive disease course, adds Hill. In the ZUMA-2 trial, patients achieved a very high objective response rate of 93%, while 57% achieved remission in the primary efficacy analysis. With the follow-up available, it appears that the majority of patients have durable remissions, explains Hill.