Dr. Deol on the Approval of Brexucabtagene Autoleucel in MCL

Abhinav Deol, MD, associate clinical professor, Barbara Ann Karmanos Cancer Institute, discusses the approval of brexucabtagene autoleucel (Tecartus) in mantle cell lymphoma (MCL). 

In recent years, there have been several pivotal additions to the MCL armamentarium, says Deol. For example, the introduction of BTK inhibitors to this space has revolutionized the treatment paradigm for patients with relapsed/refractory MCL.

On July 24, 2020, the FDA granted an accelerated approval to brexucabtagene autoleucel, a CD19-directed CAR T-cell therapy, for the treatment of patients with relapsed/refractory MCL.

The approval was based on results from the phase 2 ZUMA-2 trial, which evaluated the product in patients with heavily pretreated, relapsed/refractory MCL, says Deol. Although the median number of prior therapies was 3, 81% of patients had received 3 or more prior treatments. 

Notably, due to the concern of infusing circulating mantle cells into patients, the manufacturing process of brexucabtagene autoleucel is different than others, such as axicabtagene ciloleucel (axi-cel; Yescarta).

In the ZUMA-2 study, brexucabtagene autoleucel led to an overall response rate of 87% and a complete response rate of 62%, which supported the subsequent approval, Deol concludes.