Dr Kambhampati on the Real-world Efficacy of Brexu-Cel in Heavily Pretreated Patients With MCL

Swetha Kambhampati, MD, hematologist/oncologist, assistant professor, Division of Lymphoma, Department of Hematology & Hematopoietic Cell Transplantation, City of Hope, discusses key findings from an analysis of real-world efficacy outcomes with brexucabtagene autoleucel (Tecartus; brexu-cel) in heavily pretreated patients with relapsed/refractory mantle cell lymphoma (MCL).

Using the CIBMTR observation database, a subgroup analysis was conducted to assess outcomes with brexu-cel in clinical practice for patients with MCL. Patients included the analysis had previously been treated with a BTK inhibitor, bendamustine, or autologous stem cell transplantation (ASCT), and had received either 1 to 2 or 3 or more prior lines of therapy. The median number of prior lines was 4 (range 1-12).

At total of 380 patients were included in the study from 84 centers across America. The overall response rate (ORR) in the overall population was 90%, including a complete response (CR) rate of 78%, Kambhampati reports. Notably, these response rates are similar to those from the phase 3 ZUMA-2 study (NCT02601313), in which brexu-cel had an ORR of 91% and a CR rate of 68%, Kambhampati adds. The median duration of response (DOR) in this cohort was 21.7 months.

Assessment of patient responses according to previous lines of therapy showed that patients who had received 1 or 2 prior lines had higher response rates and an increased likelihood of achieving a CR vs those who had received 3 or more lines, Kambhampati continues. Additionally, a multivariate analysis was onducted to analyze the effect of treatment types on efficacy outcomes. After adjusting for baseline characteristics like age, sex, and other disease characteristics, the analysis showed that exposure to prior BTK inhibitors or bendamustine did not affect efficacy and safety outcomes, Kambhampati expands. However, patients who previously underwent ASCT had improved progression-free survival, she notes.

Regarding safety, 88% of patients experienced any-grade cytokine release syndrome (CRS) and 60% experienced any-grade immune effector cell-associated neurotoxicity syndrome (ICANS), Kambhampati says. Grade 3 or higher CRS and ICANS events occurred in 10% and 28% of patients, respectively. Prior exposure to bendamustine was also associated with a decreased risk of exhibiting high-grade ICANS and prolonged thrombocytopenia, Kambhampati states. Patients who received 1 or 2 prior lines of therapy had higher rates of severe CRS compared with those who received 3 or more lines, Kambhampati details.

Ultimately, previous exposure to a given therapy did not greatly affect safety and efficacy with brexu-cel, Kambhampati says. Moreover, these safety and efficacy outcomes in clinical practice reflected those in clinical trials, she emphasizes. Further evaluation is needed to explore efficacy signals with the agent in patients who received it in earlier lines of therapy, Kambhampati concludes.

Dr Kambhampati had no relationships to disclosure.